member states reporting under reach art. 117 / clp artmember states reporting under reach art. 117 /...

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Case Id: d9e18530-bd79-4f4a-bd82-60814eae8d52Date: 28/05/2015 17:27:43

Member States Reporting under REACH art. 117 / CLPart.46

Fields marked with * are mandatory.

General Information

Please note that depending on what your answers are throughout the questionnaire, hiddenquestions may show up, so please disregard the numbering in case it does not follow a logicorder.

A glossary is available in the section 'background document'.

*1.Which Member State are you reporting for?

Spain

*2. Primary contact person's name

Esther Martín / Ana Fresno ([email protected])

*3. Please provide an email address for the primary contact person

[email protected]

Theme 1 - Information on the Competent Authority

*

*

*

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4. Please explain how Competent Authorities are organised for the operation of REACH in yourcountry? (Please note that this Section does not include information on enforcement authoritiesthat will be covered under Theme 9 on enforcement)

At national level, "Real Decreto 1802/2008” appoints two national

competent authorities responsible for the implementation of REACH: the

Ministry of Health, Social Policy and Equality for the aspects related

with human health issues and the Ministry of Agriculture, Food and

Environment for the aspects related to environmental issues. Althouth

enforcement competences rely on regional authorities (Comunidades

Autónomas), both national authorities have a coordination role between

the Spanish enforcement authorities.

*5. How many Competent Authorities are responsible for REACH?

A description of each Competent Authority will be asked in the following sections. Similar series of questions

corresponding to the number of Competent Authorities you enter will appear below.

2

One / First Competent Authority Responsible for REACH

*6. What is the name of the Competent Authority?

Ministerio de Sanidad, Servicios Sociales e Igualdad (Ministry of

Health, Social Services and Equality). Dirección General de Salud

Pública, Calidad e Innovación (General Directorate of Public Health,

Quality and Innovation.)

*7. What is the address of the Competent Authority?

Paseo del Prado, 18-20

28071 Madrid (Spain)

*8. What is the email address of the Competent Authority?

[email protected]

*9. What is the telephone number of the Competent Authority?

+34 915962084 /+34 915962085

*

*

*

*

*

3

*10. What part of REACH does this part of the Competent Authority deal with?Please choose one or more answers.

AllEvaluationRisk AssessmentHelpdeskAuthorisationRestrictionRegistrationOther

*If Other, please list the other parts of REACH that this part of the Competent Authority deals with:

Enforcement coordination ( E.g. Point of contact between ECHA / other

Member states with Spanish Enforcement Authorities).

We participate in the following REACH groups/bodies: ECHA Member State

Committee, ECHA Forum, Risk Communication Network, CMR Coordination

Group, REEG (REACH Exposure Expert Group), RIME (Risk Management Expert

Meetings).

*11. From what part of Government does this part of the Competent Authority have authorityfrom?Please choose one or more answers.

EnvironmentOccupational Health and SafetyPublic HealthConsumer ProtectionEconomy/IndustryOther

*12. Please specify the number of staff of the Competent Authority working on the implementationof REACH:

8

*

*

*

*

4

*13. Do you have specialised staff in the following categories? Please quantify these skills in FTE

(Full Time Equivalent).

For a definition of Full Time Equivalent, please refer to the glossary.

Number of FTE

Toxicologist 3

Ecotoxicologist 0Chemist 1

Exposure Assessor 1Risk Assessor 1

Risk manager 1

Economist 0

IT 0.1

Communication 0

Other 0

*14. Is the level of expertise of the Competent Authority adequate to deal with all requirementsunder REACH?

Yes, although there are difficulties to participate more actively in all

REACH processes due to the limited number of specialised staff. In

addition, we do not have expertise in socio-economic analysis.

*15. Are the staff of the REACH Competent Authority involved in other chemical legislation?

YesNo

*

*

*

5

*16. What other chemical legislation are the staff of the REACH Competent Authority involved in?

Please choose one or more answers.

PIC RegulationFood legislationWorkers Protection legislationCosmeticsMedical devicesBiocidesCLPPesticidesPOPsOther

*17. Are there any other institutions (agency, institute, regional authorities) that the Competent

Authority works with in relation to REACH issues?

YesNo

*If Yes, please list the other institutions that the Competent Authority works with:

Regional authorities that are REACH enforcement authorities.

Coordination with other Ministries (Environment, Labour, Industry,

Defence).

*18. Does the Competent Authority outsource any of its work?

YesNo

*19. Does the Competent Authority have appropriate financial resources?

1 = Very low (not appropriate at all); 2 = Low (of some relevance but not of any great significance); 3 = Medium

(reasonably appropriate); 4 = High (highly appropriate); 5 = Very high (completely appropriate)

12345

*

*

*

*

*

6

*20. Does the Competent Authority have appropriate technical resources (understood in terms of

expertise, skills and competences of the staff)?

12345

*21. Does the Competent Authority have appropriate human resources (understood in terms of

number of staff)?

12345

22. Space is available below to provide further comments on the resourcing of the CompetentAuthority.

Human resources are considered insufficient to perform all requirements

REACH imposes to MSCA.

Second Competent Authority responsible for REACH

*6b. What is the name of the Competent Authority?

Ministry of Agriculture, Food and Environment – General Deputy for air

quality and the envirionment

*7b. What is the address of the Competent Authority?

Plaza San Juan de la Cruz s/n, 28071 – Madrid (Spain)

*8b. What is the email address of the Competent Authority?

[email protected]

*

*

*

*

*

7

*9b. What is the telephone number of the Competent Authority?

+34 91 597 59 08

*10b. What part of REACH does this part of the Competent Authority deal with?Please choose one or more answers.

AllEvaluationRisk AssessmentHelpdeskAuthorisationRestrictionRegistrationOther

*If Other, please list the other parts of REACH that this part of the Competent Authority deals with:

We participate in the following REACH groups/bodies: ECHA Management

Board, Helpnet Steering Group, ECHA Forum (invited expert), PBT Expert

Group, Risk Communication Network,

*11b. From what part of Government does this part of the Competent Authority have authorityfrom?Please choose one or more answers.

EnvironmentOccupational Health and SafetyPublic HealthConsumer ProtectionEconomy/IndustryOther

*12b. Please specify the number of staff of the Competent Authority working on theimplementation of REACH?

4

*

*

*

*

*

8

*13b. Do you have specialised staff in the following categories? Please quantify these skills in FTE

(Full Time Equivalent).

For a definition of Full Time Equivalent, please refer to the glossary.

Number of FTE

Toxicologist 0

Ecotoxicologist 2Chemist 0.5

Exposure Assessor 0.5Risk Assessor 0.5

Risk manager 0.5

Economist 0

IT 0

Communication 0

Other 0

*14b. Is the level of expertise of the Competent Authority adequate to deal with all requirementsunder REACH?

