annex 3 compilation of the individual member states ... · compilation of the information received...

European Food Safety Authority - Largo N. Palli 5/a, I - 43100 Parma

Tel: (+39) 0521 036 111 • Fax: (+39) 0521 036 110 • [email protected] • www.efsa.europa.eu

Annex 3 Compilation of the individual

Member States responses to the Questionnaire

SCIENTIFIC COMMITTEE & ADVISORY FORUM UNIT



Parma, 20 December 2007 EFSA/AF/D/2007/68/RES

Advisory Forum

Working Group : Advisory Forum Title : Compilation of “Questionnaires on GMO Risk Assessment in

Europe” from Member States Submitted by : EFSA Secretariat Document for : X Information X Discussion Possible adoption Distributed to : X Advisory Forum On 08 Nov. 2007 X Participants in the meeting 08 Nov. 2007 X Advisory Forum 20 Dec. 2007 X Participants in the meeting 20 Dec. 2007 Confidentiality level : Confidential X For Restricted Use Only Public

1

INDEX Austria Latvia Page 94

Belgium Page 9 Lithuania Page 100

Bulgaria Page 19 Malta Page 105

Cyprus Page 24 The Netherlands Page 110

Czech Republic Page 30 Norway Page 117

Denmark Page 36 Portugal Page 122

Estonia Page 46 Romania Page 127

Finland Page 51 Slovakia Page 132

France Page 58 Slovenia Page 137

Germany Page 64 Spain Page 143

Greece Page 70 Sweden Page 149

Hungary Page 77 Switzerland Page 155

Ireland Page 84 United Kingdom Page 160

Italy Page 89

2



AUSTRIA

Questionnaire on GMO risk assessment in Europe BACKGROUND: This questionnaire is sent to each EFSA Advisory Forum member with the objective to collect information on the organisation, the approach and the procedures applied in the risk assessment of genetically modified organisms in each of the Member States of the European Union. The information provided through this questionnaire is useful for the preparation of the special meeting of the Advisory Forum on GMO Risk Assessment in Europe, that will take place on 13 November 2007. A compilation of the information received from the members shall be made available and published as a working document for the meeting and shall be presented to the European Commission. NOTICE: To avoid overlap of information, please read through all the questions prior to starting to answer. Use Tab to jump to the next answer.

1 Your country’s organisation for GMO risk assessment

1.1 Which organisation(s) is(are) responsible for performing the GMO risk assessment under Regulation (EC) No 1829/2003?

Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministry of Health, Family and Youth (CA, all aspects) in cooperation with the Austrian Agency for Health and Food Safety (AGES, all aspects with regard to food and feed use), the Umweltbundesamt Wien (UBA) - especially for environmental RA, Univ. for Vet. Med (toxicology) Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Ministry of Health, Family and Youth (CA, all aspects) in cooperation with the Austrian Agency for Health and Food Safety (AGES, all aspects with regard to food and feed use, detection method), the Umweltbundesamt Wien (UBA) - especially for environmental RA but also input in all aspects, Univ. for Vet. Med (toxicology) Number of applications assessed for which a national risk assessment report has been issued: all, which have been notified Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? no, but if the public is interested they are available and transmitted from the Ministry

3

1.2 Which organisation(s) is(are) responsible for performing the GMO risk assessment under Directive 2001/18/EC Part C (and Part B)?

Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of Health, Family and Youth (CA, all aspects) in cooperation with the Austrian Agency for Health and Food Safety (AGES, all aspects with regard to (food) and feed use of part C), the Umweltbundesamt Wien (UBA) - especially for environmental RA Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Ministry of Health, Family and Youth (CA, all aspects) in cooperation with the Austrian Agency for Health and Food Safety (AGES, all aspects with regard to food and feed use, detection method), the Umweltbundesamt Wien (UBA) - especially for environmental RA but also input in all aspects Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: for all notification, Austria never has been so far a lead country Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: some in the past, no current activity Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Commenting part B: no, but if the public is interested they are available and transmitted from the Ministry Deliberate release in Austria: Information would be put on the internet (http://www.gentechnik.gv.at, www.bmgfj.gv.at)

4

1.3 In case the risk assessments mentioned under 1.1 and 1.2 are carried out by different organisations, how is the coordination of the work of these different risk assessment bodies organised? See footnote 1

all comments are collected from the Ministry and a comprehensive statement is forwarded via EFSA-Net resp. to the EC

1.4 Can you briefly describe the interface between the risk assessor and the risk manager? Who ensures that the risk assessment and the risk management are appropriately linked for each application?

For 1829/2003 applications: Intensive cooperation between the two different departments at the Ministry (Dep. IV/B/8 RM - Dep. IV/B/9 - RA) For 2001/18 applications: Input from the above mentioned institutions are collected from the Ministry and a comprehensive statement is forwarded, RM-responsibility of the Ministry

2 Your national risk assessment Experts

Please specify for each question if the situation under Regulation 1829/2003 and under the Directive 2001/18 is different or not. If different, please specify the procedures under both legislations.

2.1 Can you indicate the number and the fields of competence of experts involved in the risk assessment per GMO application at national level?

For 1829/2003: 12 experts, covering all fields For 2001/18: 12 experts, covering all fields

1 Please indicate “not applicable” in case the GMO risk assessments are carried out by the same organisation.

5

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: not on the website of the Ministry but with certainty there are CVs available in the internet because all are international experts in the field of RA For 2001/18: see above

2.3 Are the assessments carried out by a scientific Panel of national experts? If otherwise, please describe how?

For 1829/2003: see 2.1., additionally experts of the scientific board on deliberate release and placing on the market can be involved for special advice For 2001/18: see above

2.4 Are the assessments adopted by consensus? If otherwise, please describe.

For 1829/2003: yes For 2001/18: yes

2.5 Is the scientific advice provided by written procedure or through discussion in meetings?

For 1829/2003: written procedure For 2001/18: written procedure

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: for 2.1. the membership does not expire automatically, for members of the scientific board a five-year period is foreseen, then generally the experts have to apply again and the Austrian Academy of Science selects the most qualified persons and transmits the proposals to the Ministries for appointment For 2001/18: see above

6

2.7 Are the national risk assessors employed as government officials and/or are they academics, consultants or others?

For 1829/2003: government officials and academics For 2001/18: see above

2.8 Do you have Declarations of Interest of each national expert to safeguard your experts’ independence?

For 1829/2003: no official declaration but the experts' independence is ensured For 2001/18: see above If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?

3 Your national risk assessment approach and methodology

3.1 Did your country issue its own risk assessment guidance document(s)?

Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: no but acc. to the Austrian gene-technology act the Ministry of Health finances risk-research. So far more than 40 research projects have been finalized in the past ten years. In the recent past also cooperations with the Ministry of Agriculture and the Ministry of Economy and Labour have been done for long-term-RA-studies. The output of these studies which also contain proposals for improving the current RA-procedures, is an input for the RA done by the Austrian experts. The studies are available free of charge via internet: http://www.bmgfj.gv.at/cms/site/bestelliste.htm?channel=CH0295

3.2 Does your country rely on GMO risk assessment guidance from other organisations?

yes, OECD, FAO/WHO, CODEX, EFSA

7

If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. no

3.3 Are there any national activities related to the development for risk assessment methodologies in the area of GMOs? Please describe.

they are ongoing, see 3.1. additionally the experts are involved in the current RA-discussion of EFSA (public consultations, meetings,…) for e.g.stacked events, toxicology, allergenicity and monitoring

3.4 Which future developments in GMO risk assessment methodologies would your country envisage?

see 3.3. and additionally soil-microflora

3.5 Do you wish to raise any particular issue on GMO risk assessment at the special EFSA Advisory Forum meeting?

In order to improve the risk assessment for GMOs there are several points which should be discussed in more detail: - Standardisation of the experimental setup (especially for field trials) and the statistical analyses of the data obtained from all studies (e.g. feeding studies, field trials) is absolutely necessary. Existing guidelines (e.g. CODEX, OECD) should be followed where they exist. - Parameters methods and endpoints have to be defined. The general guidance given by the EFSA Guidance document should be seen as a starting point only. - Clear guidance on the environments which should be covered by the field trials is needed, i.e. tests in the receiving environment are necessary. - Criteria for the evaluation of the data should be defined. E.g. How to determine "biological relevance"? How is "biological variation" defined?

8



BELGIUM




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Belgian Biosafety Advisory Council (BAC) (see <http://www.bio-council.be>) and Division of Biosafety and Biotechnology (SBB) of the Scientific Institute of Public Health (see <http://www.biosafety.be/SBB/SBB_1.html>) Both organisations are involved in the assessment of GM plants, GM microorganisms and GM animals. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes, both. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Areas of expertise of both organisations cover molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment.

9

Number of applications assessed for which a national risk assessment report has been issued: 6 (an additional 16 are being finalised for publication). Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, national risk assessment reports are made publicly available in English at the following weblink: <http://www.biosafety-council.be/bac_advices.html>.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Belgian Biosafety Advisory Council (BAC) (see <http://www.bio-council.be>) and Division of Biosafety and Biotechnology (SBB) of the Scientific Institute of Public Health (see <http://www.biosafety.be/SBB/SBB_1.html>) Both organisations are competent for the assessment of GM plants, GM microorganisms and GM animals. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes, both. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Areas of expertise of both organisation cover molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 10 (number does not cover notifications submitted in 2007 and submitted under Directive 90/220/EEC)

10

Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 3 (number does not cover notifications submitted in 2007 and submitted under Directive 90/220/EEC) Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, national risk assessment reports are made publicly available in English at the following weblink: <http://www.biosafety-council.be/bac_advices.html>. Moreover, detailed information (including risk assessment reports) on Part B applications under Directive 2001/18/EC is available at <http://biosafety.ihe.be/DTB/SearchTP.html> (for transgenic plants) and at <http://www.biosafety.be/gmomed/gmomed.html> (for GMO-medicinal products).


The coordination of the work between the two risk assessment bodies in Belgium is organised according to the provisions of the Cooperation Agreement between the Federal State and the Regions on the administrative and scientific co-ordination concerning Biosafety (see full text at http://www.biosafety.be/COOPAG/COOPAGEN.html). Accordingly, the Belgian Biosafety Advisory Council must be consulted by the Competent Authorities for the deliberate release of GMOs in the environment and the placing on the market of all GMOs and GMOs-based products. The Division of Biosafety and Biotechnology (SBB) ensures the secretariat of the Biosafety Advisory Council. It performs also risk assessment of applications for the deliberate release of GMOs in the environment or for the placing on the market of GMOs on mandate or upon request of the Biosafety Advisory Council. Both organisations are assisted in their work by external experts taken from a common list (see <http://www.bio-council.be/bac_experts.html>).


11


For 1829/2003 applications: The Biosafety Advisory Council is the primary interface between the risk assessor and the risk manager given to the fact that it is composed partly of representatives of the Regional and Federal competent authorities. As part of a Federal scientific Institute and as foreseen by the provisions of the aforementioned Cooperation Agreement, the Division of Biosafety and Biotechnology (SBB) closely works with all Regional and Federal competent authorities in the GMOs field. For 2001/18 applications: The Biosafety Advisory Council is the primary interface between the risk assessor and the risk manager given to the fact that it is composed partly of representatives of the Regional and Federal competent authorities. As part of a Federal scientific Institute and as foreseen by the provisions of the aforementioned Cooperation Agreement, the Division of Biosafety and Biotechnology (SBB) closely works with all Regional and Federal competent authorities in the GMOs field.




For 1829/2003: For each application under Regulation 1829/2003, a group of experts is established from a common list of external experts drawn up by the Biosafety Advisory Council and the Division of Biosafety and Biotechnology (SBB) (see <http://www.bio-council.be/bac_experts.html>). As far as possible, each group is composed of about 10 experts covering the following fields of competence: molecular

12

characterisation, environmental issues, toxicology, allergenicity and nutritional aspects. The opinions of the external experts form the scientific basis from which the Council drafts its final advice. In addition, the SBB (a multidisciplinary group of scientists) permanently provides administrative and scientific support to the Council and to the external experts during the risk assessment procedures. For 2001/18: For each Part B application under Directive 2001/18/EC, external experts (taken from the common list of external experts drawn up by the Biosafety Advisory Council and the Division of Biosafety and Biotechnology) are involved in the risk assessment. The number depends on the type of the dossier. Depending of the scope, the expertise covers all fields necessary to perform risk assessment as described in Directive 2001/18 , especially molecular characterisation, environmental isssues, toxicology, allergenicity and/or nutritional aspects. The opinions of the external experts form the scientific basis from which the Council drafts its final advice. In addition, the SBB (a multidisciplinary group of scientists) permanently provides administrative and scientific support to the Council and to the external experts during the risk assessment procedures. The same procedure applies for Part C applications introduced via the Belgian Competent Authorities. For all part C applications submitted via other Member States, the risk assessment is currently done by the SBB on mandate of the Biosafety Advisory Council.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: No. Only names and affiliations are publicly available. For 2001/18: No. Only names and affiliations are publicly available.

13


For 1829/2003: As mentioned before, the risk assessments are channelled through two organisations: - The Biosafety Advisory Council. The Council is composed of 12 effective and 12 substitute members designated by the Federal and Regional Ministers sharing competencies in the field of GMOs. Council's members are issued on the one hand from the competent authorities and on the other hand from the academic world. - The Division of Biosafety and Biotechnology (SBB). The SBB is a multidisciplinary group of scientists (about 20 people, mostly postgraduates) performing scientific expertise and laboratory research in the field of biosafety. As part of a Federal scientific Institute, the SBB holds an independent position with regard to its scientific expertise in biosafety. In the framework of the scientific evaluation of regulatory dossiers, the Biosafety Advisory Council and the SBB can surround themselves with the scientific support of external experts coming from universities and scientific institutions. For 2001/18: See above.


For 1829/2003: Yes. However, when a member of the Biosafety Advisory Council cannot agree with a Council's opinion or part of an opinion, he can add to that opinion a motivated declaration. For 2001/18: See above.

14


For 1829/2003: The scientific advices of the external experts are collected through a written procedure. When needed (i.e. in case of major divergence of views between experts), a meeting can be organised. At the Council's level, advices are generally finalised during plenary meetings. For 2001/18: For part B and part C applications introduced in Belgium: Same procedure as for applications under 1829/2003 (although external experts are in many cases convened to meetings for discussion). For part C applications introduced through other Member States: written procedure.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Members of the Biosafety Advisory Council are appointed for a period of 4 years (renewable). External experts are appointed for a period of 2 years (renewable). SBB staff is permanent. For 2001/18: Members of the Biosafety Advisory Council are appointed for a period of 4 years (renewable). External experts are appointed for a period of 2 years (renewable). SBB staff is permanent or contractual.


For 1829/2003: Council's members are issued on the one hand from the competent authorities and on the other hand from the academic world. External experts are academics. SBB members are scientists employed as officials of a Federal scientific Institute.

15

For 2001/18: Council's members are issued on the one hand from the competent authorities and on the other hand from the academic world. External experts are academics. SBB members are scientists employed as officials of a Federal scientific Institute.


For 1829/2003: Yes. Each time a national expert participates in the risk assessment of a dossier, he must sign a declaration of confidentiality and no conflict interest (see http://www.bio-council.be/bac_experts.html>). The same rule applies to the Council's members, but the declaration must be signed on an annual basis (see <http://www.bio-council.be/bac_rop.html>). Confidentiality also applies to SBB members. For 2001/18: See above. If yes, are the declarations of interest renewed annually or per topic? For the external experts: per dossier For the Council's members: annually For SBB members: duties as officials of a Federal scientific Institute If yes, are they published and if yes, where? No

16



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: 1. Guidelines for Molecular Characterisation of Genetically Modified Higher Plants for a Standard Part B Consent (2002, Division of Biosafety and Biotechnology) available at: http://www.biosafety.be/gmcropff/EN/TP/partC/GuideMGC_PartB_C.htm 2. Guidelines for Molecular Characterisation of Genetically Modified Higher Plants for a Simplified Part B Consent (2002, Division of Biosafety and Biotechnology) available at: http://www.biosafety.be/gmcropff/EN/TP/partC/GuideMGC_PartB_C.htm 3. Guidelines for Molecular Characterization of Genetically Modified Higher Plants to be Placed on the Market (2003, Division of Biosafety and Biotechnology) available at: http://www.biosafety.be/gmcropff/EN/TP/partC/GuideMGC_PartB_C.htm 4. Guidelines for Genetically Modified Stacked Events to be Placed on the Market (2007, Belgian Biosafety Advisory Council) available at: http://www.bio-conseil.be/ccb_role_2001_18.html 5.Guidance notes for the safety assessment of genetically modified crops for food and feed use (2003, Division of Biosafety and Biotechnology) available at: http://www.biosafety.be/gmcropff/EN/NF/GuidanceNotes/GuidanceFF.htm


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD, EMEA, Codex If not, can you specify in which area and explain why:

17

Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


No


-


See letter of the Belgian Biosafety Advisory Committee addressed to EFSA on 27 June 2007 (ref. BAC_2007_SC_547)

18



BULGARIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Bulgarian Ministry of Agriculture an Food Supply for GM feed; Bulgarian Ministry of Health for GM food Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): molecular biology, biotechnology, biology, ecology, nutrition, microbiology, toxicology, agriculture Number of applications assessed for which a national risk assessment report has been issued: Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Consultative Commission on GMOs with the Ministry of Environment and Water for GM plants and GMMs. GM animals are banned for release into the environment and placing on the market in Bulgaria. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to

19

dossiers? If not, please specify which. yes. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): molecular characterisations, toxicology, alergenicity, ERA Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: none Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: none Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? according to Bulgarian GMO Act all national ERAs should be publicly available in Bulgarian language. However, up to the moment no such ERAs exist.


No established co-ordination mechanism exists to date.


For 1829/2003 applications: commission of experts For 2001/18 applications: The Consultative Commission on GMOs reviews each application submitted and particularly the risk assessment and risk management part. During that process the Commission evaluates the eligibility of the risk management in the light of the presented risk assessment. All remarks the Commission may have on the adequacy of the risk management are reflected in the Commission's advise and are implemented into the authorisation decision.


20




For 1829/2003: 13 experts, field of competence - molecular biology, biotechnology, biology, ecology, nutrition, microbiology, toxicology, agriculture For 2001/18: 15 academic degree-holding scientists in the sphere of molecular genetics, molecular biology, ecology and environmental protection, modern biotechnology, agronomy, animal husbandry, biology and medicine and other spheres of science thereto related, representatives of the Bulgarian Academy of Sciences and other research organizations.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: For 2001/18: No.


For 1829/2003: Yes For 2001/18: Yes, the Consultative Commission on GMOs.


For 1829/2003: Yes For 2001/18: Yes

21


For 1829/2003: through discussions in meetings For 2001/18: Question is not precise. If it reffers to the scietific advise of the Consultative Commission on GMOs, it is provided by a written procedure to the minister of environment and water, respectively, minister of agriculture and food supply. If it reffers to the opinion of the members of the Commission, it is provided through discussion in meetings.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: For 2001/18: 4 year mandate.


For 1829/2003: government officals, academics, sscientific institutes For 2001/18: No, largely they are academics. Government officials participate in the work of the Consultative Commission only as observers in non-voting capacity.


For 1829/2003: For 2001/18: Yes. If yes, are the declarations of interest renewed annually or per topic? The procedure is not particularly established by law, but Ministry of Environment and Water intends to take the case-specific approach. If yes, are they published and if yes, where? No.

22



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: 2001/18 applications: no.


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA ( Guidance for the risk assessment of GM plants; Guidance for the risk assessment of GMMs), Codex, OECD (Safety Assessment of Transgenic Organisms: OECD Consensus Documents) If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. There is no difference.




23



CYPRUS




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” A National Committee on Genetically Modified plants, microorganisms and animals was established and is responsible for performing the GMO risk assesment under (EC) No 1829/2003 and 2001/18/EC. The Scientific Committee according to the law 160(I)/2003 is responsible for risk assessment for applications to the Cyprus competent authorities regarding deliberate release into the environment and placing in the market of GMOs (GM plants and GM animals). An ad-hoc Committee is responsible for risk assessment of other applications under Regulation 1829/2003 and 2001/18/EC. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. YES Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The National Committee has experts for all sectors of risk assesment. Scientific Committee: consists of experts from the following departments: environment service, department of labor inspection, department of medical services, institute of agricultural research, state laboratory, department of agriculture, one scientist specializing in natural ecosystems or molecular biology, one special scientist from the Federation of Environmental Organizations, one special scientist from the Consumer Protection Organization and one special scientist from the National Bioethics Committee. Number of applications assessed for which a national risk assessment report has been issued:

24

NONE. No application for GMOs has been send directly to Cyprus. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? No application for GMOs has been send directly to Cyprus.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: The National Committee on Genetically Modified plants, microorganisms and animals is responsible for performing the GMO risk assesment under (EC) No 1829/2003 and 2001/18/EC. The Scientific Committee according to law 160(I)/2003 is responsible for risk assessment for applications to the Cyprus competent authorities regarding deliberate release into the environment and placing in the market of GMOs (GM plants and GM animals). An ad-hoc Committee is responsible for risk assessment of other applications under Regulation 1829/2003 and 2001/18/EC. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. YES Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The National Committee has experts for all sectors of risk assesment. Same answer as before. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: None Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: None Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? No national risk assessment reports.


-N/A----


25


For 1829/2003 applications: Coordination of risk assesment and risk managment is done durring regular meetings of the National committee on GMOs. For 2001/18 applications: Coordination of risk assesment and risk management is done durring regular meetings of the National committee on GMOs.




For 1829/2003: The National committee is comprised by 7 permanent members but if there is a need for more experts the committee has the authority to request as many experts as needed. The permanent members experties includes Horticulture, Food Science, Biology , Microbiology. Invided members of the committee have expertiese in genetics and plant propagation, vetrenary science and lagal services. Scientific Committee consists of experts from the following departments: environment service, department of labor inspection, department of medical services, institute of agricultural research, state laboratory, department of agriculture, one scientist specializing in natural ecosystems or molecular biology, one special scientist from the Federation of Environmental Organizations, one special scientist from the Consumer Protection Organization and one special scientist from the National Bioethics Committee. For 2001/18: Same as above.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003:

26

No For 2001/18: No


For 1829/2003: Assesments are carried out by a scientific Panel of National experts. For 2001/18: Assesments are carried out by a scientific Panel of National experts.


For 1829/2003: They are adopted by consensus. For 2001/18: They are adopted by consensus.


For 1829/2003: Scientific advice is provided through discussion in the meetings of the National Commitee on GMOs. Minutes of the meetings are distributed to heads of related departments for review and consultations. For 2001/18: Same as above.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: No exparation date on the appointed experts panel has been set up. For 2001/18: Same as above.


For 1829/2003: The permanent panel of experts of the National commitee are employed as government officials but invided experts / consultants may come from the private sector. For 2001/18: Same as above.

27

The Scientific Committee has 6 members from the government sector, 3 scientists from NGOs and 1 expert that can be called upon request from the private sector.


For 1829/2003: Each member of our experts panel signs a declaration of non conflict of interest before each meetinig of the National committee. For 2001/18: Same as above. If yes, are the declarations of interest renewed annually or per topic? The declarations have been signed once, no renewal. If yes, are they published and if yes, where?



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: NO


YES If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): WHO, Codex, EFSA. If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. NO


NO

28


No further developments in GMO risk assessment methodologies are expected.


As above.

29



CZECH REPUBLIC




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministry of Agriculture is responsible for all GMO and derived products Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Molecular characteristic, toxicology, alergenicity, environmental risk assessment, nutrition Number of applications assessed for which a national risk assessment report has been issued: 15 Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? not at the moment, it would be in Czech


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of the Environment of the Czech Republic is the responsible Authority for environmental risk assessment of all GMOs. It co-operates with the Ministry of Health and Ministry of Agriculture. An expert advisory body to the Ministry of the Environment is the Czech Commission for the Use of GMOs and Genetic Products. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to

30

dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Ministry of the Environment and its expert Commission: environmental risk assessment, molecular characterisation, compositional analysis, risk management measures Ministry of Health: nutrition, toxicology, allergenicity Ministry of Agriculture: agronomical characteristics and effects Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 13 Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 12 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? A summary information on each notification, incl. conclusions form the e.r.a. is published in Czech on the webpage of the Ministry of the Environment.


Coordination is realized by close contacts among the relevant ministerial departments and expert bodies.


For 1829/2003 applications: There are two advisory bodies at the Ministry of Agriculture - Scientific committee for GM food and feed dealing with risk assessment srtricly according to EFSA guideline and Comitte for GM crop dealing with risk management, namely co-existence, buffering zones. National reference laboratory at CRI Prague, Laboratories at Czech Agriculture and Food Authority, Inspectorate State veterinary Institute and Central Institute for Supervising and Testing in Agriculture For 2001/18 applications: The Ministry coordinates the risk assessment (performed by the experts) and the risk management measures by setting the requirements in the authorisations. The Competent Authority on state supervision of the use of GMOs is the Czech Environmental Inspectorate that cooperates with the Ministry as well.


31




For 1829/2003: Scientific committee for Genetically Modified Food and Feed - 12 members . at least: 7 experts for food/feed safety including alergology, toxicology, 3 molecular characterisation, detection methods 2 environmentl issues. For 2001/18: Czech Commission for the Use of GMOs and Genetic Products: maximum 15 members, of that at least 2 experts for GM plants, 2 experts for GM animals, 2 experts for GM microorganisms, 1 biologist/ecologist, 1 expert for laboratory detection of GMOs, 1 expert for GM food and relevant legislation, 1 expert for agriculture and relevant legislation, 1 expert for health care, farmacology and relevant legislation,2 experts for GMO supervision, incl. export and import.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: yes: http://www.scgmff.cz/ For 2001/18: No


For 1829/2003: Yes - Scientific committee of GM food and feed at the Ministry of Agriculture For 2001/18: Yes


For 1829/2003: In case of objections raised by a member (members) of the Scientific Committee there is a vote. For 2001/18:

32

In case of objections raised by a member (members) of the commission there is a vote.


For 1829/2003: by written procedure For 2001/18: Usually by a written procedure, outstanding issues and objections are discussed in meetings.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: 5 years For 2001/18: 2 years


For 1829/2003: academics, researchers, consultants For 2001/18: all of these possibilities


For 1829/2003: Yes For 2001/18: Yes If yes, are the declarations of interest renewed annually or per topic? Per notification If yes, are they published and if yes, where? No

33



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Risk assessment is based on EFSA guideline, Codex Alimentarius guidelines may be taken into account if appropriate


We use/consider risk assessment guidance from other organisations. If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): OECD, EFSA and other EU institutions (guidance notes to the Directive) If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. Assessment is done by two independent comission at two different Ministries. Scientific committee of GM food and feed at the Ministry of Agriculture is responsible for food/feed safety risk assesmment, comment as well on bio-safety if appropriste, Czech Commission at the ministy of the Environment is responsible for living GMOs not for food and feed.


It is the task of Scientific committee for GM plant and feed to evaluate the available guidelines based on the work of interational bodies as EFSA, Codex Alimentarius, OECD and perhaps proposed amendment to that quidelines


Specificly involve people having experinecein nutritional studies able to extrapolate the results on animal, tissue culture models zo human situation


Risk/benefit approach. Long-term effects of GMO consumption, e.g. if several crops produce Bt endotoxin the consumption of the particular may increase (Bt corn, Bt potatoes, oils from Bt cotton, etc.) .

34

It is known that acute toxicity is extremly low. But we have no infomation of long-term exposion. It is possible to rely on available model ? Should not be envisage to companies to run feeding study in a repetitive manner (same organisms, same genotype, numbers)

35



DENMARK




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” 1) Danish Veterinary and Food Administration is the competent authority for 1829/2003 and responsible for the overall risk assessment and normally ask the scientific expert when appropriate: 2) National Food Institute, Technical University of Denmark is the scientific expert risk assessment in GMO (GMM, GMP and GM-animals) and health risk 3) The Danish Plant Directorate is the expert instistution in risk assessment of molecular and agricultural issues. 4) The Danish National Environmental Research Institute at the University of Aarhus is the expert in risk assessment of environmental issues of GMP Below reference to these organisationes are indicated as 1), 2) 3) and 4) Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. All of the involved scientific experts have access to the EFSA net. Commenting is normally through the competent authority Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): 1) Overall responsible and coordinator 2) Molecular characterisations, compositional analysis, nutrition, allergenicity and generel risk assessment of food

36

3) Molecular characterisations, compositional analysis, cultivation, seed dispersal and detection methods. 4) Invasibility, non-target effects, general environmental risk assessment Number of applications assessed for which a national risk assessment report has been issued: Since 1986 risk assessments have been made for the authority. The documents are normally regarded as internal documents not directly available but referred to (eg. by citation) in the final evaluation from the Danish authority. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? See previous answer. The documents are written in Danish.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: 1) Danish Environmental Protection Agency is the competent authority for 2001/18/EC and responsible for the overall risk assessment and normally ask the scientific expert when appropriate: 2) National Food Institute, Technical University of Denmark is the scientific expert risk assessment in GMO (GMM, GMP and GM-animals) and health risk 3) The Danish Plant Directorate is the expert institution in risk assessment of GM-plants, agronomy issues and seeds 4) Danish National Environmental Research Institute at the University of Aarhus is the expert in environmental issues Is (are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. All of the involved scientific experts have access to the EFSA net. Commenting is normally through the competent authority Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment):

37

1) Overall responsible and coordinator 2) Molecular characterisations, compositional analysis, nutrition, allergenicity and generel risk assessment of food 3) Molecular characterisations, compositional analysis, cultivation, seed dispersal and detection methods. 4) Invasibility, non-target effects, general environmental risk assessment Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: We have not received comments from the Danish Environmental Protection Agency – they know the answer. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: We have not received comments from the Danish Environmental Protection Agency – they know the answer. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? We have not received comments from the Danish Environmental Protection Agency – they

38

know the answer.


Although the responsible national authorities of the two regulations are different authorities they normally use the same institutions for the scientific risk assessment but may also use other experts. In principle the institutions mentioned above are doing the risk assessment in all cases in their field when relevant irrespectable of the regulation. The two Institutions, the Danish National Environmental Research Institute and the Plant Directorate mentioned (no. 2, 3 and 4 under 1.2) are responsible for building up the expertise in their respective fields in order to give scientific advice about GMO's


39


For 1829/2003 applications: The Danish Veterinary and Food Administration is the competent authority for 1829/2003 and responsible for the overall risk assessment and normally ask the dedicated Institutions with the scientific expert when appropriate. How the input from the scientific experts are used is the responsibility of the authority: The Danish Plant Directorate is responsible for the risk management of feed under 1829/2003. The risk assessment of feed is carried out by EFSA. The department of feed at the Plant Directorate is not directly involved in the feed risk assessment before the EFSA opinion is issued. For 2001/18 applications: The Danish Environmental Protection Agency is the competent authority for 2001/18/EC and responsible for the overall risk assessment and normally ask the dedicated Institutions with the scientific expert when appropriate. How the input from the scientific experts are used is the responsibility of the authority.

The Danish Environmental Protection Agency carries out the risk management. We have not received their comments.




For 1829/2003:

40

See 1.1 above The number of experts involved is decided case by case by the Institutes. E.g. the National Food Institute may use 7 different expert representing experts in the field toxicology, nutrition, allergenicity, animals tests, botanic, agronomy, genetic engeneering and risk assessment of chemicals. The Danish National Environmental Research Institute have five accredited experts plus three staff members with specific knowledge in plant invasion, gene dispersal, pesticide toxicology, environmental risk assessment and monitoring. The Plant Directorate has 3 experts representing different areas: Molecular characterisation detection methods, compositional analysis, cultivation, seed dispersal and risk assessment. For 2001/18: See 2.1 above The number of experts involved is decided case by case by the Institutes. E.g. the National Food Institute may use 7 different expert representing experts in the field toxicology, nutrition, allergenicity, animals tests, botanic, agronomy, genetic engeneering and risk assessment of chemicals. The Danish National Environmental Research Institute have five accredited experts plus three staff members with specific knowledge in plant invasion, gene dispersal, pesticide toxicology, environmental risk assessment and monitoring. The Plant Directorate has 3 experts representing different areas: Molecular characterisation and detection methods, compositional analysis, cultivation, seed dispersal, and risk assessment.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: 2) Most of the relevant CV's from the Institute should be found at http://www.dfvf.dk under the english version e.g. http://www.dfvf.dk/Default.aspx?ID=20690 The relevant CV's for the experts from NERI can be found at: http://www.dmu.dk/International/Environment+and+society/Genetically+modified+plants/ or http://www.sns.dk/biosafety/eksperter/eksperter.htm CV's from experts from the Danish Plant Directorate are not publicly available. For 2001/18: 2) Most of the relevant CV's from the Institute should be found at http://www.dfvf.dk under the english version e.g. http://www.dfvf.dk/Default.aspx?ID=20690.