Yes

*15b. Are the staff of the REACH Competent Authority involved in other chemical legislation?

YesNo

*

*

*

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*16b. What other chemical legislation are the staff of the REACH CA involved in?


PIC RegulationFood legislationWorkers Protection legislationCosmeticsMedical devicesBiocidesCLPPesticidesPOPsOther

*17b. Are there any other institutions (agency, institute, regional authorities) that the Competent

Authority works with in relation to REACH issues?

YesNo

*If Yes, please list the other institutions that the Competent Authority works with:

INIA - National Institute for Agricultural Research and Experimentation

*18b. Does the Competent Authority outsource any of its work?

YesNo

*If yes, please provide details on who the Competent Authority outsources parts of its work to:

TRAGSATEC – Tecnologías y Servicios Agrarios S.A

*

*

*

*

*

10

*And on what type of expertise is outsourced:

Helpdesk

*19b. Does the Competent Authority have appropriate financial resources?



12345

*20b. Does the Competent Authority have appropriate technical resources (understood in terms of

expertise, skills and competences of the staff)?

12345

*21b. Does the Competent Authority have appropriate human resources (understood in terms of

number of staff)?

12345

*

*

*

*

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22b. Space is available below to provide further comments on the resourcing of the CompetentAuthority.

During the period between 2010 and 2014, there has been a reduction of

financial resources, which has resulted in a reduction of staff and

external contracts.

Theme 2: Information on cooperation and communication with otherMember States, the European Chemicals Agency (ECHA) and theCommission

*23. How could the communication and collaboration for REACH between Member States be

improved?

1,800 character(s) maximum

There are no specific concerns regarding the communication between

MSCAs. Measures made by ECHA, Forum and Commision for improving

interlinks between MSCAs during this period have been very useful.

In addition It would be necessary better coordination by Commission in

order to harmonize at Community level issues of implementation of the

Regulations.

*24. How could the collaboration with other agencies in your country be improved?


Better collaboration with other national institutions such as Custom

authorities would be very useful for the MSCAs. In that sense, it would

be much easier if harmonization of procedures at European level is

increased. This could be achieved with the promotion of REACH

discussions in the agenda of the correspondent non REACH European

bodies.

*

*

12

*25. How could the communication and collaboration with ECHA be improved?


There are no specific concerns regarding communication and collaboration

between REACH MSCA and ECHA. It can be considered effective during this

period. Activities like different workshops or promoting networks like

RIME have facilitated the work of the MSCA. Also, the work of ECHA

secretariats in the diferent ECHA bodies (comitees and Forum) has also

been productive.

It would be helpful to know who is who in ECHA in order to know to whom

you have to contact with.

*26. How could the exchange of information and dialogue between Member States and the

Commission be improved?


We would appreciate to be better informed about Commission activities in

problems linked to other policies arise.

Regarding CIRCABC as the IT tool for comunication between MSCA and

Commision, improvement of the usability could be considered such as bulk

download of documents.

Theme 3: Operation of the national helpdesk

*27. Please provide the name of the organisation(s) responsible for operating the Helpdesk(s) for

REACH.

Ministry of Agriculture, Food and Environment.

*28. What is (are) the address(es) of the Helpdesk(s)?

C/Julián Camarillo, 6B, 28037 – Madrid (Spain)

*

*

*

*

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*29. What is (are) the web page address(es) of the Helpdesk(s)?

www.portalreach.info

*30. What is (are) the email address(es) of the Helpdesk(s)?

[email protected]

*31. What is (are) the telephone number(s) of the Helpdesk(s)?

+34 91 434 57 30

*32. What is the institutional structure of the Helpdesk(s)?

Separate independent entity(ies)Part of Competent AuthorityPart of business association/chamber of commerceOther

*

*

*

*

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*33. Please quantify these skills in FTE (Full Time Equivalent).

Number of FTE

Toxicologist 0.4

Ecotoxicologist 0.4

Chemist 0.3

Exposure Assessor 0.3

Risk Assessor 0.2

Risk manager 0

Economist 0

IT 0.2

Communication 0.2

Other 0

*34. Is the level of expertise adequate to respond to all enquiries?

YesNo

*35. For which topics does the national helpdesk feel it necessary to refer the enquirer to the ECHA

helpdesk?

IT-tools: REACH-IT and IUCLID issues.

*36. What are the services offered by the Helpdesk?


WebsiteNewsletterAdvice servicesTrainingsMediation / conflict resolutionOther

*

*

*

*

15

*37. In which language(s) are these services accessible?

Spanish and English

*38. Is the same Helpdesk used to provide help to Industry on CLP?

YesNo

*39. Does the Helpdesk receive any non-governmental support?

YesNo

*40. Please describe the Helpdesk quality assurance mechanisms:

There are internal procedures.

*41. Is ISO9000 norm in place?

YesNo

*

*

*

*

*

16

42. How many enquiries does the Helpdesk receive per year?

1 - 100 101 - 1000 > 1000

*2010

*2011

*2012

*2013

*2014

*43. How are the majority of enquiries received?


EmailPhoneFaxLetterOtherNo information

*44. Do you provide specific advice to SME's?

YesNo

If yes, please specify how this advice is customized for the needs of SMEs.

The helpdesk tries to give more concrete answers with a simpler

language, taking into account the experience acquired and on a case by

case bases.

*

*

*

*

*

*

*

17

%3.85

%1.53

%2.45

%0.33

%32.03

%7.29

*45. What is the company size of enquirers? (please specify the percentage of the total each of

them represent)

If no information is available for a specific type of company, please indicate N/A in the corresponding box.

%

Large enterprises N/A

Medium enterprises N/A

Small enterprises N/A

Micro enterprises N/A

Other N/A

*46. For each type of enquiry received, please provide the percentage of the total number of

enquiries during the reporting period:Pre-registration

Please insert a figure. The individual percentages should add up 100% altogether.

*Registration

*Evaluation

*Authorisation

*Restriction

*Testing (Information requirement/registration)

*

*

*

*

*

*

*

18

%2.19

%0.73

%1.72

%0.07

%9.42

%3.05

%0.80

%1.59

%2.25

*Data sharing

*Enforcement

*CSR preparation

*CLP Classification

*CLP Labelling

*CLP Packaging

*CLP Classification and labelling inventory

*SIEFs

*REACH-IT

*

*

*

*

*

*

*

*

*

19

%8.75

%0.60

%8

%4.38

%3.45

%4.24

%1.39

*IUCLID5

*Downstream user obligations

*Only representative obligations

*Obligations regarding articles

*Safety Data Sheets

*SVHC

*Other

*47. Are enquiries received mostly:

'Straight-forward' is understood as those enquiries that can be answered without performing any prior research.

'Complex' is understood as those enquiries that require a minimum level of research before been answered or that

demand exhaustive elaboration.