41

The relevant CV's for the experts from NERI can be found at: http://www.dmu.dk/International/Environment+and+society/Genetically+modified+plants/ or http://www.sns.dk/biosafety/eksperter/eksperter.htm CV's from experts from the Danish Plant Directorate are not publicly available.


For 1829/2003: The scientific risk assessments are carried out by the responsibility of the Institutes where the experts are employed and are participating in the advisory work. At some institutions experts are also doing research in their specific fields. For 2001/18: The scientific risk assessments are carried out by the responsibility of the Institutes where the experts are employed and are participating in the advisory work. At some institutions experts are also doing research in their specific fields.


For 1829/2003: In principle the involved Institutions 2), 3) and 4) are dealing with different fields and there are normally no needs for consensus. In case of conflicting scientific evaluations the problems have been solved by the competent authority involving the respective experts. Scientific issues not (thoroughly) dealt with in the evolution from the scientific experts but needed by the competent authority e.g. as brought about from a public hearing, will be taken up be the experts when asked for advice on the topic. For 2001/18: Same as for 1829/2003

42


For 1829/2003: By written procedure For 2001/18: By written procedure

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: No defined period but pointed out by the Institute among the experts/employees For 2001/18: No defined period but pointed out by the Institute among the experts/employees


For 1829/2003: The experts are employed at scientific institutions or authorities under different ministries For 2001/18: The experts are employed at scientific institutions or authorities under different ministries


For 1829/2003: Not beyond a general statement For 2001/18: Not beyond a general statement If yes, are the declarations of interest renewed annually or per topic?

43

If yes, are they published and if yes, where?



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: No National guidelines are used but the EU guidelines supplemented by other international guidelines (e.g. CODEX, OECD and Nordic reports) as well as scientific literature


See 3.1 Yes relying on EFSA’s opinion on feed issues If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): See 3.1 EFSA If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.

44


No specific activity pt beyond the normal gain of experience form reading the scientific literature and participating in international group dealing with this issue (Codex and OECD). NERI participates in an EU-working group on monitoring.


More focus may be given to the risk-benefits Based on the scientific experience in the GMO area the discussion may in the future be that in areas where no unexpected outcome or risks have been seen there could be more simplified applications. In cases where the need for animal test is decided, guidelines for testing of whole food is not in place and there are still need for further discussion on this topic.


45



ESTONIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” The Veterinary and Food Board is responsible for risk assesment of GM plants, GM microorganisms and GM animals under Regulation No 1829/2003. The Veterinary and Food Board takes into account the opinion of the Advisory Committee of Novel Foods. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The Advisory Committee of Novel Foods consist of experts in different fields: food technology, food chemistry, biotechnology, gene technology, toxicology, microbiology, nutrition science and each expert focuses on his field. Number of applications assessed for which a national risk assessment report has been issued: We have not issued any risk assesment report. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? See previous point.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”:

46

The Advisory Committee for Genetic Modification under the Ministry of Environment has been set up to advise the minister of environment on the issues of deliberate release of GMOs (GM plants, GM animals and GM microorganisms) into the environment and marketing of GMOs (applications according to Directive 2001/18/EC). Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The Advisory Committee for Genetic Modification evaluates all areas of expertise with special attention to environmental risk assesment. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: None. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: None. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Non-public.


Risk assesment under Regulation No 1829/2003 is carried out by the Advisory Committee of Novel Foods under the Ministry of Agriculture. Risk assesment under Directive 2001/18/EC is carried out by the Advisory Committee for Genetic Modification under the Ministry of Agriculture.There are several members belonging to both Committees.


For 1829/2003 applications: The official from the Veterinary and Food Board asks opinion from the members of the Advisory Committee of Novel Foods. The Veterinary and Food Board, as national competent authority within the meaning of article 5 (2) of Regulation 1829/1003, is responsible for risk assesment carried out by the Advisory Committee of Novel Foods. For 2001/18 applications: The Advisory Committee for Genetic Modification is responsible for that the risk assesment is appropriately linked with its management. Since we do not have any experience, it is impossible to describe the interface.


47




For 1829/2003: There are 13 members in the Advisory Committee of Novel Foods, 9 of them are academics, who are involved in the risk assesment. About the field of competence please see point 1.1. For 2001/18: There are 17 members in the Advisory Committee for Genetic Modification, 9 of them are academics, 3 are NGO-s and 5 from different governmental institutions.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: No. For 2001/18: No.


For 1829/2003: Yes. For 2001/18: Yes.


For 1829/2003: The decisions are adopted by simple majority of votes. For 2001/18: The decisions are adopted by simple majority of votes.

48


For 1829/2003: The scientific advice is usually provided by written procedure, but both procedures are acceptable by decree. For 2001/18: It depends on the complexity of assesment, both as written procedures and discussions in meetings have been implemented.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Not specified. For 2001/18: Our national Panel is appointed for an unspecified term.


For 1829/2003: All national risk assessors are academics and we are going to pay for every expert opinion from state budget. For 2001/18: Government officials and academics belong to the Advisory Committee for Genetic Modification, officials are not paid by government. Others have contracts and they are paid from state budget.


For 1829/2003: No. For 2001/18: No. If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?

49



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: We do not have our own risk assesment guidance document for 1829/2003 application. For 2001/18 applications, in general we follow EU guidance. A special guidance document is being prepared under UNEP/GEF/PROJECT implementation of national biosafety framework, supposing it will be ready in 2008.


If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): For Regulation 1829/2003 applications, the Veterinary and Food Board relies on EFSA guidance document. For Directive 2001/18 applications EFSA, OECD and UNEP guidance materials are used. If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


No.


None.


No.

50



FINLAND




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” - The Novel Food Board (UEL) (plants, animals and micro-organisms used for food) - Finnish Food Safety Authority Evira (plants and micro-organisms used for feed) - The Board for Gene Technology (GTLK) (enviroment) - Finnish Environment Institute (SYKE) (plants, micro-organisms, animals) - Agrifood Research Finland (MTT) (plants, micro-organisms, animals) Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes, all organisations except MTT have access to dossiers directly via EFSAnet. Evira, SYKE and MTT give expert statements and comment the dossiers to the Finnish competent authorities. The Board for Gene Technology and the Novel Food Board may comment these dossiers. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): - molecular characterisation: SYKE, Evira - compositional analysis: Evira, UELK - nutrition: UELK, MTT - toxicology, allergenity: UELK - environmental risk assessment: SYKE, MTT Number of applications assessed for which a national risk assessment report has been issued: No full risk assessment has been carried out by any of the bodies. However for food safety assessment the Novel Food Board studies the EFSA report along with the dossier submitted by the applicant. The emphasis is on the gmo’s safety as food and special

51

consideration is done as regards the nutritional and toxicological safety as well as the allergy potential. In case of feed, the animal nutritionist(s) of MTT maybe asked to assess the feed safety aspects of the EFSA report along with the dossier submitted by the applicant. All EFSA applications have been assessed by Evira and SYKE. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? The decisions of competent authorities and the opinions of expert organisations are public in Finnish but not available in web.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Expert authorities and institutions in the field of gene technology are responsible for giving opinions to the Board for Gene Technology (GTLK) and acting even otherwise as experts in gene technology. The expert authorities and institutions in the field of gene technology are: - the Finnish Environment Institute (SYKE) (plants, micro-organisms, animals) - Finnish Food Safety Authority Evira (plants, micro-organisms, animals - Agrifood Research Finland (MTT) (plants, micro-organisms, animals) and also in their respective fields of competence National Public Health Institute, the National Agency for Medicines, the Forest Research Institute, the Game and Fisheries Research Institute, the National Product Control Centre for Welfare and Health, the Institute of Occupational Health, and the Technical Research Centre (VTT). The Board for Gene Technology may, as necessary, also turn to other expert institutions than those mentioned above. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. GTLK, SYKE and Evira have access to dossiers, but the Board for Gene Technololy complies the comments and send these comments directly to EFSA. . Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): - molecular characterisation: SYKE, Evira - compositional analysis: Evira - nutrition: MTT - environmental risk assessment: SYKE, MTT Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: The Board for Gene Tecnology prepares written decisions of all applications. All EFSA applications have been assessed by Evira and SYKE. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: Approximal 20 applications for field trials. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which

52

language and could you provide the reference or weblink if applicable? SYKE and Evira gives statements and comment the dossiers to the Finnish competent authority. The opinions of expert institutions are public in finnish but not available in web. The minutes and decisions of the Board for Gene Technology are public and available in web: http//www.geenitekniikanlautakunta.fi/kokoukset.html.


For 1829/2003 the expert authorities and institutions are responsible for giving opinions to competent authorities which are Finnish Ministry of Agriculture and Forestry, the Ministry of Trade and Industry and the Board for Gene Technology. These organisations together discuss to find the consensus. The Novel Food Board operates in conjuction with the Ministry of Trade and Industry responsible for food legislation in Finland. For 2001/18 the Board for Gene Technology is the competent authority (seven members of the Board representing the Ministries of Agriculture and Forestry, Trade and Industry, Social affairs and Health, Environment and also Ethical expertise is represented in the Board.) A national governmental decree (VNa 910/2004) gives provisions for the national coordination under the regulation 1829/2003/EC and accordingly a coordinated common view is to be formed in concensus


For 1829/2003 applications: The expert and control bodies are the same and they are operating under same ministeries: Finnish Ministry of Agriculture and the Ministry of Trade and Industry. As above the consessus opinion is formulated by organisations who are in close contact with the risk assessment bodies. Risk assessors are commissioned to carry out their independent risk assessment by the competent authorities responsible for risk management i.e. there is a direct link between the two partners for each application. The assessments/opinions are submitted for the risk managers’ use as appropriate. A national Governmental decree (VNa 910/2004) defines the responsibilities and competencies of all relevant bodies (risk assessment, risk management, enforcement) as well as gives provisions for the national coordination under the regulation 1829/2003/EC. For 2001/18 applications: The members of the Board of Gene Technology represent the Ministry of Trade and Industry, the Ministry of Agriculture and Forestry, the Ministry of Social Affairs and Health and the Ministry of the Environment and a member taking care of ethical issues.


53




For 1829/2003: 5-10 experts of different fields of competence For 2001/18: 3-10 experts of different fields of competence

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: Yes, upon request. For 2001/18: Yes, upon request.


For 1829/2003: For food safety the scientific panel for experts is the Novel Food Board. For feed safety there is no scientific panel of national experts in Finland. The expert authorities and institutions give independently expert opinions of gmo-applications to the competent authorities. For 2001/18: There is no scientific Panel of national experts in Finland. The expert authorities and institutions give opinions of gmo-applications to the competent authorities.

54


For 1829/2003: For food yes. The initial assessment is carried out by 3-4 on case-by-case basis nominated experts but the final adoption of their draft opinion is done by the Novel Food Board as a whole and consisting of 20 experts in the field of food sciences, biotechnology, toxicology, molecular biology, medicine and allercology). The draft is discussed face to face in the boards meeting and a final concencus opinion is issued to be given to the competent authority (risk manager in food sector) for further use." . For 2001/18: The decision of the Board for Gene Technology is qualified majority decision.


For 1829/2003: Both For 2001/18: Both

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: The Novel Food Board and its members are nominated for 3 year periods at time. There is no restriction for how many periods an expert may be nominated. Other national expert institutes and authorities are appointed in the national legislation. No personal nominations are made. For 2001/18: National expert institutes and authorities are appointed in the national legislation. No personal nominations are made.


For 1829/2003: In the food sector the members of the Novel Food Board are leading scientists in the universities or governmental research institutions or non-governmental organisations i.e.

55

they are academics. In the feed sector or for environmental matters the opinions are prepared by governmental officials and academics. For 2001/18: Expert opinions of the GMO-applications are prepared by governmental officials and academics.


For 1829/2003: The integrity of civil servants is ensured by law. Additionally for the Novel Food Board Members declaration of interest is clarified for each opinion (dossier). For 2001/18: The integrity of civil servants is ensured by law. If yes, are the declarations of interest renewed annually or per topic? For the Novel Food Board members reviewed per topic If yes, are they published and if yes, where? For the Novel Food Board published as part of the minutes of the Novel Food Board meeting in which the assessment/dossier was discussed. The minutes are published in the Ministry of Trade and Industries web page.



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Guidelines for the assessment of environmental effects og genetically modified organisms (1998), SYKE/Jyrki Pitkäjärvi and Marja Ruohonen-Lehto, applied for both 1829/2003 applications and 2001/18 applications. Written in finnish.


Yes

56

If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, guidance notes for directive 2001/18, OECD, CODEX If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


The Academy of Finland, Ministry of Agriculture and Forestry, and Ministry of the Environment have funded a Research Programme on Environment, Societal and Health Effects of Genetically Modified Organisms for 2003-2007. SYKE, University of Helsinki and University of Tampere have been involved in developing Environmental Risk Assessment Framefork and Models for risk assessment.


Methodologies for environmental monitoring.


Borderline between general surveillance and case-specific monitoring.

57



FRANCE




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” AFSSA (Agence française de Sécurité Sanitaire des Aliments) is in charge of assessment of these three types of GMO Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. YES Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Molecular characterisations, compositional analysis, nutrition, toxicology and allergenicity assessment Number of applications assessed for which a national risk assessment report has been issued: All dossiers have been evaluated by Afssa since 1999 under directive 90/220 concerning feed products and under regulation n° 258/99 for food products issued from GMO. Then all dossiers under regulation n° 1829/2003 related to food and feed products have been evaluated by AFSSA on request of the French authorities. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? National assessment reports are published in French on AFSSA website www.afssa.fr


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM

58

animals”: The "Commission du Génie Biomoléculaire" is in charge of the environmental risk assessment under the supervision of Ministery of Agriculture. AFSSA is not involved in this risk assesment field. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?


A scientific officer of Afssa attends the "Commission du Génie Biomoléculaire" meetings which is in charge of environmental assessment of GMO. Some common meetings are organized on different issues (gene flow, antibiotic resistance gene, toxicology of pesticides)


For 1829/2003 applications: AFFSA receives GMO dossiers from the Ministery for Consumer Affairs. After evaluation by AFSSA, assessment reports are sent to Comsumer Affairs. Consummer Affairs is in charge of the management of risks (monitoring and controls, regulation, implementation of the management measures of risks) For 2001/18 applications:


59




For 1829/2003: 19 experts are involved in the GMO risk assessment. They are molecular biologist, toxicologist, specialist in animal nutrition, veterinary, agronomist, microbiologist, food process engineering. For 2001/18:

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: Expert's CV are not publicly available but the declarations of interest forms filled in by the experts are published (see 2.8) For 2001/18:


For 1829/2003: All the risk assessments are carried out by the scientific panel "Biotechnology experts Committee" For 2001/18:


For 1829/2003: Opinion prepared by the scientific panel is adopted by consensus. If an expert cannot meet the common opinion, this minority opinion is indicated at the end of the AFFSA opinion. For 2001/18:

60


For 1829/2003: A opinion project is prepared by the scientific officer in charge of the Panel, based on the expert reports. Then, during the Panel meeting, this project is discussed and amended. At the end of meeting, an opinion is adopted by the Panel. This opinion becomes the AFSSA opinion. For 2001/18:

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: For three years. Every three years, Afssa's Panel is renewed after a public call for applicants For 2001/18:


For 1829/2003: They come from universities and public research institutes. No consultants or experts from industry, neither government officials. For 2001/18:


For 1829/2003: Each expert has to fill in a declaration of interest. For 2001/18: If yes, are the declarations of interest renewed annually or per topic? Regularly, experts (at least every year) are invited to update their declaration of interest If yes, are they published and if yes, where? Any declaration of interests is made available on request and published on AFSSA's official bulletin.

61



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Before the publication of the EFSA guidance, Afssa carried out its own guidance which have been published on the Afssa website in January 2002 and communicated to EFSA when EFSA updated the European Committee of plants guidance. Now, EFSA guidance which is very close to the Afssa guidance is used.


Codex and OECD recommandations are less restrained than European risk assessment. Before EFSA guidance, methodology of allergenicity risk assessment proposed by Codex was used by AFSSA If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


AFSSA has worked on the issue of GMO benefices and on the possibility to develop a methodology for evaluating these benefices. AFSSA has worked also on food allergy. This issue has been investigated in relation to the development of GMO and their consumption.


No future development is planned


1 A new approach of GMO, based on the identification of benefices could be developped in the framework of a benefices/risks balance. 2 It could be interesting to carry out an evaluation of national agencies contributions to

62

EFSA risk assessments in matter of GMO.