ComplexStraightforwardNo information

*

*

*

*

*

*

*

*

20

%60

%40

*48. What proportion of enquiries received are deemed to be: 1) straight forward

Please provide an approximate estimation as an average per year. The individual percentages should add up 100%

altogether.

*2) complex

49. How long, on average, does it take to respond to the following types of questions?

4hours

1day

3days

1week

2weeks

> 2weeks

Noinfo

*Straight forwardquestions

*Complex questions

*50. Are any types of enquiry outsourced?

YesNo

*52. Does the Helpdesk seek feedback on its performance?

YesNo

*53. Does the Helpdesk review its performance and consider ways to improve its effectiveness?

YesNo

*

*

*

*

*

*

*

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*If yes, what were the measures taken to improve its effectiveness?

There is not a formal procedure. Improvement is based on daily work and

in the experience gained.

54. How could the cooperation between Helpdesks Helpnet be improved?under


The mechanisms in place are adequate but there is a lack of staff and

therefore time.

55. How could the cooperation between Helpdesk Helpnet be improved?outside


Cooperation has to be made inside HelpNet for harmonization.

*56. How frequently do you use HelpEx?

DailyWeeklyMonthlyLess frequently

Theme 4: Awareness raising activities

*57. Has the Member State carried out any specific awareness raising activities?

YesNo

*

*

*

22

*58. What types of activities have been carried out?


Television spotsArticles in NewspapersRadio spotsSpeaking eventsInformation seminarTelephone surveysLeaflets and newslettersArticles in industry magazinesWebsite / Social MediaOther

*59. Who is the target audience for your awareness raising activities?


Consumers directlyConsumers indirectly through multipliers (media, associations etc)SME in downstream sectorsAll companies in downstream sectorsSMEs in chemicals sectorAll companies in chemicals sectorOther

60. Please describe how the information was adapted for the specific target audience:

We have tried to adapt the language and the content of the messages to

the sector, knowledge of the audience and the potential needs of

specific sectors. Also, information is adapted based in experience

gained over the years.

*

*

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61. How effective was each type of activity?



If you have not ticked an activity in question 59, please state N/A.

1 2 3 4 5 N/A

*Television spots

*Articles in Newspaper

*Radio spots

*Speaking events

*Information seminar

*Telephone surveys

*Leaflets and newsletters

*Articles in industry magazines

*Websites / social media

*Other

*62. Do you measure the effectiveness of the activities?

YesNo

*64. Do you have a REACH webpage/website?

YesNo

*

*

*

*

*

*

*

*

*

*

*

*

24

65. Do you have a single webpage for REACH or multiple pages?

Single webpageMultiple webpages

66. How frequently is the REACH webpage visited (per month)?

1-100101-500501-50005001+No information

Theme 5: Information on the promotion of the development,evaluation and use of alternative test methods

*67. Does the Member State contribute to EU and/or OECD work on the development and

validation of alternative test methods by participating in relevant committees?

YesNo

*68. What has been the overall public funding on research and development of alternative testing in

your Member States each year?

Euros 0-10,000Euros 10,001-100,000Euros 100,001-1,000,000More than Euros 1, 000, 000No information

*

*

25

69. Please mention other relevant activities carried out on information on the Promotion of theDevelopment, Evaluation and Use of Alternative Test Methods:

There is small funding for research and development on alternative test

methods from public sources.

The National Contact Point on Alternatives has a cooperation agreement

with the Spanish Platform for Alternatives (REMA) on different

activities for the dissemination of information in all aspects related

to the concept of the 3Rs: Reduction, Refinement and Replacement of

animal use in experimentation. Alternatives are promoted by awarding

prizes and scholarships for attendance at scientific conferences and

meetings, and organizing and collaboration in scientific activities on

alternatives and animal protection. National experts are consulted in

priorization and validation activities.

Theme 6: Information on participation in REACH Commission andECHA expert groups / committees (Forum, REACH Committee,MSC, RAC, SEAC, CARACAL, RCN, Helpnet)

*70. How effective is the work of the FORUM Committee?



12345

71. Please specify if needed:


*

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72. How could the effectiveness be improved?


We support the use of working groups for the effectiveness and

efficiency of Forum activities. Nevertheless, the number of active

working groups should not be too high in order to be manegable for the

members. Increasing the use of internet meeting and providing IT tools

for managing the discussions would facilitate the work the working

groups. The big number of e-mails received could be better managed with

an easy to manage IT tool.

*73. How effective is the work of the REACH Committee?

12345





Documents could be provided earlier for preliminary discussion.

*76. How effective is the work of the Member States Committee (MSC)?

12345

*

*

27





Better use of webex tools. Plenary discussions could be limited to well

defined final issues.

*79. How effective is the work of the Risk Assessment Committee (RAC)?

12345



The work of RAC and SEAC is very demanding in terms of time and

dedication. There are difficulties in nominating experts for the

Committees since there is no enough staff in the CA that could assume

the required tasks without impairs their workload in the CA. In addition

no benefict is perceived from workers from other institutions for the

same reason.

In our country this situation is even worse since the money transferred

by ECHA from the fees goes directly to Spanish Treasure without

possibility to be refunded to the CA. Consequently, there is no

possibility to transfer to other institutions such as Universities that

could be interested.

*

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Certain measures have been taken during last 1.5 year, as the fast-track

procedure that has already probed effectivity. Other measures recently

implemented, as the A-list for the authorization dossiers still have to

probe effectivity. Finally, the future implementation of the co-opted

expert members for helping in the authorization dossiers seems to be a

good measure that will enhance the effectiveness of the Committee.

*82. How effective is the work of the Socio-Economic Committee (SEAC)?

12345



In our opinion the effectiveness of the SEAC is high but it should be

improved in order to cope with the increase in the expected workload,

mainly due to the new authorizations dossiers.

The work of RAC and SEAC is very demanding in terms of time and

dedication. There are difficulties in nominating experts for the

Committees since there is no enough staff in the CA that could assume

the required tasks without impairs their workload in the CA. In addition

no benefict is perceived from workers from other institutions for the

same reason.

In our country this situation is even worse since the money transferred

by ECHA from the fees goes directly to Spanish Treasure without

possibility to be refunded to the CA. Consequently, there is no

possibility to transfer to other institutions such as Universities that

could be interested.

*

29



Working groups have been created to suggest the committees (RAC and

SEAC) ways to improve the efficiency in the meetings. Some of the

working groups' recommendations have been implemented in the last

meetings (the conformity check and the key issues of the dossiers are

discussed in the same meeting) or are going to be implemented in future

meetings (the A-listing dossiers).

One way to improve the efficiency of the committees would be to help

applicants to prepare the dossiers, that could be done by the ECHA

secretariat.

*85. How effective is the work of the CARACAL (Competent Authorities for Reach and CLP)?

12345





Documents could be available earlier allowing MS to have a position

about them before the CARACAL meeting.