63



GERMANY




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Competent Authority for all GMOs: Federal Office of Consumer Protection and Food Safety (BVL) Other authorities taking part in the risk assessment: Federal Agency for Nature Conservation (BfN); for all GMOs Federal Institute for Risk Assessment (BfR); for all GMOs Robert Koch Institute (RKI); for all GMOs Federal Biological Research Centre for Agriculture and Forestry (BBA); for all GMOs Friedrich Loeffler Institute (FLI); for GM vertebrate animals and GM microorganisms that are applied on vertebrate animals Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): BVL: all areas of GMO risk assessment; BfN: mainly environmental risk assessment; BfR: mainly compositional analysis, toxicology, allergenicity; RKI: mainly human health, medicinal aspects; BBA: mainly areas related to the use of GMOs in agriculture and forestry; FLI: mainly animal vaccines and GM vertebrate animals Number of applications assessed for which a national risk assessment report has been issued: - Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?

64

-


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Competent Authority for all GMOs: Federal Office of Consumer Protection and Food Safety (BVL) Other authorities taking part in the risk assessment: Federal Agency for Nature Conservation (BfN); for all GMOs Federal Institute for Risk Assessment (BfR); for all GMOs Robert Koch Institute (RKI); for all GMOs Federal Biological Research Centre for Agriculture and Forestry (BBA); for all GMOs Friedrich Loeffler Institute (FLI); for GM vertebrate animals and GM microorganisms that are applied on vertebrate animals Paul Ehrlich Institute (PEI); for GM vertebrate animals and GM microorganisms that are applied on vertebrate animals Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): BVL: all areas of GMO risk assessment; BfN: mainly environmental risk assessment; BfR: mainly compositional analysis, toxicology, allergenicity; RKI: mainly human health, medicinal aspects; BBA: mainly areas related to the use of GMOs in agriculture and forestry; FLI: mainly animal vaccines and GM vertebrate animals PEI: mainly human vaccines Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 1 Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 170 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Part C: http://gmoinfo.jrc.it/csnifs/C-DE-02-09_RiskAssessment.pdf The public has access to Part B risk assessment reports for 1 month after the authorization was granted. The reports are not available via the Internet.

65


The BVL asks the other authorities for their opinions on the applications. The BVL decides on the applications, taking into account the opinions of the other authorities.


For 1829/2003 applications: BfN, BfR, RKI, BBA, and in some cases FLI take part in the risk assessment and make recommendations for risk assessment measures. The BVL carries out the final risk assessment and decides on risk management measures. For 2001/18 applications: BfN, BfR, RKI, BBA, and in some cases FLI and PEI take part in the risk assessment and make recommendations for risk assessment measures. The BVL carries out the final risk assessment and decides on risk management measures.




For 1829/2003: As an important step in the risk assessment procedure, the BVL asks for a statement from the "Central Commission for Biological Safety" (ZKBS). Members of the ZKBS are: - 10 experts in different areas of science: microbiology (1), cell biology (1), virology (2), genetics (2), ecology (2), hygiene (1), safety technology (1); - 6 representatives of different stakeholder groups: trade unions, worker protection, industry, environmetal protection, consumer protection, research supporting organisations.


66

For 2001/18: same as for 1829/2003

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: no For 2001/18: no


For 1829/2003: See 2.1: "Central Commission for Biological Safety" (ZKBS) For 2001/18: See 2.1: "Central Commission for Biological Safety" (ZKBS)


For 1829/2003: Statements of the ZKBS are adopted by majority. Risk assessments for applications are finalized by the BVL, taking into account the statements from the ZKBS and the opinions from the other national authorities. For 2001/18: same as for 1829/2003


For 1829/2003: by written procedure For 2001/18: by written procedure

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: for 3 years (consecutive appointments are possible) For 2001/18: for 3 years (consecutive appointments are possible)

67


For 1829/2003: academics, others (no government officials) For 2001/18: academics, others (no government officials)


For 1829/2003: no For 2001/18: no If yes, are the declarations of interest renewed annually or per topic? - If yes, are they published and if yes, where? -



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: "Position statement of the ZKBS on the biological safety of antibiotic resistance genes in the genome of genetically modified plants", 1999, Central Commission for Biological Safety (ZKBS) http://www.bvl.bund.de/nn_1114960/EN/06__Genetic__Engineering/ZKBS/01__Allg__Stellungnahmen/01__generelleThemen/Antibiotikaresistenz.html (apllied for 1829/2003 and 2001/18 applications) "Ergänzende Stellungnahme der ZKBS zur Biologischen Sicherheit von Antibiotika-Resistenzgenen im Genom gentechnisch veränderter Pflanzen" ("Supplementing position statement on the biological safety of antibiotic resistance genes in the genome of genetically modified plants"), 2007, Central Commission for Biological Safety (ZKBS), http://www.bvl.bund.de/cln_007/nn_520770/DE/06__Gentechnik/093__ZKBS/01__Allg__Stellungnahmen/01__generelleThemen/biol__sich-Erg_C3_A4nzung.html (apllied for 1829/2003 and 2001/18 applications; available in German only) -

68


yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): mainly from EFSA and OECD If not, can you specify in which area and explain why: - Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. same


no


no


no

69



GREECE Questionnaire on GMO risk assessment in Europe BACKGROUND: This questionnaire is sent to each EFSA Advisory Forum member with the objective to collect information on the organisation, the approach and the procedures applied in the risk assessment of genetically modified organisms in each of the Member States of the European Union. A compilation of the information received from the members shall be made available and published as a working document for the meeting and shall be presented to the European Commission. NOTICE: To avoid overlap of information, please read through all the questions prior to starting to answer. 1 Your country’s organisation for GMO risk assessment GREECE 1.1 Which organisation(s) is(are) responsible for performing the GMO risk assessment under Regulation (EC) No 1829/2003? Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Α) Ministry of Rural Development and Food for GM food and feed Β) Hellenic Food Authority (EFET) for GM food produced from GM plants and microorganisms Is (are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes, both organizations are represented in the GMO EFSAnet. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): A) Ministry of Rural Development and food for GM feed: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment. B)EFET: molecular characterisation, compositional analysis, nutrition, toxicology, allergenicity

70

Number of applications assessed for which a national risk assessment report has been issued: No national risk assessment reports have been issued yet. EFET: Comments concerning a total of 20 dossiers have been submitted to EFSA extranet within the specified 3-month period. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? No national risk assessment reports have been issued yet. If yes, in which language and could you provide the reference or weblink if applicable? 1.2 Which organisation(s) is(are) responsible for performing the GMO risk assessment under Directive 2001/18/EC Part C (and Part B)? Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Part B: Ministry of Environment, Physical Planning and Public Works Part C: Ministry of Rural Development and Food Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): A) Ministry for the Environment, Physical Planning and Public Works: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment B) Ministry of Rural Development and Food: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: No national risk assessment reports have been issued yet. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?

71

1.3 In case the risk assessments mentioned under 1.1 and 1.2 are carried out by different organisations, how is the coordination of the work of these different risk assessment bodies organised? See footnote1 For 2001/18 directive: A) According to Article 8 of the Joint Ministerial Decision 38639/2017 FEK 1334/B (published in the Greek Government Gazette on 21-09-2005) which transposes Directive 2001/18/EC to Greek legislation, the Ministry for the Environment, Physical Planning and Public Works coordinates the Ministry of Rural Development and Food, the Ministry of Health, as well as other co-competent authorities such as the General Chemical State Laboratory in order to avoid negative effects on public health and the environment. For this reason, a five- member committee has been established, which is not functional yet. B) According to Article 16 of the Joint Ministerial Decision 38639/2017 FEK 1334/B (published in the Greek Government Gazette on 21-09-2005) which transposes Directive 2001/18/EC to Greek legislation, Ministry of Rural Development and Food coordinates the Ministry for the Environment, Physical Planning and Public Works, the Ministry of Health, as well as other co-competent authorities such as the General Chemical State Laboratory and the Hellenic Food Authority in order to avoid negative effects on public health from the placing on the market of GMOs as products or as product ingredients. For this reason, a seven-member committee has been established, which is not functional yet. 1.4 Can you briefly describe the interface between the risk assessor and the risk manager? Who ensures that the risk assessment and the risk management are appropriately linked for each application? For 1829/2003 applications: EFET: When an application for authorisation of a GM food is considered valid by EFSA, and is available for formal consultation through the commenting system of the GMO EFSAnet, the competent directorate, requests the Management Board (risk manager) to express its position on the application. The Management Board then, tasks the Scientific Council for Food Control (E.S.E.T) to perform risk assessments and to issue its opinion on the specific application. E.S.E.T. is a 10-member functionally independent advisory body of EFET’s Management Board tasked to perform risk assessments and to issue opinions. It consists of 1 expert on Veterinary Science, 4 experts on Food Technology, 1 expert on Nutrition, 1 expert on Microbial Biotechnology, 1 expert on Chemistry and 2 experts on Hygiene. In order to perform this task, E.S.E.T. is assisted by 8 working groups, one of which covers the GMO risk assessment. The opinions are then submitted to the Management Board (risk manager) for decision, which is then fed back to the competent directorate. 1 Please indicate “not applicable” in case the GMO risk assessments are carried out by the same organisation

72

For 2001/18 applications:

2 Your national risk assessment Experts Please specify for each question if the situation under Regulation 1829/2003 and under the Directive 2001/18 is different or not. If different, please specify the procedures under both legislations. 2.1 Can you indicate the number and the fields of competence of experts involved in the risk assessment per GMO application at national level? For 1829/2003: EFET: E.S.E.T. is assisted by 8 working groups which cover a wide range of food risks. The working group for GMOs consists of 6 members. The fields of expertise are chemistry, biology, veterinary science, food technology and plant biotechnology. For 2001/18: Due to the fact that the two committees concerning parts B and C are not functional so far, there are no specialized experts appointed to them. 2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: EFET: No For 2001/18: 2.3 Are the assessments carried out by a scientific Panel of national experts? If otherwise, please describe how? For 1829/2003: EFET: Yes (see Q 1.4 and 2.1) For 2001/18: 2.4 Are the assessments adopted by consensus? If otherwise, please describe. For 1829/2003: EFET: According to article 2 of the Procedural Manual of E.S.E.T., disagreements on matters of scientific nature should be resolved at E.S.E.T. level before the submission of the Opinion to the Management Board. For 2001/18: 2.5 Is the scientific advice provided by written procedure or through

73

discussion in meetings? For 1829/2003: EFET: Scientific advice is provided by written procedure and through discussion in meetings. For 2001/18: 2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: EFET: According to article 3 of the Procedural Manual of E.S.E.T., national experts are appointed for 3-year term. For 2001/18: 2.7 Are the national risk assessors employed as government officials and/or are they academics, consultants or others? For 1829/2003: EFET: National risk assessors are employed as government officials and/or academics and/or consultants For 2001/18: 2.8 Do you have Declarations of Interest of each national expert to safeguard your experts’ independence? For 1829/2003: EFET: Yes, all members of the E.S.E.T. and of the working groups sign a declaration of interest, confidentiality and independence. For 2001/18: If yes, are the declarations of interest renewed annually or per topic? EFET: Once, on appointment ……………………………………………………………………………………………………….. If yes, are they published and if yes, where? EFET: No

74

3 Your national risk assessment approach and methodology 3.1 Did your country issue its own risk assessment guidance document(s)? Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: No 3.2 Does your country rely on GMO risk assessment guidance from other organisations? If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): Yes - EFSA Guidance document for the risk assessment of genetically modified plants and

derived food and feed by the Scientific Panel on Genetically Modified Organisms (GMO) (May 2006)

- EFSA Guidance Document for the risk assessment of genetically modified plants containing stacked transformation events by the Scientific Panel on Genetically Modified Organisms (GMO) (The EFSA Journal (2007) 512, 1-5).

If not, can you specify in which area and explain why: Is there a difference under 1829/2003 or 2001/18 or is it the same? If different, please specify. 3.3 Are there any national activities related to the development for risk assessment methodologies in the area of GMOs? Please describe. 3.4 Which future developments in GMO risk assessment methodologies would your country envisage?

The development and validation of new profiling methods, such as DNA microarray technology, proteomics, and metabolomics for the identification and characterization of unintended effects, which may occur as a result of the genetic modification. 3.5 Do you wish to raise any particular issue on GMO risk assessment at the special EFSA Advisory Forum meeting?

- Recommendations about pre-release testing:

75

1. The use of new methods for the identification and characterization of unintended effects, which may occur as a result of the genetic modification.

2. Review of the limitations of current test methodologies for the safety testing of newly inserted proteins and of whole genetically modified foods.

- Recommendations about post market monitoring:

1. Post-marketing surveillance of the foods derived from genetically modified crops, even if the substantial equivalence to the conventional plant is confirmed (long term studies).

2. Post-marketing surveillance in case of the cultivation of a GM plant, especially if it is not a hybrid and the seed could be kept by the growers (stability of the insert through generations).

76



HUNGARY




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministry of Agriculture and Rural Development is the Competent Authority for GM plants and GM microorganisms. The Ministry of Environment and Water as well as the Ministry of Health also takes part in GMO risk assessment as specialised authorities. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Ministry of Agriculture and Rural Development and Ministry of Environment and Water are represented in the GMO EFSAnet. Hovewer, Ministry of Health has also access to GMO dossiers. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Ministry of Agriculture and Rural Development: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity Ministry of Environment and Water: molecular characterisations, environmental risk assessment Ministry of Health: toxicology, allergenicity, compositional analysis, nutrition. Number of applications assessed for which a national risk assessment report has been issued: No national risk assessment report has been published yet. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? National risk assessment reports are not available for the public.

77


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of Environment and Water - GM plants, micro-organisms, GM animals Ministry of Agriculture and Rural Development - GM plants, micro-organisms, GM animals Ministry of Health - GM plants, GM micro-organisms, GM animals Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Ministy of Environment and Water and Ministry of Agriculture and Rural Development are represented in the GMO EFSAnet. Hovewer, the Ministry of Health also has access to dossiers for commenting. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Ministry of Environment and Water - molecular characterisations, environmental risk assessment Ministry of Agriculture and Rural Development - molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity Ministry of Health - compositional analysis, nutrition, toxicology, allergenicity Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: Hungary has not received Part C application yet. No national risk assessment report has been published. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: In 2006/2007 the Hungarian National Competent Authority recived 18 application under Part B of Directive 2001/18/EC. The authorities carried out the risk assessment, a national report on the e.r.a. has not been published. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Hungary has not received Part C application yet, therefore no national risk assessment report has been issued yet. For Part B applications, SNIFs are sent to the EC database. Public information on authorized Part B releases are available under webpage www.biosafety.hu in Hungarian and English.


The Competent Authority (the Ministry of Agriculture and Rural Development) coordinates the work (it seeks the opinion from the other competent ministries, sets deadlines for comments and coordinates the finalisation of the risk assessment).


78


For 1829/2003 applications: Authorizing responsibility is shared by the Ministry of Agriculture and Rural Development, the Ministry of Health and the Ministry of Environment and Water. The Ministry of Agriculture is the national competent authority, the other two ministries takes part as specialised authorities by issuing an expert opinion in the authorisation process. The Ministry of Environment and Water is a special (veto) authority in giving an expert-opinion on the notification in environmental point of view. According to the law, an independent biotechnology committee gives opinion on the notifications. The Biotechnology Committee consists five delegates of the Hungarian National scientific Academy, one independent representative of each Minister, four delegates in common from civil organisations registered as for environmental purposes, and one delegate each in common by NGO-s for health conservation, biotechnology and consumer protection. Risk management measures are proposed by the Biotechnology Committee or the other ministries. For 2001/18 applications: Authorizing responsibility is shared by the Ministry of Agriculture and Rural Development, the Ministry of Health and the Ministry of Environment and Water. The Ministry of Agriculture is the national competent authority, the other two ministries takes part as specialised authorities by issuing an expert opinion in the authorisation process. The Ministry of Environment and Water is a special (veto) authority in giving an expert-opinion on the notification in environmental point of view. According to the law, an independent biotechnology committee gives opinion on the notifications. The Biotechnology Committee consists five delegates of the Hungarian National scientific Academy, one independent representative of each Minister, four delegates in common from civil organisations registered as for environmental purposes, and one delegate each in common by NGO-s for health conservation, biotechnology and consumer protection. Risk management measures are proposed by the Biotechnology Committee or the other ministries and are ordered in the final consent is issued by the Ministry of Agriculture and Rural Development.

79




For 1829/2003: 1 expert at the Ministry of Agriculture and Rural Development 2 experts at the Ministry of Environment and Water 1 expert at the Ministry of Health For 2001/18: 1 expert at the Ministry of Agriculture and Rural Development 2 experts at the Ministry of Environment and Water 1 expert at the Ministry of Health.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: No For 2001/18: No


For 1829/2003: Yes For 2001/18: Yes


For 1829/2003: Yes For 2001/18: Yes

80


For 1829/2003: Usually through discussion in the meeting For 2001/18: Usually through discussion in the meeting

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: CA members are employeed for an indeterminate period. Advisory members (Biotechonlogy Committee) are elected for 4 years. For 2001/18: CA members are employeed for an indeterminate period. Advisory members (Biotechonlogy Committee) are elected for 4 years.


For 1829/2003: The risk assessor is employeed as government official.. For 2001/18: The risk assessors are employeed as government officials.


For 1829/2003: Experts' indipendence is ensured by the general civil servant's regulation. For 2001/18: Experts' indipendence is ensured by the general civil servant's regulation. If yes, are the declarations of interest renewed annually or per topic? No If yes, are they published and if yes, where? No

81



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Risk assessment is carried out according to EC legislation and risk assessment guidelines. (Environmental risk assessment: Annex I. to Decree 142/2004. (IX. 30.) of the Ministry of Agriculture and Rural Development and the Ministry of Economy and Transport on certain rules of the gene technological activity in the field of agriculture and industry - applicable both for 1829/2003/EC and 2001/18/EC notifications).


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): Codex and EFSA guidelines are considered under the authorisation procedure. If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


No. However, we have national activities in the field of drafting which environmental impact studies should be carried out regarding first generation GM plants in the Pannon Biogeographical Region.


Hungary believes that there is a need for a detailed protocol in the EU on the methodology for environmental impact assessment and studies for each of the 9 different Biogeographical Region of the European Union. The protocol should refer to the environmental analytical studies, microbiological studies, botanical studies, animal studies, dietetic studies of vertebrate species and technological studies.

82


Yes, we suggest a discussion about the issue (mentioned under point 3.4) on a standarised protocol.

83



IRELAND




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Food Safety Authority of Ireland & Department of Agriculture, Food and Fisheries review EFSA risk assessments Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Advisory panel with variety of scientific expertise Number of applications assessed for which a national risk assessment report has been issued: None Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? N/A


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Environmental Protection Agency Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes

84

Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Environmental risk assessment and has access to experts with disciplines mentioned above. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: None Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 6 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? It is available in English for one of above consents. http://www.epa.ie/whatwedo/licensing/gmo/release/partc/trial/


Informal meetings


For 1829/2003 applications: EFSA risk assessments used by risk managers For 2001/18 applications: For deliberate releases into the environment, the risk assessment is carried out by the notifier in accordance with the provisions of Directive 2001/18/EC. In the case of part B releases (field trials), the national competent authority (CA) where the deliberate release takes place evaluates the notification including the risk assessment to ensure its compliance with the GMO regulations and Directive 2001/18/EC. For Part C releases the evaluating CA carries out the assessment with inputs from all EU MS CA's and from the EFSA.


85




For 1829/2003: Competent Authority relies on EFSA risk assessments which are reviewed by a panel of experts that include plant biologists, molecular biologists, microbiologists and others For 2001/18: The Competent Authority seeks the advice of the statutory national Advisory Committee on GMOs. The Committee is appointed for a three-year term. The Committee consists of 14 members nominated by Government and non-Government organisations (NGOs). Committee members have expertise in the following: plant molecular biology, microbiology, ecology, legal affairs etc



For 1829/2003: EFSA carries out risk assessment which is reviewed by the Competent Authority expert panel For 2001/18: Assessments are carried out by competent authority with advice from the GMOAC and other experts from government departments as applicable.


For 1829/2003: Competent Authority considers the advice of expert panel in forming an opinion For 2001/18: It is the competent Authority who makes the final decisions in relation to notifications and

86

dossiers having regard to advice from GMOAC and its own experts.


For 1829/2003: Both For 2001/18: Both

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Five years renewable For 2001/18: Membership to Advisory Committee is for 3 years but a person can serve longer if re-appointed.


For 1829/2003: Voluntary experts from Government bodies or academia For 2001/18: They are usually officers from government departments, state agencies or members of NGO's and academia.


For 1829/2003: Yes For 2001/18: Yes. Each expert is requested to sign a declaration of interest form to safeguard the expert's independence. If yes, are the declarations of interest renewed annually or per topic? In the case of the Advisory committee it is done after appointment. Other experts/consultants it is done on a case by case basis. If yes, are they published and if yes, where? Not

87



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: No


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): Yes - EFSA If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


N/A


GM animals and newer types of GM crops producing medicinal/pharmaceutical type products


No

88



ITALY




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministero della Salute (Ministry of Health) Ministero dell' Ambiente e della Tutela del Territorio e del Mare (Ministry of Environment), as per article 6 (para 4 and 5), article 18 (para 4 and 5) article 44 of 1829/2003, that deals with conformity in respect to Cartagena protocol. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): molecular characterisations, compositional analysis, toxicology, allergenity, environmental risk assessment. Number of applications assessed for which a national risk assessment report has been issued: 1 Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? no


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministero dell'Ambiente e della Tutela del Territorio e del Mare (Ministry of Environment) for GM

89

plants, micro-organisms and/or GM animals Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No because we receive the dossiers under Dir. 2001/18 directly from the European Commission Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): molecular characterisations,compositional analysis, toxicology, allergenity, environmental risk assessment. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: zero Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: zero Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? yes italian and english in the web site http://bch.minambiente.it


The work on GMO's risk assessment under Directive 2001/18 is carried out by the IEC (Interministerial Evaluation Commission); members of Ministry of Health are Members of the IEC; The work on GMO's risk assessment under Regulation 1829/2003 is carried out by the Ministry of Health; Commission for the risk assessment include Members of the Ministry of Environment.


For 1829/2003 applications: All the Institution belonging to the Ministry of Health, such as National Institute of Health (ISS) and National Reference Laboratory for GMOs detection (CROGM) cooperate with meetings and reports with the Ministry of Health For 2001/18 applications: In first time the IEC develops the decision making in second time the IEC informs the Regional Competent authorities for to implement the general surveillance


90




For 1829/2003: The number is variable according to the area of interest and the complexity of the issue For 2001/18: 20

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: The public availability depends on the Institution for which the expert is acting For 2001/18: yes italian and english in the web site http://bch.minambiente.it


For 1829/2003: yes For 2001/18: national experts


For 1829/2003: yes For 2001/18: yes


For 1829/2003: Discussion in meetings

91

For 2001/18: In first time discussion in meetings in second time the scientific advice provided by written paper



For 1829/2003: The risk assessors are both experts from governmental institutions, academics and consultants For 2001/18: yes


For 1829/2003: The safeguard of the experts' independence is guarantee by the decree of nomination For 2001/18: yes If yes, are the declarations of interest renewed annually or per topic? no If yes, are they published and if yes, where? no



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: For 1829/2003: no For 2001/18: annex II for Directive 2001/18/CE

92

annex III for Cartagena Protocol on Biosafety


yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA; OECD; CODEX; ENGL Secretariat of the CBD for the Cartagena Protocol on Biosafety If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. yes there is difference in particular under 1829/2001 the prevalent interest areas are food/feed and processing. Under 2001/18/CE the prevalent interest areas are field and cultivation


Research is conducted both at national and at european level such as arrays methodology and exposure assessment of GMOs


Omics techniques(metabolomics, proteomics, genomics) ; long terms consumption studies


No

93



LATVIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Foos Center of the Food and Veterinary Service Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Food Center of the Food and Veterinary Service in cooperation with the Council of Surveillance of Genetically Modified organisms and the Scientific Expert Committee - molecular characterisations, compositional analysis, nutrition, allergenicity, toxicology, environmental risk assessment Number of applications assessed for which a national risk assessment report has been issued: None yet. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? No national risk assessment has been issued yet.


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Food Center of the Food and Veterinary Service in cooperation with the Scientific Expert Committee - GM micro-organisms and/or GM animals;

94

Food Center of the Food and Veterinary Service in cooperation with State Environmental Service and the Scientific Expert Committee - GM plants Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Food Center of the Food and Veterinary Service, the Scientific Expert Committee and the Council of Surveillance of Genetically Modified Organisms - environmental risk assessment, toxicology, compositional analysis, molecular characterisation;nutrition, allergenicity; State Environmental Service - environmental risk assessment, toxicology, molecular characterisations Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: None yet. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: none yet Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? None issued yet, thus unavailable. But if there will be any, it will be published in www.pvd.gov.lv


Food and Veterinary Service after receiving an application in accordance with Directive 2001/18/EC and Regulation 1829/2003/EC forwards it for the risk assessment to its subbordinate body - Food Center. Food Center examines the application in collaboration with team of experts - Scientific Expert Committee and the Council of Surveillance of Genetically Modified Organisms - and with State Environmental Service either in an electronical or physical working group prepares a safety risk assessment. Food Center compiles the assessment and sends it back to the Food and Veterinary Service or Ministry of Agriculture for risk management activities.


95


For 1829/2003 applications: Ministry of Agriculture requests a risk assessment from Food and Veterinary Service (FVS) on applications submitted from other EU Member States to European Commission and EFSA. In cases of GMO applications at national level, they are submitted directly to Food and Veteinary Service where Food Centre together with Scientifi Expert Committee is responsible for the risk assesment of the submitted application. Food Center in cooperation with the Scientific Expert Committee and the Council of Surveillance of Genetically Modified Organisms the risk assessment on the specific application. FVS in cooperation with the Ministry of Agriculture as risk managers adopts the opinion. For 2001/18 applications: Ministry of Agriculture requests risk assessment from the Food and Veterinary Service (FVS) on applications submitted from other EU Member States to European Commission and EFSA. In cases of GMO applications for Latvian market, they are submitted directly to Food and Veteinary Service where Food Centre together with the Scientific Expert Committee is responsible for the risk assesment of the submitted application. In Food Centre of FVS the risk assessmnent is carried out in cooperation with Scientific Expert Committee, the Council of Surveillance of Genetically Modified Organisms and State Environmental Service. FVS in cooperation with the Ministry of Agriculture as risk managers adopts the opinion.




For 1829/2003: Microbiology, biology, molecular biology, food science, food chemistry, chemistry, agriculture, nutrition, genetics, selection, biotechnology, environment, economy. For 2001/18: Microbiology, biology, molecular biology, food science, chemistry, agriculture, genetics, selection, biotechnology, environment, economy.

96

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: Partially. Currently some of them- at their representing institutions. For 2001/18: Partially. Currently some of them- at their representing institutions.


For 1829/2003: Yes.See above. For 2001/18: Yes. See above


For 1829/2003: Yes. For 2001/18: Yes.


For 1829/2003: Both, depending on situation. For 2001/18: Both, depending on situation.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Not teminated. For 2001/18: Not terminated.


For 1829/2003: Some are governmental experts, most are academics. For 2001/18:

97

Some are governmental experts, most are academics.


For 1829/2003: Not yet. For 2001/18: Not yet. If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Under development


Yes- If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): FAO/WHO Codex, EFSA. If not, can you specify in which area and explain why: - Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. Will be differet on some issues.


Ministry of Agriculture is responsible for developing methodology of GMO risk assessment in Latvia.Not approved and developed yet.

98


Common appraoch where possible


?

99



LITHUANIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministry of Environment of the Republic of Lithuania is the competent authority for GMO state management in Lithuania. MoE works together with Ministry of Health, Ministry of Agriculture and the State Food and Veterinary service. MoE has established GMO's Experts Committee to assess risk of GMO. It is the national consultative, scientific committee for risk assessment of GM plant, GM microorganisms, GM animals. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The GMO Experts committee is a consultative advisory body with a clear task to act as advisor to the Competent Authority giving an advice in handling and scrutinizing notifications and requests for the risk assessment of contained use, experimental releases of GMOs at national level, deliberate release into environment and/or placing to the market of GMOs. This committee consists of 11 scientists from different scientific areas: genetic, microbiology, biochemistry, health, agriculture, zoology, forestry, geology, veterinary science. Number of applications assessed for which a national risk assessment report has been issued: - Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? http://gmo.am.lt, language - lithuanian

100


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of Environment of the Republic of Lithuania is the competent authority for GMO state management in Lithuania. MoE works together with Ministry of Health, Ministry of Agriculture and the State Food and Veterinary service. MoE has established GMO's Experts Committee to assess risk of GMO. It is the national consultative, scientific committee for risk assessment of GM plant, GM microorganisms, GM animals. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The GMO Experts committee is a consultative advisory body with a clear task to act as advisor to the Competent Authority giving an advice in handling and scrutinizing notifications and requests for the risk assessment of contained use, experimental releases of GMOs at national level, deliberate release into environment and/or placing to the market of GMOs. This committee consists of 11 scientists from different scientific areas: genetic, microbiology, biochemistry, health, agriculture, zoology, forestry, geology, veterinary science. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: - Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 4 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? http://gmo.am.lt, language - lithuanian


not applicable


For 1829/2003 applications: MoE and Ministry of Health. For 2001/18 applications: MoE and Ministry of Health, Ministry of Agriculture.


101




For 1829/2003: The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human and the environment. For 2001/18: The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human and the environment.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: Yes, website https://bch.biodiv.org For 2001/18: Yes, website https://bch.biodiv.org


For 1829/2003: Yes For 2001/18: Yes


For 1829/2003: Yes For 2001/18: Yes


For 1829/2003: The scientific advise is provided by written procedure and dicussion in meetings. For 2001/18:

102

The scientific advise is provided by written procedure and dicussion in meetings.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: The national experts committee adopted by the order No. 198 of the Minister of Environment on April 25, 2003. For 2001/18: The national experts committee adopted by the order No. 198 of the Minister of Environment on April 25, 2003.


For 1829/2003: The national risk assessors are employed as scientists-consultants. For 2001/18: The national risk assessors are employed as scientists-consultants.


For 1829/2003: No declarations For 2001/18: No declarations If yes, are the declarations of interest renewed annually or per topic? - If yes, are they published and if yes, where? -



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: 1. The Order on Regulation of Risk Assessment on GMOs (adopted by the order No. 681/689/525/753 of the ministers of Environment, Health and Agriculture, and the Director of State Food and Veterinary Service); 2. Law on Genetically Modified Organisms, June, 2001 (No. IX-375) legally came into force since 31 of December 2002; 3. Regulation on GMOs Deliberate Release into the Environment, Placing on the Market was adopted by the order No. D1-225 of the minister of Environment on April 29, 2004; 4. Order on Regulation on Contained Use of Genetically Modified Micro-organisms was adopted by the order

103

No. 413 of the minister of Environment on August 4, 2003; 5. Order on Criteria for Genetically Modified Micro-organisms Classification was adopted by the trilateral agreement No. D1-693/V-954/B1-1107 of the Minister, the Minister of Health and the Director of State Food and Veterinary Service on December 28, 2004; 5. Order on Regulation on Public Information and Participation in Issuing of Consents for Use of GMos adopted by the order No. 299 of the Minister of Environment on June 11, 2003; 6. Establishing of GMOs Steering Committe adopted by the order No. 602 of the mInister of Environment on December 18, 2001; 7. Establishing of GMos Experts Committee adopted by the order No. 198 of the Minister of Environment on April 25, 2003.


If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): Yes, EFSA If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


The Ministry of Environment finances a projet "Risk assesment of GM plants, methodology and conclusions".


To participate for GMO risk assessments in future projects.


-

104



MALTA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Foodstuffs, Chemicals and Cosmetics Directorate, Malta Standards Authority Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Compositional analysis, nutrition, toxicology Number of applications assessed for which a national risk assessment report has been issued: 0 Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? N/A


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Malta Environment and Planning Authority (MEPA) - for all above mentioned fields Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations,

105

compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): All the above through the expertise within the Biosafety Co-ordinating Committee within MEPA Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: No applications received nationally Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: No applications receiced nationally Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? If we were to have an application they would be available on the MEPA GMO website Http://www.mepa.org.mt/environment/index.htm?GMOs/mainpage.htm&1


Through the Biosafety Co-ordinating Committee since all organisations are represented within this Committee. http://mepaweb/environment/GMOs/committee.htm


For 1829/2003 applications: The Maltese Food Safety Commission For 2001/18 applications: The Biosafety Co-orinating Committee


106




For 1829/2003: Molecular Biology, Toxicology, Food Safety For 2001/18: Molecular Biology, Genetics, Biosafety, Entomology, Agriculture, Chemical and Biological Safety, Biodiversity Conservation and Management, Public Health, Food Safety, Veterniary Services, Fisheries.