*

30

*88. How effective is the work of the Risk Communication Network (RCN)?

12345



RCN activities stopped in 2012.



*91. How effective is the work of the HelpNet Committee?

12345



*

*

31

170

1

82



HelpNet works but there is a lack of resources.

Theme 7: Information on Dossier Evaluation and SubstanceEvaluation activities

Dossier evaluation

*94. Has the Member State been involved in Dossier evaluation within the reporting period?

YesNo

*95. How many testing proposal draft decisions have you evaluated within the reporting period?Please insert a figure.

*96. How many proposals for amendment have you issued within the reporting period?Please insert a figure.

*97. On average how many persons-days are dedicated per year to dossier evaluation (excluding

presence in the Member State Committee)?

Please insert a figure.

*98. Do you outsource dossier evaluation to external contractors?

YesNo

*

*

*

*

*

32

6

*99. Do you consider that the dossier evaluation process, as currently structured, has to date

served its purpose?

YesNo

100. How could it be improved?


Limiting PfA to serious issues.

*101. Have you carried any follow-up actions in relation to dossier evaluation within the reporting

period?

YesNo

If yes, please describe enforcement actions and results obtained:

During this period, we have received from ECHA three statements of

non-compliance following a dossier evaluation decision. Two of them were

related with a testing proposal and one as a consequence of a

registration dossier compliteness check performed by ECHA. All cases

were investigated by the correspondent regional enforcement authorites

and the conclusions were communicated to ECHA. In all three cases

dossier updates were sent by the registrants although only one is closed

so far.

Substance evaluation

*102. Has the Member State been involved in substance evaluation within the reporting period?

YesNo

*103. How many substances evaluated resulted in a draft decision within the reporting period?Please insert a figure.

*

*

*

*

33

30

200

*104. On average, how many person-days have been employed in the evaluation of eachsubstance within the reporting period?Please insert a figure.

*105. On average, how many person-days have been employed in the decision-making of eachsubstance within the reporting period?Please insert a figure.

106. Indicate if possible what tasks have been most demanding in terms of resources:

Evaluation of the available information, elaboration of the draft

decision and responses to proposals for amendments. Technical problems

to access to IT-tools.

107. Please indicate the number of each type of staff that are involved in substance evaluation:

0 1-5 6-10 >10

*Toxicologist

*Ecotoxicologist

*Chemist

*Risk Assessor

*Social-Economic Analyst

*Exposure Assessor

*Other (please list):

*

*

*

*

*

*

*

*

*

34

*108. Do you outsource substance evaluations to external contractors?

YesNo

*109. Have you collaborated with other Member States in any of these evaluations within the

reporting period?

YesNo

*110. Have you initiated any action under other REACH processes as a consequence of substance

evaluation performed by you or another Member States (e.g. Annex VI dossier for harmonisedC&L, annex XV dossier for SVHC ID or restriction, other non-REACH regulatory action) withinthe reporting period?

YesNo

*If yes, please specify the action:

The preparation of a CLH dossier has been initiated after the evaluation

of a NONS substance.

111. What are the financial resources dedicated by your Member State to substance evaluation?

112. Do the fees delivered for evaluation equate the financial resources involved in substanceevaluation?

YesNo

113. Do you foresee an increase of resources dedicated to substance evaluation in the comingyears?

YesNo

*

*

*

*

35

114. Have you encountered any problems while carrying out the substance evaluation?YesNo

If yes, please specify:

Lack of human resources.

Theme 8: Annex XV Dossiers (restriction and identification of SVHC)and other points related to the identification of SVHC

Annex XV Restriction Dossiers

*115. Has the Member State been involved in the preparation of Annex XV Restriction Dossiers

within the reporting period?

YesNo

Annex XV SVHC Dossiers

*131. Has the Member State been involved in the preparation of Annex XV SVHC Dossiers?

YesNo

Other points related to the identification of SVHC

145. Do you consider that there is enough coordination between ECHA and Member States duringthe implementation of the SVHC Roadmap?

YesNo

*

*

36

146. What were the financial and human resources dedicated to SVHCs identification (bothscreening and preparation of an Annex XV dossier) before and after the agreement on theSVHCs Roadmap in March 2013?

Five people involved in screening. No differences before and after the

agreement of the roadmap.

Theme 9: Information on REACH enforcement activities

General information

*147. Please explain how the enforcement of REACH is organised in your country; please

concentrate on the changes from the last reporting:

For a definition of 'enforcement', please refer to the glossary.

No relevant changes have been made in the REACH enforcement organization

during this period. The Spanish Penalties Regime Law (Ley 8/2010, de 31

de marzo. BOE 1 de abril de 2010) states that the responsibility for

REACH enforcement in Spain lies with the regional authorities

(Autonomous Communities). Each of them has its own legal arrangements to

organise enforcement. The two Spanish MSCAs ensure the coordination

between all Spanish Enforcement Authorities.

*148. Are the national enforcement authority(ies) in charge of REACH, only dealing with REACH?

YesNo

*If No, what are their additional responsibilities?

There are not enforcement authorities (EAs) at national level.

Responsibilities are different depending on the Autonomous Community,

but most of the EAs belong to the regional public health

administrations. Additional responsibilities are usually related with

prevention of public health, such us the enforcement of biocides

legislation, prevention of legionella, detergents and cleaners specific

legislation, drinking water legislation, food hygiene, etc. Furthermore,

in some autonomous communities, environmental EAs cooperate with public

health EAs for the enforcement of REACH.

*

*

*

37

149. Describe the general status of the resources allocated to enforcing authorities for tasksrelated to the enforcement of REACH (assessment of annual budget and staff):1,800 character(s) maximum

Resources are highly variable depending on the regional enforcement

Authority. Almost all enforcement authorities share the resources and

staff with other activities related with public health protection. In

general, no specific REACH units have been established and the extensive

body of public health inspectorates has gradually incorporated REACH in

their general activities. This is also applied to existing Environmental

EAs.

Enforcement Strategy(ies)

General information on the enforcement strategy (or strategies) in place within the MemberState

*150. Has an overall strategy been devised and implemented for the enforcement of REACH?For a definition of 'enforcement', please refer to the glossary.

Yes devisedYes implementedNo

*151. Is(are) the strategy(ies) in line with the strategy devised by the Forum?

Forum strategy as described in the document “Strategies for enforcement of Regulation (EC) No. 1907/2006 concerning

the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and of Regulation (EC) No. 1272/2008

on the classification, labelling and packaging of substances and mixtures (CLP)” as adopted at the 9th meeting of the

Forum on 1-3 March 2011.

YesNo

*

*

38

*152. Please outline the enforcement strategy within the Member State:

In order to reach uniform, coordinated and effective enforcement, the

Spanish Penalties Regime Law establishes that all authorities shall

supply and share criteria, information and any other issue useful for

the normal application of their duties. In this cooperation, policy

objectives and priorities are defined. It includes the results of the

inspections, investigations and formal enforcements in an annual basis.