For 1829/2003: The expertise of the Biosafety Co-ordinating Committee is used after that a preliminary analysis is carried out. For 2001/18: Yes the Biosafety Co-Ordinating Committee


For 1829/2003: yes For 2001/18: yes

107


For 1829/2003: Through discussion in meetings For 2001/18: Both



For 1829/2003: Government officials For 2001/18: Government officials and consultants


For 1829/2003: Yes For 2001/18: Yes If yes, are the declarations of interest renewed annually or per topic? per topic If yes, are they published and if yes, where? no

108





Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


No


Standard harmonised procedures for all EU applications


None

109



THE NETHERLANDS




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” The Dutch portal for European GMO market applications (part of the GMO office, in Dutch language: Bureau GGO - loket functie voor Nederlandse GGO-aangelegenheden, wettelijke toelating) is situated at the National Institute of Public Health and the Environment (RIVM) in Bilthoven and is established on January 2004 by three ministries, responsible for food safety (Ministry of Health, Welfare and Sport), feed safety (Ministry of Agriculture, Nature and Food Quality) and environmental safety (Ministry of the Environment) of gmo’s. For further information on the portal and procedures: www.vrom.nl/ggo-vergunningverlening under “loket ggo markttoelatingen”. The Dutch portal for European GMO market applications coordinates the risk assessment for the Netherlands for the three ministries involved: Ministry of Health, Welfare and Sport (food safety), Ministry of Agriculture, Nature and Food Quality (feed safety) and Ministry of Spatial Planning, Housing and the Environment (Environmental Safety). There are two research institutions of which experts advise the Ministries based on dossiers: 1) National Institute for Public Health and the Environment - Centre for Substances and Integrated Risk Assessment (SIR) at Bilthoven (food safety); 2) RIKILT-Institute of Food Safety - Safety & Health business unit at Wageningen (feed safety) and, There is one advisory body that advises the Ministries based on dossiers: 1) Commission on Genetic Modification (COGEM) at Bilthoven (environmental safety). Independently, the Office for Risk Assessment (Bureau Risicobeoordeling) of the Food and Consumer Product Safety Authority (VWA) provides to the Ministries both solicited and unsolicited

110

advise on possible threats concerning GMOs (food/feed safety) based on, for instance, EFSA opinions, (new) scientific findings etc., i.e. no dossier assessment. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No, the Office for Risk Assessment of the Food and Consumer Product Safety Authority (VWA) Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): RIKILT (Institute of food safety in Wageningen): feed safety including compositional analysis, toxicology and molecular characterisations SIR (Center for Substances and Risk assessment at the National Institute of Public Health and the Environment (RIVM) in Bilthoven): food safety including nutrition, toxicology, allergenicity COGEM in Bilthoven: molecular characterisations, environmental safety GMO office in Bilthoven: molecular characterisation, environmental safety Office for Risk Assessment VWA in the Hague: food/feed safety including compositional analysis, nutrition, toxicology, allegenicity Number of applications assessed for which a national risk assessment report has been issued: All valid applications on efsanet have been assessed by RIKILT, SIR/RIVM, GMO office and COGEM, whereas the Office for Risk Assessment (VWA) occasionally provides an advise to the Ministries based on a EFSA opinion or a request from the Ministries of Agriculture or Health, or EFSA. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? The environmental safety advises from COGEM are publicly available: www.cogem.net (Dutch and English language) Risk assessment reports and advises of the Office for Risk Assessment (VWA) are publicly available: www.vwa.nl (Dutch language, sometimes also in English)


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of Housing, Spatial Planning and the Environment. The GMO office at RIVM that handles all applications for this Ministry. The advisory body COGEM. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): GMO office, COGEM: molecular characterisation and environmental risk assessment Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: - Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: - Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?

111

Yes in Dutch and English: www.vrom.nl/ggo-vergunningverlening


For 1829/2003 the Dutch Portal (part of the GMO Office: the Food/Feed GMO Counter) coordinates the work of the risk assessment bodies: RIKILT, SIR/RIVM, COGEM


For 1829/2003 applications: The target group of risk managers comprises the Dutch national and European authorities involved with the regulatory approval and risk analysis of GMOs and novel foods and novel food ingredients. These groups are provided with expert advice on safety of GMOs for food and animal feed purposes and novel foods. The interface between the Dutch national (Ministries, VWA) and European authorities (Commission, EFSA) and the expert risk assessors of COGEM, RIKILT and SIR/RIVM is established through the Dutch Portal (the Food/Feed GMO Counter). This is done on a case-by-case basis within the frame of the regulatory approval procedures for the market admission of GMOs and novel foods in the European Union (EU), and also in response to ad hoc questions from these authorities (risk managers). Through the Dutch Portal it is ensured that advice is linked to the European Food Safety Authority's (EFSA) Scientific Panel on GMOs; to the Dutch Ministry of Agriculture, Nature, and Food Quality, the GMO Office of the Dutch Ministry of Environment, the Dutch Centre for the Evaluation of Medicines and other national and European authorities. Independently, the Food and Consumer Product Safety Authority (VWA) provides to the Ministries and EFSA both solicited and unsolicited advise on the food/feed safety of GMOs. In this case, the interface is made up by the Office for Risk Assessment of which the independent implementation of this task is regulated by the Independent Risk Assessment Act of 2006. Part of the VWA is the inspectorate. For 2001/18 applications: The GMO office handles the application and the Ministry gives the permit. Part of the Ministry is the inspectorate.


112




For 1829/2003: food safety: SIR/RIVM (two (2) experts) feed safety: RIKILT (three (3) experts) environmental safety: COGEM (subcommittte on Agriculture: twelve (12) members; subcommittee on Medical and Veterinary Aspects: twelve (12) members and subcommittee on Ethics and Social Aspects: twelve (12) members) For 2001/18: environmental safety: COGEM (see above)



For 1829/2003: yes for the environmental part (COGEM is a scientific panel of national experts). no, the food and feed safety is assessed by individual experts from the research institutions RIVM (SIR) and RIKILT, however, depending on the issue (dossier) at stake, SIR/RIVM and RIKILT adopt the risk assessments by consensus For 2001/18: yes for the environmental assessments (COGEM, see above)


For 1829/2003: yes For 2001/18: yes

113


For 1829/2003: written procedure For 2001/18: written procedure

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: RIKILT: three academics with a permanent institute's appointment SIR (RIVM): two academics with a permanent institute's appointment COGEM: panel members are appointed for 4 years For 2001/18: COGEM: panel members are appointed for 4 years


For 1829/2003: SIR (RIVM), RIKILT: academics employed as semi-government officials For 2001/18: COGEM: academics not employed as government officials


For 1829/2003: SIR (RIVM): no RIKILT: no, but on the other hand, there are declarations through EFSA's GMO panel i.e. chair and active members of working groups COGEM: yes For 2001/18: yes, through COGEM If yes, are the declarations of interest renewed annually or per topic? SIR/RIVM and RIKILT: no COGEM: yes annually If yes, are they published and if yes, where? no

114



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: no


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD, FAO/WHO, Codex, COGEM (environment) If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. no


No, as yet there are no national projects or programmes in field risk assessment, however, there is a DG-Research co-sponsored project SAFEFOODS (FP6) coordinated by RIKILT (e.g. unintended effects) On the other hand, the Dutch government (e.g. Ministry of Spatial Planning, Housing and the Environmemt (VROM) and COGEM) invests in research to improve GM detection methods including approaches for non-authorised species.


Risk assessment of (farm) animal biotechnology and GM plants for active pharmaceutical use/components; Harmonisation of the impact assessment of GM plants on non-target organisms (NTOs) between various countries and developing guidance for applicants to allow the selection of (indicator) organisms and proper methods

115


Harmonisation of more uniform approaches to the design and analysis of animal feeding trials, and in particular for appropriate statistical analysis of data; risk asessment of animal biotechnology; Stacking of genes; Novel types of GM plants such as pharma-plants; Animal biotechnology.

116



NORWAY




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Norwegian Scientific Committee for Food Safety (VKM) Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): VKM has expertise in all areas listed Number of applications assessed for which a national risk assessment report has been issued: 24 Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, they are available at www.vkm.no, in Norwegian with a summary in English


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: VKM Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations,

117

compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): VKM has expertise in all areas listed Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 2 (VKM has had this responsibility since april 2007) Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 2(VKM has had this responsibility since april 2007) Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, they are available at www.vkm.no, in Norwegian with a summary in English


Not relevant


For 1829/2003 applications: Risk management: Norwegian Food Safety Authority (MT) and Directorate for Nature Management (DN) are responsible for risk management witin health risk and environmental risk, respectively For 2001/18 applications: DN is a risk manager. The procedure is that DN requests a risk assessment from VKM. VKM is responsible for submitting comments during the three-months consultation period. The risk managers also take other factors into consideration in preparing their posistions.


118




For 1829/2003: The GMO Panel of VKM consists of 12 members. It covers all fields of competence mentioned in question 1.1. The panel is resonsible for the risk assessments. For 2001/18: The GMO Panel of VKM is also responsible for these risk assessments. In addition 2 extra experts (expertise in plant protection products, ecology and environmental issues) take part in the ERA.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: www.vkm.no For 2001/18: www.vkm.no


For 1829/2003: yes For 2001/18: yes


For 1829/2003: Yes as a rule, but in case of different scientific views this is also included in the published opinion For 2001/18: Yes as a rule, but in case of different scientific views this is also included in the published opinion

119


For 1829/2003: Preferably in meetings, but sometimes written procedure is necessary in order to meet time limits For 2001/18: Preferably in meetings, but sometimes written procedure is necessary in order to meet time limits



For 1829/2003: Majority are academics, some are government officials For 2001/18: Majority are academics, some are government officials


For 1829/2003: yes For 2001/18: yes If yes, are the declarations of interest renewed annually or per topic? Both annually and per topic If yes, are they published and if yes, where? Yes: www.vkm.no

120



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Yes, from 1998 to 2002. From 2004 the EFSA Guidance document of the Scientific Panel on Genetically Modified Organisms are applied


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD, FAO/WHO (Codex) If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. No


No


Nothing at present


Assessment of plant protection products in relation to ERA. I Norway ERA is also assessed in a societal cost-benefit context.

121



PORTUGAL




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Portuguese Food Safety and Economic Authority (ASAE) Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Number of applications assessed for which a national risk assessment report has been issued: Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Directive 2001/18/EC, of 12 March, was transposed into national law by Decree-law nº. 72/2003, of 10th April, concerning the deliberate release into the environment of genetically modified organisms and the placing on the market of GMOs as or in products. According to the above legislation framework, the national competent authority for risk assessement

122

is Portuguese Environment Agency, tecnically supported by Direcção Geral de Saúde and Direcção Geral de Agricultura e do Desenvolvimento Rural. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes the Portuguese Environment Agency is represented in the GMO EFSAnet. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): As referred above, Portuguese Environment Agency undertakes the environmental risk assessment supported by Direcção Geral de Saúde and Direcção Geral de Agricultura e Desenvolvimento Rural. The required areas of expertise are gathered among the referred authorities. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: None, because it was not received untill the present moment, any notification under Part C. However, the Portuguese Environmental Agency makes comments during the risk assessment process (Directive 2001/18/EC) of notifications submited in other Member-states. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: Since the entry into force of the Directive 2001/18/EC, Portugal has received 11 notifications under Part B, of which only one final national risk assessment report was issued. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? The national risk assessement reports are only available for the public if they are requested. The reports are in Portuguese.


In Portugal, several restructurations on the Public Administration have been carried out recently, and responsibilities on GMO risk assessment, that used to be assign to organisations that have been extinguished, are now assigned to the recently established (2006,2007) organisations above mentioned. These two organisations have had their first meeting in July, and since then they are in close contact.


For 1829/2003 applications: GMO risk assessment and GMO inspection are together in the same organisation For 2001/18 applications:


123




For 1829/2003: For 2001/18: Regarding Directive 2001/18/EC the experts involved in risk assessment have the following competences: - environmental risk assessment 2 experts - nutrition, toxicology and allergenicity 1 expert

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: For 2001/18: The CV of the national experts are not publicly available.


For 1829/2003: ASAE has a Scientific Committee that will set up, in the near future, a Scientific Panel on GMO. For 2001/18: Regarding Directive 2001/18/EC, the assessments are not carried out by a scientific Panel of national experts. The risk assessments are carried out by the authorities already referred in 1.2.


For 1829/2003: For 2001/18:

124

In what concerns to directive 2001/18/EC, the Portuguese Environmental Agency can decide independently of the position adopted by the consulted entities.


For 1829/2003: For 2001/18: Concerning Directive 2001/18/EC, the most common procedure is a written consultation. However, when required, discussion is held in meetings (this has occurred more frequently during the assessment procedure of notifications Part B).

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Yet to be defined For 2001/18: Considering the answers provided previously this question is not applicable.


For 1829/2003: Yet to be defined For 2001/18: The national risk experts responsible at the moment, for the risk assessment, are government officials. However, when needed, the authorities are supported by external entities (national laboratories).


For 1829/2003: For 2001/18: Considering the answers provided previously this question is not applicable.However, if an external entity is needed, the contract will have a clause refering to the expert´s independence. If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?

125



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: Regarding Directive 2001/18/EC, it was not issued any additional national guidance document. The Portuguese Environment Agency has put available some guidance on the information format regarding notifications Part B.


Yet to be defined If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): In what concerns the Directive, we rely on the GMO risk assessment guidance notes from European Commission Decision n. º 623/2002, of 24th July, that establishes guidance notes on the objective, elements, general principles and methodology of the environmental risk assessment. We also rely on the Guidance document of the Scientific Panel on GMO for the risk assessment of genetically modified plants and derived food and feed published by EFSA. If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


At national level, there have been some national research projects on GMO but as far as we know there are no development of risk assessment methodologies.


In what concerns to GMO risk assessment methodologies, Portugal would envisage the development of a more detailed and defined approach for risk assessment.


Issue of guidance on the new technologies (GM trees, GM fish, etc).

126



ROMANIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” The GMO Panel of the Scientific Councill of National Sanitary Veterinary and Food Safety Authority (ANSVSA) - responsible for GM food and feed risk assesment Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. 2 designated persons from ANSVSA submitted, at the beginning of 2007, applications to gain acces to EFSAnet and are still waiting for a reply from EFSA Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The GMO Panel of the Scientific Councill is composed by the best romanian scientists with different expertise that covers all the fields named above. Number of applications assessed for which a national risk assessment report has been issued: Since may 2004 (when it was established the Scientific Councill) untill 2006, there were assesed 15 aplications for field testing of GM soybean, GM maize and GM plum under national legislation, and were issued scientific opinions. Since january 2007 no application was received, but there were issued scientific opinions on the safety of 3 types of GM maize and 1 of GM rice, at the request of ANSVSA. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? -

127


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: scientific risk assessment is done by the Biosafety Commission and technical aspects related to the dossier are covered by the National Environment Protection Agency (NEPA) in close collaboration with the appropriate involved authorities Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. no Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): at the moment the Biosafety Commission is under organization and we are expecting that over 2 month it should be fully operational Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: during 2007 - no applications under part C Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 13 applications, and ERA was done by the old Biosafety Commision wich was dissolved et the beginning f July 2007 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? no


Within the Interministry Committee that comprise the representatives af all authorities involved in food safety, animal health and environment protection, there is a permanent exchange of information. The scientific information obtained from those 2 RA bodies named above is exchanged also. According to the Protocol of Cooperation between the Authorities with responsibilities in the field of GMO, the information is regulary exchangend on a weekly basis and when necessary.


For 1829/2003 applications: The ANSVSA risk managers are providing the necessary data to the GMO Panel risk assesors. The meetings of GMO Panel are assisted by risk managers. For 2001/18 applications:


128

it is the task of National Environment Protection Agency in close collaboration with the involved authorities. The evaluation is done for environment risk, human health risk, animal health risk, plant health risk, consumer protection




For 1829/2003: GMO Panel of the Scientifc Council - composed by 7 independent experts from scientific organisations, having as background molecular biology, toxicology, agronomy, veterinary medicine, human medicine. For 2001/18: only after the Biosafety Commision nomination

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: since September 2007 it has begun the publishing of the CVs. Untill mid October all CVs will be publicly available on the ANSVSA web-site. For 2001/18: only after the Biosafety Commision nomination


For 1829/2003: Scientific Councill of ANSVSA carries out risk assesments whenever is requested by ANSVSA. All the documents and files necessary for risk assesment of one type of GMO are gathered by ANSVSA responsibles and aprox. 2 weeks prior the meeting of Scientific Councill are diseminated, together with the technical analisys, to the Members of GMO Panel which analise those documents, studies, plans etc. and after the discussions in the Panel is issued a scientific opinion For 2001/18: yes


For 1829/2003: Consensus

129

For 2001/18: two third of majority


For 1829/2003: The scientific advice is provided in written procedure during the Panel meeting, document undersigned by all Members. For 2001/18: it will be by written procedure and discussion in meetings

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: Unlimited For 2001/18: it will be for 4 years


For 1829/2003: They are independent (members of Romanian Academy, University Professors, Scientists). For 2001/18: not decided yet


For 1829/2003: Yes For 2001/18: yes If yes, are the declarations of interest renewed annually or per topic? yes they should be renewed annually and they shoul declaire in the beginning of each meeting if there exists a conflict of interests If yes, are they published and if yes, where? no




130


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, Codex Alimentarius, FAO; OECD - under Directive 18/2001 If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


For 1829/2003, ANSVSA is in process of increasing the role of science in the risk assesment methodology. This will be made by finding sources for financing and raise the awarness of scientific medias in the issue of GMOs.


As a medium term strategy for cooperation with EFSA, Romania is able to envisage the EFSA risk assesment strategy


if necessary

131



SLOVAKIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Food Research Institute in Bratislava Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Food Safety Number of applications assessed for which a national risk assessment report has been issued: None Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? No


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of Environment of the Slovak Republic - for GMMOs, plants and animals, used in contained use regregime and released to the environment for trials Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes

132

Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Environmental risk assessment Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 0 Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 1 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, in Slovak language, www.enviro.gov.sk


not applicable


For 1829/2003 applications: Risk assessment is made by independent expert of Food Research Institute, which finally gives recccomendation to Ministry of Agriculture of SR - which is decision maker (and risk management). For 2001/18 applications: Risk assessment is made by independent expert of Slovak Biosafety Committee, which finally gives recccomendation to Ministry of Environment of SR, which is decision maker (and risk management).


133




For 1829/2003: 3 - molecular chcaracteriasation, nutrition, toxicology For 2001/18: 15 experst for Risk Assessment of GMMOs, for GM plants, for GM animals, for environment and for human health



For 1829/2003: No For 2001/18: by Slovak Biosafety Committee serving as the Advisory body for Ministry of Environment


For 1829/2003: Yes For 2001/18: Yes - via voting


For 1829/2003: written procedure

134

For 2001/18: in written form after the discussion

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: No time limit For 2001/18: No time limit


For 1829/2003: academic consultant For 2001/18: academic and research consultants


For 1829/2003: No For 2001/18: No If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: 1829/2003 - EFSA Quidance documents, 2004 for plants, 2006 for microorganisms 2001/18 guidance is "in force" by the Act No. 151/2002 Coll. on use of genetic technologies and GMOs, as ammended, based on the 2001/18. Unformal guidance was published as brochure "Guidance of risk assessment process of gene technics and GMOs", second issue 2007, Ministry of Environment and Slovak Academy of Science/ Dr. Danka Valkova and Prof. Jan Turna; applied for 2001/18.

135


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): - 1829/2003 - we consider OECD Consensus documents, EFSA opinions and also Codex quidelines If not, can you specify in which area and explain why: - 2001/18 - each Risk assessment made by other organisations, is assessed by rules of Ministry of Environmentagain Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify.


No


Simplified procedures for using of GMOs with long time and with safe use


No

136



SLOVENIA




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” Ministry of Health (MH; Competent Ministry(CM) for GM food) and Ministry of Agriculture, Forestry and Food (MAFF; CM for GM feed). In case of need the CMs could consult Agricultural Institute of Republic Slovenia (AIRS) and/or National Institute of Biology (NIB) and/or Institute of Public Health (IPH) as well as Scientific Committee for the Deliberate Release of GMOs into the Environment and Placing Products on the Market (SCDR). Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Genetics, biology, agriculture, veterinary sciences, biochemistry and molecular biology, microbiology, and medicine. Number of applications assessed for which a national risk assessment report has been issued: / Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? /

137


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Ministry of the Environment and Spatial Planning (MESP) with their Scientific Committee for the Deliberate Release of GMOs into the Environment and Placing Products on the Market (SCDR). Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Genetics, biology, agriculture, veterinary sciences, biochemistry and molecular biology, microbiology, and medicine. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: Slovenia has never been up to now a lead country. Since, becoming a member of EU we assesed all notification. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: There are no field trials, and therefore no current activity in this field. Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, they are publicly available. In Slovenian lenguage. Furthermore, under the Management of GMOs Act (MGMOA) the Slovenian Scientific Committee for the Deliberate Release of GMOs into the Environment and Placing Products on the Market (SCDR) prepares an annual report (http://www.biotechnology-gmo.gov.si/).


The Slovenian Scientific Committee for the Deliberate Release of GMOs into the Environment and Placing Products on the Market (SCDR) providing expert opinions which is than coordinated and reconciliated among responsible Ministries. The comprehensive position could be then forwarded to the EC.


138


For 1829/2003 applications: The AIRS, NIB, IPH and SCDR could make recommendations for risk asessment measures but the MH in case of GM food and MAFF in case of GM feed decides on risk management measures. For 2001/18 applications: SCDR could make recommendations for risk asessment measures but the MESP in case of environment decide on risk management measures.




For 1829/2003: On a case-by-case basis the individual experts from the research institutes with the expert competences needed could be involved in risk assessment of GMO application. For 2001/18: Seven members of the Scientific Committee for the Deliberate Release of GMOs into the Environment and Placing Products on the Market (SCDR) and their seven deputies were appointed by the Government on the proposal from the Ministry responsible for science, taking into account their expert system of assessment in science. The independent members of the committee have expertise in various fields including genetics, biology, agriculture, veterinary sciences, biochemistry and molecular biology, microbiology, and medicine. In addition, the SCDR may invite to the discussion other experts from the field relevant for the preparation of an expert opinion.

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: see below For 2001/18: No, only names and institutions are publicly available on the website of the MESP and Slovenian BCH. But there are other databases provided by the Ministry of Higher Education, Science and Technology that provide for bibliography search (e.g. Slovenian Current Research Information System (SICRIS), and with certainty CVs are also available.

139


For 1829/2003: On a case-by-case basis the individual experts from the research institutes with the specific expertise could be consulted. In addition, SCDR could be confer with an extra invited experts from the field relevant to the preparation of an expert opinion. For 2001/18: Mainly by SCDR but it may invite to the discussion other experts from the fields relevant to the preparation of an expert opinion.


For 1829/2003: / For 2001/18: Yes. But, if a member(s) of the SCDR cannot agree with the Committee's averall opinion or part of an oppinion they could attach a sound objection to the opinion.


For 1829/2003: / For 2001/18: Written procedure

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: / For 2001/18: Experts were appointed by the Government for four years. After that period, Ministry responsible for science, prepare new proposal of experts taking into account their expert system of assessment in science.


For 1829/2003: / For 2001/18: They are not employed as government officials and they are academics.

140


For 1829/2003: / For 2001/18: Beside the Management of GMOs Act (OJ RS 23/2005) the main groundwork elements for SCDR are Decree on the Manner of Operation of Scientific Committees (OJ RS 66/2003) and Rules of Procedures for the Scientific Committee for Deliberate Release that provides the procedures for ensuring the exclusion of interests and protection of confidential data related to the committee work. If yes, are the declarations of interest renewed annually or per topic? per topic/dossier If yes, are they published and if yes, where? No



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: No. 2001/18 - No, but there are approx. 8 projects that were finalized and the outcome was dealing with the risk assessment of microorganisms or plats or animals.


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD, FAO/WHO, EMEA, CODEX If not, can you specify in which area and explain why: / Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. /

141


GM-trees - In 2006, project dealing with the environmental risk assessmenta(ERA) and risk management in potential releases of GM-trees in Slovenia was issued. In the project, risk assesment metodology based of two parts, including an ERA platform table and a multi attribute decision support model. It combines individual expert opinions included in the ERA platform table where the outputs from the such a platform table serve as an inputs for the multi-attribute hierarchical model.


- methods for testing non-target organisms and baseline environmental conditions


/

Thank you for providing this very useful information.

142



SPAIN




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” - For food safety (food intended for human consumption) in every item (plants, microorganism, and animals), AESAN (Spanish Agency of Food Safety and Nutrition). - For feed, Ministry of Agriculture, Fisheries and Food - For environmental issues, MMA (Ministry of the Environment) see "Directive 2001/18/EC" Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. - Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): For food safety (food intended for human consumption), according to the Regulation it is EFSA's competence to perform the GMO risk assessment. AESAN evaluates the risk assessment reports from EFSA and the answers to the MS included in EFSAnet. When needed for specific points, AESAN consults its Scientific Committee and the CNA (National Center of Food). The Ministry of the Environment through the National Commission on Biosafety (CNB) studies the GMO environmental risk assessment reports from EFSA. Expertises on all areas described above are members of CNB. Number of applications assessed for which a national risk assessment report has been issued: Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?

143

Scientific Committee reports about food safety are published in Spanish in the page: http://www.aesan.msc.es/aesa/web/AESA.jsp National Commission on Biosafety minutes which includes the comments about EFSA environmental risk assessment reports are published on htpp://www.mma.es/portal/secciones/calidad_contaminacion/omg/


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: National Commission on Biosafety (CNB) from the Ministry of the Environment which is the competent authority for this Directive. The CNB is a technical consultive collegiate body assigned to the department of the environment. The chairman is from the Ministry of the Environment and it is also composed by technical representatives of different departments as environment, agriculture, health, industry and trade, science and interior, as well as for representatives of scientific institutions, appointed by the general secretary of the environment, and selected on the basis of their scientific expertise Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Yes Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): The CNB have experts for all these areas Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: Spain leaded the ERA of 12 part C applications. Finally, 3 national environmental risk assessment (ERA) reports were issued by the CNB Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: Since 1993, 394 part B notifications have been assessed by the CNB Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Yes, our national risk assessment reports are available in Spanish (htpp://www.mma.es/portal/secciones/calidad_contaminacion/omg/


In the case of applications under Regulation (CE) nº1829/2003, where several competent authorities are involved, the environmental risk assessment is discussed by the National


144

Commission of Biosafety and the final decision is taken by the Interministerial Committee of GMOs.


For 1829/2003 applications: For food safety: Different departments from AESAN (S.G. Risk Food Management and S.G. Scientific Coordination) work together to ensure the link between risk assessment and management. For 2001/18 applications: Every biosafety requirement or other condition applied to the authorised notifications are supervised by inspectors and officers of the Ministry of Enviroment and by experts of the CNB




For 1829/2003: For food safety, the Scientific Committee consists of 20 members, experts in the following areas: toxicology, microbiology, virology, nutrition, allergenicity, food technology, biotechnology, genetics, and food analysis For 2001/18: The Ministry have experts on ERA (4-5 experts) and in the CNB there are several independent scientific members with expertise in various fields, such as ecology, microbiology, virology, molecular biology, agronomy, zoology and human health. In addition, CNB´s work is supported by a secretariat made up of a multi-disciplinary staff

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: For food safety, the CVs of the members of the Scientific Committee are published in the web page http://www.aesan.msc.es/aesa/web/AESA.jsp For 2001/18: No. Their names are included in a list publicated in our webpage: htpp://www.mma.es/portal/secciones/calidad_contaminacion/omg/cnb/index.htm

145


For 1829/2003: For food safety, yes For 2001/18: Yes, the CNB is the consultative body of Spanish competent authority (central government and autonomous regions), entrusted to evaluate and inform previously on the potential risk to human health and the environment of all the request to realize activities with GMO. The scope of CNB covers all field, ranging from agriculture to medicine and from contained use to deliberate release of GMOs. All applications submitted are evaluated by the CNB which supply with an environmental risk assessment report to the corresponding competent authority.


For 1829/2003: For food safety, yes For 2001/18: Yes


For 1829/2003: For food safety, the advice is provided through discussion in meetings For 2001/18: Through discussion in meeting. The CNB meets more or less once a month.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: For food safety, the Scientific Committee members are appointed for four years For 2001/18: The CNB was officially appointed in 1999 according to the first Spanish law implementint Directive 90/220/EEC (although it was working since 1992 in an interinm way). Since then, some experts are the same and others have been replaced by new ones appointed during the last years.


For 1829/2003: AESAN and CNA representatives are government officials; members of the Scientific

146

Committee are academics. For 2001/18: Mainly they are scientists and academics


For 1829/2003: For food safety, yes For 2001/18: No If yes, are the declarations of interest renewed annually or per topic? If yes, are they published and if yes, where?



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: The environmental risk assessment guidance is included in the domestic legislation


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): We take into account guidelines and consensus documents from EFSA, OECD, Codex. If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. It is the same


147



It would be greatly desirable more harmonisation on risk assessment methodologies between Directive 2001/18 and Regulation 1829/2003 procedures. It should be discussed whether or not a different GMO risk assessment approach could be followed for food, feed or environmental issues. In fact, the actual decision procedure is not based only in purely scientific criteria protecting human, animal and environmental safety, but also in other “legitimate factors” that should be taken into account (White Book of the European Commission on Food Safety). It seems to be clear that “legitimate factors” for the food (consumer opinion), environmental (environmental considerations and other parties opinion) or feed (raw material prices) are extremely different and, in some cases, non-compatible Furthermore, the CNB would suggest that a more detailed and stepwised procedure for the environmental risk assessment for genetically modified plant hybrids could be carried out by the EFSA GMO panel, especially on issues like a molecular characterisation and toxicological studies. It is CNB opinion that the current guidelines document for hybrids is not enough detailed and insufficient for carring out the overal environmental risk assessment of these GMO products.

Thank you for providing this very useful information.

148



SWEDEN




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” - For GM food: National Food Administration (NFA), the Swedish Gene Technology Advisory Board (SGTAB) by consultation. - For GM feed, GM non food plants, GM non food animals and GM non food microorganisms: Swedish Board of Agriculture (SBA), the Swedish Gene Technology Advisory Board (SGTAB) by consultation. The Swedish Gene Technology Advisory Board is a consultative body that was established in 1994. The Board consists of seven members from the different political parties in the parliament, and seven experts. The areas of competence of the experts are Ethics, Plant Breeding, Cell- and Molecular Biology, Biochemistry, Ecology, Animal Breeding and Genetics and Virology. The chairperson and vice chairperson are both legal experts. The members of the Board are appointed for four years. The NFA and SBA consults the SGTAB on dossiers under Regulation (EC) No 1829/2003. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. - NFA and SBA are represented in the GMO EFSAnet, but not SGTAB. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): - NFA has expertise in molecular characterisations, nutrition, toxicology and allergenicity. - SBA has expertise in animal nutrition, molecular characterisation and environmental risk assessment.

149

Number of applications assessed for which a national risk assessment report has been issued: - Not applicable for GM food and feed, subsequent to implementation of Regulation 1829/2003/EC. Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? - No national risk assessment reports are produced. Information about and weblinks to EFSA opinions are published on the NFA and SBA websites


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: The Swedish Board of Agriculture - GM plants, GM feed and GM products not covered by the other authorities; Swedish Forest Agency - GM forest trees for wood production; Swedish Chemicals Agency - GM microrgansims nematodes, arachnids and insects; The Swedish Board of Fisheries - waterliving GMOs; Medical Products Agency - Medical GMOs. Co-operation with National Food Administration, The Gene Technology Advisory Board and Swedish Environmental Protecion Agency Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. - SBA and NFA are represented in the GMO EFSAnet. Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): - SBA has expertise in molecular characterisation environmental risk assessments and animal nutrition. NFA has expertise in molecular characterisation, nutrition, allergenicity and toxicology. See above. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 12, of which once as lead CA. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 119 Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? Part B: Yes, A summary, Swedish, www.sjv.se>växt, miljö vatten>genetiskt modifierade organismer>fältförsök. Part C: Yes, A summary, Swedish, not on the web.


By consultations.