In the scope of Health Administration, a “National Network for

Surveillance, Inspection and Enforcement” is assigned, allowing

Enforcement Authorities to disseminate obtained data, to alert the rest

of Autonomous Communities of any risk when it is deemed necessary and

compile all the information available in order to decide how it can be

used. On the other hand, in the scope of Environment Administration, the

Law puts in place the network called “Conferencia Sectorial de Medio

Ambiente” and “Red de Directores Generales de Calidad y Evaluación

Ambiental”. In addition, the Spanish REACH Penalties Law establishes

that proposals and projects coming from the ECHA Forum should be

specially taken into account in the activities related with inspections

and enforcement of REACH. The Ministry of Health, Social Policy and

equality has coordinated REACHEN-FORCE projects in Spain. It is also

the designed point of contact for communication between other Member

states.

Annual programmes for targeting sectors to be inspected are established

by some EAs. Regular training is also included in the strategies.

*153. What type of activities does this strategy entail?

At national level, regular meetings between Competent Authorities for

the implementation of REACH (Ministry of Health and Social Policy and

Ministry of the Environment and Rural and Marine Affairs) are organized.

Also regular meetings between the Competent Authorities for the

implementation of REACH and enforcement competent authorities are

established. Those meetings includes activities such us organization of

joint trainings for inspectors or coordination of European inspection

projects (REACH-EN-FORCE, pilot projects, etc.)

At regional level, 9 of the 17 autonomous communities (regions) have

communicated the development of individual enforcement strategies

according to their industry characteristics and resources. Priorities on

the EA strategies are usually focused on raising awareness of REACH

obligations to the Industry, performing enforcement campaigns and

investigating situations of complains. Activities for training

inspectors or industry have also been outlined. The development of a

census of companies affected by REACH has been carried out by some EAs.

One of the autonomous communities has a regional helpdesk service

available for the stakeholders; which received 73 enquiries in 2013 and

64 enquiries in 2014.

*

*

39

*154. Is this enforcement strategy publicly available?

YesNo

*Please provide the link:

Three EA have provided the following links:

http://salutweb.gencat.cat/ca/ambits_tematics/per_perfils/empreses_i_est

abliments/empreses_que_fabriquen_comercialitzen_utilitzen_productes_quim

ics/reach/estrategia_govern_aplicacio_reach/

http://www.madrid.org

http://juntadeandalucia.es/export/drupaljda/programa_seguridad_quimica.p

df

Inspection strategy

156. Describe the REACH inspection strategy:

For a definition of 'inspection', please refer to the glossary.

At national level inspections strategy is focused on Forum projects. The

training of inspectors is also an important activity since REACH entered

into force.

*157. How has the inspection strategy evolved from 2010 to 2014?

During this period, Spain has participated on REACH EN FORCE 2 and 3. A

number of cases has been communicated between the Spanish EAs through

the “Fast Information Exchange System for chemicals”

*

*

*

40

757

*158. Does your inspection strategy consider the enforcement strategy developed by the FORUMand the activities carried out there?Forum strategy as described in the document “Strategies for enforcement of Regulation (EC) No. 1907/2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and of Regulation

(EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP)” as adopted at

the 9th meeting of the Forum on 1-3 March 2011.

YesNo

Please provide examples:

The development of the enforcement strategies have been carried out

taking into account mainly the objectives of REACH-EN-FORCE projects.

159. Please provide the total number of inspectors that attended training on REACH in yourMember States in the reporting period (2010-2014)?

Co-ordination, co-operation and exchange of information

Explanation of the co-ordination, co-operation and exchange of information, between enforcingauthorities, with Competent Authorities and other authorities from other Member States

*

41

*160. Please outline the mechanisms/procedures put in place to ensure cooperation, coordinationand exchange of information on REACH enforcement between enforcing authorities and otherauthorities (within or outside your Member State):

At national level, the main mechanisms are defined in the Spanish

Penalties Regime Law (Ley 8/2010): Article 3 is dedicated to information

exchange between Autonomous Communities and Competent authorities. Both

Spanish MSCAs and Spanish Enforcement authorities shall provide and

share criteria, information or any other mechanism available in order to

carry out their duties in a correct way. In the scope of Health

Administration, the Law establishes that, to ensure the dissemination of

sanitary alerts between Enforcement authorities, a “Fast Information

Exchange System for chemicals” has to be used. This system forms part of

the previously mentioned “National Network for Surveillance, Inspection

and Enforcement” and it has been working actively before CLP came into

force. Moreover, the Law establishes that other measures can be used in

order to achieve an effective coordination of actions to prevent risk

and the fulfilment of the Law. As it was mentioned before, all these

coordination activities are fulfilled by the “National Network for

Surveillance, Inspection and Enforcement” coordinated by the Ministry of

Health. Regarding the Environment Administration, the Law puts in place

the network called “Conferencia Sectorial de Medio Ambiente” and “Red de

Directores Generales de Calidad y Evaluación Ambiental” coordinated by

the Ministry of Environment.

Annually, all Enforcement authorities shall share the information of

activities carried out for the fulfilment of the Law.

At European level Spanish authorities follow the recommendation made by

Forum guidance for enforcement interlinks. Communication between Member

States is established using RIPE platform with a designed contact Focal

Point.

*

42

*161. Describe how these mechanisms have operated in practice during the reporting period (e.g.

regular meetings, joint training, joint inspections, co-ordinated projects and so on):

At national level:

- Regular meetings between Competent Authorities for the implementation

of REACH (Ministry of Health and Social Policy and Ministry of

Agriculture, Food and Environment). Specific meetings with other

national authorities (such as Customs) have also been organized.

- Regular meetings between the Competent Authorities for the

implementation of REACH and Enforcement Competent authorities.

- Organization of joint trainings for inspectors.

- Co-ordination of inspection projects (REACH-EN-FORCE and pilot

projects)

Concerning communication between Member States, four alerts from other

European countries have been received and inspected by Spanish

Enforcement authorities due to situations of REACH incompliance

affecting Spanish companies. Spain informed to other Member States about

three cases were companies from other countries were involved in an

investigation. Most of the communications were made using RIPE platform,

but in some cases, e-mails were also used.

*162. From Forum activities, which ones do you consider most relevant to enhance coordination,

cooperation and exchange of information among Member States:

European enforcement projects are essential for improving the

coordination among Member States. Also the implementation of

communication tools and written procedures are very important for a

practical cooperation. Also Forum meetings are very useful for improve

harmonization of REACH enforcement in EEE.


*

*

43

*163. Provide details on enforcement activities carried out with other Member States outside the

remit of the Forum:

No other activities have been carried out with other Member States

outside the remit of the Forum, apart from incompliance communications

described in question 161.

164. Describe any other measures/relevant information:

For a definition of 'measure', please refer to the glossary.

Data included in the report (2010-2014 Reporting on enforcement

activities) is based on the information provided by the regional

Enforcement Authorities. Not all EA have been able to provide

information for all questions or years. Therefore the results in some

cases could not be representative of the real situation.

2010-2014 Reporting on enforcement activities

Number of dutyholders

165. Provide an estimate of the total number of dutyholders who are likely to have duties imposedon them by REACH:

For a definition of 'dutyholder' please refer to the glossary.

The dutyholder principal role is the highest position the dutyholder has within the supply chain. For example, if a

manufacturer of a substance is also a downstream user of others, then its principal role should be regarded as

manufacturer.

If no information is available for a specific year, please indicate N/A in the corresponding box

2010 2011 2012 2013 2014

Number ofdutyholders 6500 7500 9000 9000 7000

*

44

166. Provide an estimate of the above dutyholders who are likely to be considered as registrantsas defined by REACH:


2010 2011 2012 2013 2014

Number ofdutyholders 1200 1200 1200 N/A N/A

*167. What was the total number of official controls such as inspections or investigations ormonitoring, or other enforcement measures carried out by enforcing authorities in which REACHwas covered and/or enforced during the reporting period?For definitions of 'investigation' or 'monitoring', please refer to the glossary.

14564

*

45

*168. State the number of subject to enforcement activities:manufacturers


2010 2011 2012 2013 2014

Number of manufacturers 92 281 356 167 181

*

46

Were these mainly:

For definitions of micro, small and medium-sized enterprises, please refer to the glossary.

The category 'not applicable' can be filled in case you have information on the size of industry but it does not

allow you to complete the three categories (Small, Medium, Large).

Micro Small Medium Large No information N/a

*2010

*2011

*2012

*2013

*2014

*

*

*

*

*

47

*169. State the number of subject to enforcement activities:only representatives


2010 2011 2012 2013 2014Number of only representatives 0 0 0 13 13

*

48

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*170. State the number of subject to enforcement activities:distributors


2010 2011 2012 2013 2014

Number ofdistributors 443 769 1355 632 379

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

*

*

49

*171. State the number of subject to enforcement activities:downstream users


2010 2011 2012 2013 2014

Number ofdownstream users 653 1457 2145 2028 1928

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*172. State the number of subject to enforcement activities:importers

If no information is available for a specific year, please indicate N/A in the corresponding box.

2010 2011 2012 2013 2014

Number of importers 11 23 42 99 76

*

*

*

*

*

*

*

50

Were these mainly:


*2010

*2011

*2012

*2013

*2014

Number of official controls prompted by…

*173. Have there been complaints or concerns received by enforcing authorities in relation to

alleged contraventions of the REACH Regulation?

Controls are understood as inspections or investigations or monitoring, or other enforcement measures carried

out by enforcing activities.


2010 2011 2012 2013 2014

Number of controls 25 23 47 169 233

*174. Incidents (e.g. accidents such as poisoning or other dangerous occurrences)?


2010 2011 2012 2013 2014


*175. Monitoring activities?


2010 2011 2012 2013 2014


*

*

*

*

*

*

*

*

51

*176. Results of an inspection?


2010 2011 2012 2013 2014


Number of official controls which addressed…

*177. Registration:




2010 2011 2012 2013 2014


Cases ofnon-compliancefound

0 0 0 13 5

*178. Registration and notification of substances in Articles:


2010 2011 2012 2013 2014



0 0 0 0 0

*179. Information in the supply chain:


2010 2011 2012 2013 2014



22 145 62 584 248

*

*

*

*

52

*180. Duty to communicate information on substances in articles:


2010 2011 2012 2013 2014



0 0 0 0 0

*181. Restrictions:


2010 2011 2012 2013 2014



0 0 6 21 2

*182. Authorisations:


2010 2011 2012 2013 2014



0 0 0 0 0

*183. Imported goods:If no information is available for a specific year, please indicate N/A in the corresponding box.

2010 2011 2012 2013 2014



0 0 0 0 0

Number of official controls which resulted in...

*

*

*

*

53

*184. No areas of infringement found:


2010 2011 2012 2013 2014

Number of controls N/A 53 73 422 387

*185. Verbal or written advice:


2010 2011 2012 2013 2014


*186. Legal proceedings:


2010 2011 2012 2013 2014


*187. Convictions:


2010 2011 2012 2013 2014


188. Other:If no information is available for a specific year, please indicate N/A in the corresponding box.

2010 2011 2012 2013 2014


If 'Other', please specify:

*

*

*

*

54

0

0

189. Please provide information on difficulties encountered during REACH official controls:

Some EA stated that, due to the complexity of the legislation, it

requires high level specialized inspectors with good training. There are

also difficulties with the low knowledge of REACH legislation from

affected companies, specially SME and intermediate users.

190. Please provide information on good practices related to REACH official controls:

Sanctions

191. Describe the different sanctions that can be used in case of contravention of REACH, e.g.enforcement notices and other sanctions such as on-the-spot fines or undertakings, officialreprimands such as formal cautions or warnings, and legal proceedings (whether criminal or civilin nature):The answer to this question is to be given only if the position has changed since the last reporting period.

No changes have been made in the reporting period

Appeals

192. Please state the number of appeals against REACH enforcement National EnforcementAuthority decisions in your Member State in the reporting period (2010 – 2014):

193. Please state the number of REACH enforcement National Enforcement Authority decisions inyour Member State that were overturned by ruling of a domestic or EU court of law in thereporting period (2010-2014):

Theme 10: CLP enforcement activities

55

General information

*194. Please explain how competent authorities are organised for the enforcement of CLP in your

country; please concentrate on the changes from the last reporting:


No relevant changes have been made in the CLP enforcement organization

during this period. The Spanish Penalties Regime Law (Ley 8/2010, de 31

de marzo. BOE 1 de abril de 2010) states that the responsibility for CLP

enforcement in Spain lies with the regional authorities (Autonomous

Communities). Each of them has its own legal arrangements to organise

enforcement. The two Spanish MSCAs ensure the coordination between all

Spanish Enforcement Authorities.

*195. How many authorities are in charge of CLP enforcement? Please provide their names:

Each Autonomous Community has its own enforcement structure. In Spain

there are 17 different autonomous communities.

196. Describe the general status of the resources allocated to enforcing authorities for tasksrelated to the enforcement of CLP (assessment of annual budget and staff):1,800 character(s) maximum

Resources are highly variable depending on the regional enforcement

Authority. Almost all enforcement authorities share the resources and

staff with other activities related with public health protection. In

general, no specific CLP units have been established and the extensive

body of public health inspectorates has gradually incorporated CLP in

their general activities. This is also applied to existing Environmental

EAs.