150


For 1829/2003 applications: When a national risk assessor during the safety assessment of a GM Food/Feed, assessed by the EFSA GMO Panel, identifies an issue that require additional studies he/she informs the risk manager that may inform EFSA about the issue. At NFA (GM Food) risk assessors and risk managers meet on a regular basis to discuss different issues in the interface between risk assessment and risk management. Information regarding GM Food/Feed applications as well as links to EFSA GMO opinions are published on the NFA (GM Food) and SBA (GM Feed) websites. NFA and SBA are responsible for consulting national expert authorities like the SGTAB and other relevant stakeholders both during the risk assessment procedure and the risk management procedure. The Competent Authority presents an opinion to the Ministry. For 2001/18 applications: Part C: Risk assessment - Authority. Risk management - Ministry of Agriculture. The Competent Authority presents an opinion to the Ministry. Part B: Risk assessment and Risk management - Authority




For 1829/2003: - Toxicology: 2 -3 - Molecular characterisations: 1 - Allergenicity: 3 - Feed: 2 Several additional experts from consulted bodies. If environmental issues are concerned: 5-7. Competence in Molecular biology, biochemistry, ecology, plant physiology, agronomy, hortonomy, law, botany and plant breeding. For 2001/18: If only environmental issues: 5-7. If feed issues: 2. Competence in Molecular biology, biochemistry, ecology, plant physiology, agronomy, hortonomy, law, botany and plant breeding. Several additional experts from consulted

151

bodies. Several additional experts from consulted bodies



For 1829/2003: - Sweden does not have a specific scientific panel for GM-food/feed. Different expert bodies are consulted on a regular basis, especially SGTAB For 2001/18: National experts in close co-operation.


For 1829/2003: For 2001/18:


For 1829/2003: By written procedure and discussion among national experts. For 2001/18: By written procedure and discussion among national experts.

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: The risk assessment experts are employed as government officials and generally appointed on a permanent tenure of office. For 2001/18: No time limit


For 1829/2003: - Risk assessment expert are generally employed as government officials and have a university degree of education (see 2.6). For 2001/18:

152

Officials in an authority sorting under the Governement. However in the Swedish system for public administration, the authorities have a great degree of independence and the Minister must not interveen in a specific dossier. Political guidance is mainly provided through regulations.


For 1829/2003: - No specific Declaration of Interest concerning GMO- or 1829/2003 dossiers are required for national risk assessment experts employd as government officials at competent authority level. General Declarations of Interest are required for all employees at NFA. For 2001/18: Non-written declarations of interest must be made if factors exist that threat independence. Afters such a declaration, the expert is detached from the assessment. If yes, are the declarations of interest renewed annually or per topic? If required. If yes, are they published and if yes, where? No



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: No such document has been issued. Information regarding and links to EFSA GMO guidance documents as well as EFSA GMO opinions are published on the NFA (www.slv.se) and SBA (www.sjv.se)) websites


Yes, risk assessment guidance documents from other organisatins are in general very valuable for Swedish risk assessors. If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, OECD, FAO/WHO Codex Alimentarius guidance documents. Concerning risk assessment of GM food and feed, Sweden has confidence in and rely on the EFSA procedure and the EFSA GMO Panel If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. Concerning 2001/18 dossiers and environmental risk assessments in 1829/2003,

153

independent risk assessments are made.


Development and validation of bioinformatics-type allergenicity predictor systems are ongoing activities at the NFA since several years back. Although these systems are applicable to a variety of scientific and regulatory areas within allergology, risk assessment of GMO has been a major incentive to the project.


A gradual development of profiling technologies, particularly proteomics and metabolomics, within the area of compositional comparison of genetically modified with conventional crops, hold considerable potential and might - after being validated - significantly contribute to an altogether improved risk assessment of GM-crops and GM foods. In Sweden, development of profiling technology for a variety of purposes occurs at several university departments.


154



SWITZERLAND




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” 1829/2003 not applicable, but corresponding procedure. For foods: according to Ordinance of the FDHA on genetically engineered foods, Federal Office of Public Health (lead), Federal Office of Agriculture, Federal Office of Environment (supported by Swiss Expert Committee for Biosafety), Federal Veterinary Office; for feeds: according to Ordinance on feeds, FOA (lead), FOPH, FOE, FVO. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): FOPH: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity; FOA: molecular characterisations, compositional analysis, nutrition, toxicology; FOE: environmental risk assessment,FOA: feed safety/risk assessment, FVO: animal health. Number of applications assessed for which a national risk assessment report has been issued: 4 Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? not under 1829/2003. Language: german, reports on GMOs for food use available upon request.

155


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: 2001/18/EC not applicable, but procedure corresponding to Part B: FOE (lead, supported by Swiss Expert Committee for Biosafety), FOPH, FOA, FVO; corresponding to Part C: FOPH (lead food), FOA (lead feed), FOE, FVO. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. No Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): FOPH: molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity), FOE: environmental risk assessment,FOA: feed safety/risk assessment, FVO: animal health Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: 4 (1 soybean, 3 maize, food, feed) Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: 4 (1 field trial 2004, 3 requests for field trials assessed 2007, not yet done) Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable? 3 requests assessed 2007: http://www.bafu.admin.ch/dokumentation/medieninformation/00962/index.html?lang=de&msg-id=14305


Report written by lead organisation, sent to other organisations for comment. FOPH consent required in any case; FOE consent required when LMOs concerned; FOA, FVO consent required


For 1829/2003 applications: 1829/2003 not applicable, but risk assessment done by experts, opinion issued by Federal Office


156

Director, decision by lead Federal Office Director. For 2001/18 applications: 2001/18/EC not applicable, but risk assessment done by experts, opinion issued by Federal Office Director, decision by lead Federal Office Director




For 1829/2003: 6 For 2001/18: 6



For 1829/2003: Assessment done in Federal Offices, but the Swiss Expert Committee for Biosafety is consulted. For 2001/18: Assessment done in Federal Offices, but the Swiss Expert Committee for Biosafety is consulted


For 1829/2003: Swiss Expert Committee for Biosafety: majority vote. For 2001/18:

157

Swiss Expert Committee for Biosafety: majority vote.


For 1829/2003: Federal Offices: written report, SECB: discussion and written report For 2001/18: Federal Offices: written report, SECB: discussion and written report

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: SECB: 4 years, re-election possible, max. 12 years For 2001/18: SECB: 4 years, re-election possible, max. 12 years


For 1829/2003: Federal Offices: government officials, SECB: academics etc. elected by Federal Council (government) For 2001/18: Federal Offices: government officials, SECB: academics etc. elected by Federal Council (government)


For 1829/2003: For the SECB, there are no written declarations of interest. The question regarding the expert’s independence is decided within the Committee per topic. For 2001/18: For the SECB, there are no written declarations of interest. The question regarding the expert’s independence is decided within the Committee per topic. If yes, are the declarations of interest renewed annually or per topic? Renewed per topic: If the SECB rules on concrete enforcement tasks i.e. on permit applications, a Committee member must stand down if he or she either has a personal interest in the issue; represents a party, or could become involved in the issue for other reasons.? If yes, are they published and if yes, where? not published

158



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: food and feed: Ordinance of the FDHA on Genetically Engineered Foods, annex LMOs, environment: Ordinance on the Deliberate Release into the Environment


Yes If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): EFSA, CODEX If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. 1829/2003 and 2001/18 are not applicable


FOE: … Agroscope environmental effects, co-existence, NRP 59.


Co-existence


159



UNITED KINGDOM




Name of the organisation(s) and specify “for GM plants and/or GM microorganisms and/or GM animals” For health aspects, the lead department in the UK is the Food Standards Agency (FSA). Where it is necessary to supplement the opinions issued by EFSA, the FSA can seek advice from two committees of independent experts, the Advisory Committee on Novel Foods and Processes (ACNFP) and the Advisory Committee on Animal Feedingstuffs (ACAF). For environmental aspects the responible bodies are the Department for Environment Food and Rural Affairs (Defra) and the devolved administrations in Scotland, Wales and Northern Ireland, in consultation with the Advisory Committee on Releases to the Environment (ACRE) on all GM applications. Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Defra and FSA officials are on EFSAnet Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): FSA / ACNFP –food safety FSA / ACAF – feed safety Defra/ACRE - environmental risk assessment Number of applications assessed for which a national risk assessment report has been issued: None Are your national risk assessment reports under Regulation (EC) No 1829/2003 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?

160


Name of the organisation(s) and specify “for GM plants and/or GM micro-organisms and/or GM animals”: Department for Environment Food and Rual Affairs (Defra) and the devolved administrations in Scotland, Wales and Northern Ireland in consultation with the Advisory Committee on Releases to the Environment (ACRE), the Food Standards Agency, the Joint Nature Conservation Committee and, when applicable, the Advisory Committee on Animal Feedingstuffs, on all GM applications Is(are) these organisation(s) represented in the GMO EFSAnet for commenting or access to dossiers? If not, please specify which. Defra officials are on EFSAnet Specify areas of expertise of (each of) the above organisation(s) (molecular characterisations, compositional analysis, nutrition, toxicology, allergenicity, environmental risk assessment): Defra/ACRE expertise on molecular characterisation and environmental risk assessment. FSA/ACAF have expertise on compositional analysis, nutrition, toxicology and allergenicity. Number of applications assessed under Part C of the Directive, for which a national risk assessment report has been issued: The UK has been the lead Member State for 2 applications under Directive 2001/18. ACRE also provides advice on applications where other Member States lead and its advice is also available on the Defra website. Number of applications assessed under Part B of the Directive, for which a national risk assessment report has been issued: ACRE has assessed 11 applications under Part B of directive 2001/18 (5 non-crop). Are your national risk assessment reports under Directive 2001/18 publicly available? If yes, in which language and could you provide the reference or weblink if applicable?



For 1829/2003 applications: The Divisions that have policy responsibility within the Food Standards Agency for food and feed safety also provide the administrative and scientific Secretariats for ACNFP and ACAF. These Divisions ensure that risk management decisions are linked appropriately to risk assessment advice on food and feed safety (whether from EFSA and/or national committees). For 2001/18 applications: The Division that has the policy responsibility within Defra for environmental safety also provides the administrative and scientific Secretariat for ACRE and consults its other risk assessors: the Health and Safety Executive, the Food Standards Agency, statutory nature conservation agencies and GMO regulators in Northern Ireland, England, Wales and Scotland.. The risk assessors also consider mitigation and monitoring as this contributes to


161

the overall risk assessment (in accordance with Council Decision (2002/623/EC). Defra staff manage the risk assessment and management process and draft written conclusions and recommendations based on the scientific evidence (i.e. in the same way as the GMO Panel). The decision on whether a GMO should be approved is made by UK Ministers and Ministers in the devolved administrations.

2 Your national risk assessment Experts Please specify for each question if the situation under Regulation 1829/2003 and under the Directive 2001/18 is different or not. If different, please specify the procedures under both legislations.


For 1829/2003: ACNFP: Members have a wide range of expertise including molecular biology, microbiology, toxicology, food processing, ethics, and consumer affairs. Where necessary, additional expertise can be called upon from other UK advisory committees (e.g. on toxicity of chemicals), The committee currently has 14 members. ACAF: Members have expertise in animal nutrition, microbiology, toxicology, human medicine, veterinary medicine, novel technology (including genetic modification), feed manufacture and feed materials. The Committee also has farmer, enforcement, consumer and lay members. ACAF currently has 14 members, 5 of whom are also members of the Committee's GM Sub-group. ACRE: Members are appointed for their expertise in relevant disciplines such as molecular biology, microbiology, entomology, ecology, farming practice, agronomy, virology, biodiversity, conservation and sustainable agriculture. The committee currently has 13 members. For 2001/18: as for 1829/2003

2.2 Are the CV’s of your experts publicly available? If yes, where? For 1829/2003: Brief details of committee members are on the web at http://www.acnfp.gov.uk/acnfpmembership/ http://acaf.food.gov.uk/more_about/ http://www.defra.gov.uk/environment/acre/about/members.htm For 2001/18: as for 1829/2003e


For 1829/2003: Where national assessments are carried out, these are by panels of experts (ACNFP / ACAF / ACRE). See 2.1 For 2001/18:

162

as for 1829/2003


For 1829/2003: The UK advisory committees generally operate by consensus. In extreme cases it would be possible for members who disagree with the majority view to issue a minority report, although this has not happened in relation to either 1829/2003 or 2001/18 For 2001/18: as for 1829/2003


For 1829/2003: Issues are discussed in committee meetings and the decisions taken are recorded in minutes published on the web. Where the timescale for obtaining advice does not coincide with the meeting schedule, discussions are carried out by e-mail and the outcome recorded at the next meeting and in the minutes. On any issues of substance more detailed written advice is drafted and published on the web. The committees also issue annual reports which summarise their activities, including formal opinions. For 2001/18: as for 1829/2003

2.6 For how long is a national expert (or Panel) appointed? For 1829/2003: ACNFP and ACAF members are appointed for an initial term of 3 years, which can be extended for a second 3 year term. In exceptional cases, an appointment may be extended to a third term. ACRE members are appointed for terms of 3 or 4 years, and if reappointed can serve 10 years in total For 2001/18: as for 1829/2003


For 1829/2003: Committee members are not government officials, but independent experts who receive a modest fee for the time they spend on committee business. Most ACNFP members are either scientists working for universities and research institutes, or consultants. ACRE members are mainly scientists working for universities or research institutes or they have practical expertise in farming. The ACRE secretariat is made up of officials from Defra. Representatives of other Government departments and agencies attend and can contribute to ACRE meetings For 2001/18: as for 1829/2003

163


For 1829/2003: Committee members' interests are declared in a register maintained by each committee Secretariat. For 2001/18: as for 1829/2003 If yes, are the declarations of interest renewed annually or per topic? The registers are updated annually but other amendments are made during the year e.g. if a new member is appointed or a member changes jobs. Any specific interests in items under discussion are recorded in the minutes of the Committee meetings. If yes, are they published and if yes, where? The registers are on the web at http://www.acnfp.gov.uk/acnfpmembership/ http://acaf.food.gov.uk/more_about/ http://www.defra.gov.uk/environment/acre/about/interests.htm



Name of the document(s) + specify publication year, institution/authors, publication site, applied for 1829/2003 applications and/or 2001/18 applications: The following guidance has been drawn up by ACRE and is used when assessing environmental risk: -Guidance on assessing the environmental impact of genetically modified crops on the soil environment (2006): http://www.defra.gov.uk/environment/acre/soilecology/acre_soilecology_guidance.pdf -Guidance on Best Practice in the Design of Post-market monitoring Plans in Submissions to the Advisory Committee on Releases to the Environment (2004): http://www.defra.gov.uk/environment/acre/postmarket/acre_postmarketmonitor-guidance.pdf -Guidance on best practice for the presentation and use of molecular data in submissions to the Advisory Committee on Releases to the Environment (2002): http://www.defra.gov.uk/environment/acre/molecdata/pdf/acre_mdr_guidance.pdf -The criteria used by ACRE to gauge harm when giving advice on the risks of releasing genetically modified organisms to the environment (2002): http://www.defra.gov.uk/environment/acre/harm/pdf/acre_harm_report.pdf ACRE guidance on principles of best practice in the design of genetically modified plants (2001): http://www.defra.gov.uk/environment/acre/bestprac/guidance/index.htm


Risk assessment by ACNFP and ACAF is carried out according to the current EFSA guidance documents on plants and microorganisms.

164

The UK's competent authority under Directive 2001/18/EC does not rely on risk assessment guidance from other organisations. However, we do pay close attention to the EFSA guidance on the risk assessment of GM plants in order to map our views with EFSA's current thinking. We consider relevant OECD documents but do not rely on them If yes, please specify which other organisation (e.g. OECD, FAO/WHO, codex, EFSA, other….): If not, can you specify in which area and explain why: Is there a difference under 1829/2001 or 2001/18 or is it the same? If different, please specify. no difference


The Food Standards Agency has a research programme that supports the safety assessment of GM and novel foods, in order that the most up to date scientific knowledge may be used. Details of this research programme can be found at: http://www.food.gov.uk/science/research/researchinfo/foodcomponentsresearch/novelfoodsresearch/g03researchprog/ Defra funds research projects that underpin environmental risk assessment. In the near future we will be publishing reports on: -quantitative approaches to the risk assessment of GMOs -the environmental impact of crop production practice beyond the farm-scale evaluations (i.e. lessons learned about the amount and type of data that is useful in considering impacts on farmland biodiversity without carrying out experiments on the scale of the FSE).


If they can be successfully validated, the various –omics techniques may have a place in risk assessment in future. We also envisage a need for guidance on the risk assessment of GM animals, building on the work undertaken by the Codex Alimentarius. Defra does not envisage developing risk assessment methodologies in the near future. However, we are interested in methodologies for assessing the risks posed by Bt crops on non-target organisms. (It is very unlikely that Bt traits will be developed in the near future that are targeted against insect pests in the UK. At present, we do not have a problem with the pests targeted by the current Bt crops. However, it is conceivable that a GM herbicide tolerant crop could be grown in the UK that had a Bt trait). We are interested in EFSA's work on the assessment of GM crops modified to produce non-food/feed products such as pharmaceuticals


No

165