Enforcement Strategy(ies)

General information on the enforcement strategy (or strategies) in place within the MemberState

*197 Has an overall strategy or strategies been implemented for the enforcement of the CLPRegulation?

YesNo

*

*

*

56

*198. Is(are) the strategy(ies) in line with the strategy devised by the Forum?Forum strategy as described in the document “Strategies for enforcement of Regulation (EC) No. 1907/2006




YesNo

*199. Please outline the enforcement strategy within the Member State, and themethodology/techniques used (this should include a description of the criteria by whichdutyholders were selected for enforcement activities):

In order to reach uniform, coordinated and effective enforcement, the

Spanish Penalties Regime Law establishes that all authorities shall

supply and share criteria, information and any other issue useful for

the normal application of their duties. In this cooperation, policy

objectives and priorities are defined. It includes the results of the

inspections, investigations and formal enforcements in an annual basis.

In the scope of Health Administration, a “National Network for

Surveillance, Inspection and Enforcement” is assigned, allowing

Enforcement Authorities to disseminate obtained data, to alert the rest

of Autonomous Communities of any risk when it is deemed necessary and

compile all the information available in order to decide how it can be

used. On the other hand, in the scope of Environment Administration, the

Law puts in place the network called “Conferencia Sectorial de Medio

Ambiente” and “Red de Directores Generales de Calidad y Evaluación

Ambiental”. In addition, the Spanish CLP Penalties Law establishes that

proposals and projects coming from the ECHA Forum should be specially

taken into account in the activities related with inspections and

enforcement of REACH. The Ministry of Health, Social Policy and equality

has coordinated REACHEN-FORCE projects in Spain. It is also the designed

point of contact for communication between other Member states.

Annual programmes for targeting sectors to be inspected are established

by some EAs. Usually, CLP is also taken into account when other

programmes for different public health legislation are elaborated.

Regular training is also included in the strategies.

*

*

57

*200. Provide information on the level and extent of monitoring activities undertaken (this shouldinclude a description of the criteria by which substances, mixtures, articles etc. were selected formonitoring):For a definition of monitoring activities, please refer to the glossary.

Each regional EA apply it own criteria for selection and the extent of

CLP monitoring activities. Normally the criteria is based on the risks

according the classification and production quantities of the dangerous

substances and mixtures. Other criteria for selection are based on

campaigns for specific markets (cleaners, paints, etc.) or type users

(professionals, consumers). For instance, some Enforcement Authorities

included in the prioritization substances included in the SVHC list

(especially CMR substances). Companies or substances with previous

situations of non-compliance were also prioritized. Furthermore, in some

E.A. there have been activities where the requirement for the

presentation of the SDS were used as base for checking if they substance

was correctly classified and labelled according CLP. Also application of

other Spanish legislation, such as the authorisation of substances for

drinking water, was used as a base for verifying the correct application

of CLP.

*201. Is this enforcement strategy publicly available?

YesNo

*Please provide the link:

Three EA have provided the following links:

http://salutweb.gencat.cat/ca/ambits_tematics/per_perfils/empreses_i_est

abliments/empreses_que_fabriquen_comercialitzen_utilitzen_productes_quim

ics/reach/estrategia_govern_aplicacio_reach/

http://www.madrid.org

http://juntadeandalucia.es/export/drupaljda/programa_seguridad_quimica.p

df

Inspection Strategy

*

*

*

58

1357

203. Describe the CLP inspection strategy:

For a definition of 'inspection', please refer to the glossary.

At national level, the inspection strategy is mainly base on Forum

projects. Inspections are also performed by the EA from alerts received

through the Spanish network “Fast Information Exchange System for

chemicals” or as result of information exchange between other European

enforcement authorities.

At regional level, EAs have annual programmes for the development of

routine inspections. In many cases, CLP inspections are included as part

of the inspection programmes of other legislation such us REACH or

biocides.

*204. How has the inspection strategy evolved from 2011 to 2014?

The participation in REACH EN FORCE 2 during 2011 has influenced the

annual programmes of the regional EA for the following years.

Nevertheless, in some regions, the lack of economic resources has

affected the strategy. The number of cases communicated between the

Spanish EAs through the “Fast Information Exchange System for chemicals”

has also slightly increased during this period.

*205. Does your inspection strategy consider the enforcement strategy developed by the FORUMand the activities carried out there?Forum strategy as described in the document “Strategies for enforcement of Regulation (EC) No. 1907/2006




YesNo


REACH-EN-FORCE projects, interlinks and communication tools (RIPE),

training, etc.

206. Please provide the total number of inspectors that attended training on CLP in your MemberState in the reporting period (2011-2014):

*

*

59

Co-ordination, co-operation and exchange of information

Explanation of the co-ordination, co-operation and exchange of information, between enforcingauthorities, with Competent Authorities and other authorities from other Member States

*207. Please outline the mechanisms/procedures put in place to ensure cooperation, coordination

and exchange of information on CLP enforcement between enforcing authorities and otherauthorities (within or outside your Member State):

At national level, the main mechanisms are defined in the Spanish

Penalties Regime Law (Ley 8/2010): Article 3 is dedicated to information

exchange between Autonomous Communities and Competent authorities. Both

Spanish MSCAs and Spanish Enforcement authorities shall provide and

share criteria, information or any other mechanism available in order to

carry out their duties in a correct way. In the scope of Health

Administration, the Law establishes that, to ensure the dissemination of

sanitary alerts between Enforcement authorities, a “Fast Information

Exchange System for chemicals” has to be used. This system forms part of

the previously mentioned “National Network for Surveillance, Inspection

and Enforcement” and it has been working actively before CLP came into

force. Moreover, the Law establishes that other measures can be used in

order to achieve an effective coordination of actions to prevent risk

and the fulfilment of the Law. As it was mentioned before, all these

coordination activities are fulfilled by the “National Network for

Surveillance, Inspection and Enforcement” coordinated by the Ministry of

Health. Regarding the Environment Administration, the Law puts in place

the network called “Conferencia Sectorial de Medio Ambiente” and “Red de

Directores Generales de Calidad y Evaluación Ambiental” coordinated by

the Ministry of Environment.

Annually, all Enforcement authorities shall share the information of

activities carried out for the fulfilment of the Law.

At European level Spanish authorities follow the recommendation made by

Forum guidance for enforcement interlinks. Communication between Member

States is established using RIPE platform with a designed contact Focal

Point.

*

60

*208. Describe how these mechanisms have operated in practice during the reporting period (e.g.regular meetings, joint training, joint inspections, co-ordinated projects and so on):

At national level:

- Regular meetings between Competent Authorities for the implementation

of REACH (Ministry of Health and Social Policy and Ministry of

Agriculture, Food and Environment). Specific meetings with other

national authorities (such as Customs) have also been organized.

- Regular meetings between the Competent Authorities for the

implementation of REACH and Enforcement Competent authorities.

- Organization of joint trainings for inspectors.

- Co-ordination of inspection projects (REACH-EN-FORCE and pilot

projects)

Concerning communication between Member States, three alerts from other

European countries have been received and inspected by Spanish

Enforcement authorities due to situations of CLP incompliance affecting

Spanish companies. Spain informed to other Member States about two cases

were companies from other countries were involved in an investigation.

Most of the communications were made using RIPE platform, but in some

cases, e-mails were also used.

2011-2014 Reporting on enforcement activities

*209. What was the total number of official controls, such as inspections or investigations, or otherenforcement measures carried out by enforcing authorities in which CLP was covered and/orenforced during the reporting period?For a definition of 'inspection' and 'investigation', please refer to the glossary.

2011 2012 2013 2014

Number of controls 828 2886 3391 3322

210. If applicable, please add a description of the other enforcement measures carried out in thisreporting period:


Number of dutyholders

*

*

61

211. Provide an estimate of the total number of dutyholders who are likely to have duties imposedon them by CLP:

For a definition of 'dutyholder', please refer to the glossary.

The dutyholder principal role is the highest position the dutyholder has within the supply chain. For example, if a

manufacturer of a substance is also a downstream user of others, then its principal role should be regarded as

manufacturer.


2011 2012 2013 2014

Number ofdutyholders N/A 1200 5000 4500

Dutyholders subject to official controls

*212. State the number of subject to enforcement activities under CLP:manufacturers


2011 2012 2013 2014

Number ofmanufacturers 61 930 159 169

Were these mainly:

For definitions of micro, small and medium-sized enterprises, please refer to the glossary.

The category not applicable can be filled in case you have information on the size of industry but it does not allow

you to complete the three categories (Small, Medium, Large).


*2011

*2012

*2013

*2014

*

*

*

*

*

62

*213. State the number of subject to enforcement activities under CLP:distributors


2011 2012 2013 2014

Number ofdistributors 109 85 695 542

Were these mainly:


*2011

*2012

*2013

*2014

*214. State the number of subject to enforcement activities under CLP:downstream users


2011 2012 2013 2014

Number ofdownstream users 299 882 2309 1923

*

*

*

*

*

*

63

Were these mainly:


*2011

*2012

*2013

*2014

*215. State the number of subject to enforcement activities under CLP:importers


2011 2012 2013 2014

Number of importers 19 115 100 66

Were these mainly:


*2011

*2012

*2013

*2014

Number of official controls prompted by…

*

*

*

*

*

*

*

*

*

64

*216. Have there been complaints or concerns received by enforcing authorities in relation to

alleged contraventions of the CLP Regulation?




2011 2012 2013 2014


*217. Incidents (e.g. accidents such as poisoning or other dangerous occurrences)?


2011 2012 2013 2014


*218. Monitoring activities?


2011 2012 2013 2014


*219. Results of an inspection?


2011 2012 2013 2014


Number of official controls which addressed…

*220. Hazard classification:


2011 2012 2013 2014



14 31 51 42

*

*

*

*

*

65

*221. Hazard communication in the form of labelling:


2011 2012 2013 2014



55 123 197 164

*222. Packaging:


2011 2012 2013 2014



3 3 2 3

*223. Harmonisation of classification and labelling of substances:


2011 2012 2013 2014


Cases ofnon-compliance found 3 4 30 18

*224. Notification to the classification and labelling inventory according to Article 40:


2011 2012 2013 2014



7 1 0 0

*

*

*

*

66

*225. Other common provisions, such as the obligation to maintain information and requests for

information:


2011 2012 2013 2014



*226. Imported goods:If no information is available for a specific year, please indicate N/A in the corresponding box.

2011 2012 2013 2014

Number of controls N/A 1 1 1


*227. Other CLP obligations:


2011 2012 2013 2014



2 0 9 27

Number of official contols which resulted in...

*228. No areas of infringement found:


2011 2012 2013 2014


*229. Verbal or written advice:


2011 2012 2013 2014


*

*

*

*

*

67

*230. Legal proceedings:


2011 2012 2013 2014


*231. Convictions:


2011 2012 2013 2014


232. Other:

2011 2012 2013 2014


If 'Other', please specify:

Sanctions

233. Describe the different sanctions that can be used in case of contravention of the CLPRegulation, e.g. enforcement notices and other sanctions such as on-the-spot fines orundertakings, official reprimands such as formal cautions or warnings, and legal proceedings(whether criminal or civil in nature):

The answer to this question needs only be given if the position has changed since the last reporting period or is

different to that provided by virtue of CLP Article 47.

No changes have been made in the reporting period

Appeals

*

*

68

234. Please state the number of appeals against CLP enforcement National EnforcementAuthority decisions in your Member State in the reporting period (2011 – 2014):

235. Please state the number of CLP enforcement National Enforcement Authority decisions inyour Member State that were overturned by ruling of a domestic or EU court of lawNew NumberQuestion in the reporting period (2011 – 2014):

Other enforcement activity not covered elsewhere

236. Provide details on enforcement activities carried out at the request / suggestion of ECHA:

No requested/suggested activities have been received by ECHA a part of

SONCs (REACH)

237. Provide details on enforcement activities carried out at the request of other Member States,e.g. where cross-border issues are detected and communicated:

During this period, we received four communications from three Member

states (The Netherlands, Germany and U.K.) indicating non compliances

with the classification or labelling of products marketed by Spanish

companies. All cases were enforced by the correspondent regional EA.

Spain sent two incompliances (to Portugal and Italy) regarding mixtures

with wrong classification.

238. Detail any other measures taken pursuant to articles 46(1) and 47 of the CLP Regulation, orany other information you wish to provide for the purposes of this part of the Report:For a definition of 'measure', please refer to the glossary.

Data included in the report (2011-2014 Reporting on enforcement

activities) is based on the information provided by the regional

Enforcement Authorities. Not all EA have been able to provide

information for all questions or years. Therefore the results in some

cases could not be representative of the real situation.

Theme 11: Information on the effectiveness of REACH on theprotection of human health and the environment, and the promotionof alternative methods, and innovation and competition

69

239. Do you think that the effects of REACH would be better evaluated at a Member State or atEU level?

Member State levelEU level

240. Please provide a brief explanation of your response:


The effects of REACH to the protection of human health and environment

apply to all Member states and therefore the evaluation of the effects

should be done equally at EU level.

241. What parameters are available at Member State level that could be used to assess theeffectiveness of REACH in a baseline study?


Theme 12: Other issues / recommendations / ideas

242. Please provide any further information on the implementation of REACH that the MemberState considers relevant:


*243. Do you wish to upload documents in support of this submission?

YesNo

You may upload one or more documents.

*

70

Background DocumentsGlossary (/eusurvey/files/457b4be8-39e0-4dc4-87ba-703092ec1ddb)

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