member states reporting under reach art. 117 / clp art · 2015. 11. 11. · 1 case id:...

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Case Id: 87e6f17f-61a5-4898-a56e-e51577fd6c6dDate: 20/07/2015 14:25:33

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

Fields marked with * are mandatory.

Introduction

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?

Ireland

*2. Primary contact person's name

Cliona Ryan

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

[email protected]

Theme 1 - Information on the Competent Authority

*

*

*

2

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)

There are three Competent Authorities responsible for the operation of

the REACH Regulation within the State: 1. The Health and Safety

Authority – The lead Competent Authority with responsibilities which

include the general enforcement of the REACH Regulation requirements,

the provision of helpdesk services, participation in REACH and EChA

committees, and general supervision of actions of other Competent

Authorities within the State; 2. The Minister for Agriculture, Fisheries

and Food in respect of pesticides; and 3. The Environmental Protection

Agency in respect of the prevention of environmental pollution.

*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.

3

One / First Competent Authority Responsible for REACH

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

Health and Safety Authority

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

Metropolitan Building, James Joyce Street, Dublin 1

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

[email protected]

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

0035316147000

*

*

*

*

*

3

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

AllEvaluationRisk AssessmentHelpdeskAuthorisationRestrictionRegistrationOther

*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:

There are 7.5 FTE staff members who are involved in the implementation

of REACH (and CLP) as part of their overall remit.

*

*

*

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 1.5

Ecotoxicologist 0Chemist 0

Exposure Assessor 0.4Risk Assessor 2

Risk manager 0.2

Economist 0

IT 0.3

Communication 1.2

Other 0

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

No. Due to resource constraints within the Authority, there is presently

no expertise in-house in relation to chemistry and ecotoxicology.

*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

*If Other, please list the different legislations here:

Detergents Regulation, Chemical Agents Directive, Carcinogens/Mutagens

Directive, Asbestos Directive, Seveso Directive, Chemical Weapons,

Biological Agents Directive, Dangerous Preparations Directive

*17. Are there any other institutions (agency, institute, regional authorities) that the CompetentAuthority works with in relation to REACH issues?

YesNo

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

The Department of Jobs, Enterprise and Innovation (DJEI)

The Department of Agriculture, Fisheries and the Marine (DAFM)

The Environmental Protection Agency (EPA)

The Department of Environment, Heritage & Local Government

The Revenue Commissioners - Customs Authorities

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

YesNo

*

*

*

*

*

6

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

To external consultants with expertise on physico-chemical, human health

and environmental endpoints for hazard and exposure assessments in

relation to Substance Evaluation.

*And on what type of expertise is outsourced:

Environmental exposure assessment, environmental hazard assessment,

phys-chemical hazard assessment, inhalatory toxicology expertise.

*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

*20. Does the Competent Authority have appropriate technical resources (understood in terms ofexpertise, skills and competences of the staff)?

12345

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

12345

*

*

*

*

*

7

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

Second Competent Authority responsible for REACH

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

The Environmental Protection Agency

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

P.O. Box 3000, Johnstown Castle Estate, Wexford, Ireland

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

[email protected]

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

00353539160600

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


*

*

*

*

*

8

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


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

1 Part-time member of staff (~0.2FTE).

*13b. Do you have specialised staff in the following categories? Please quantify these skills inFTE (Full Time Equivalent).


Number of FTE

Toxicologist 0


Exposure Assessor 0Risk Assessor 0

Risk manager 0

Economist 0

IT 0

Communication 0

Other ~0.2FTE

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

No

*

*

*

*

9

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

YesNo

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



*If Other, please list the different legislations here:

Directive 2011/65/EU of the European Parliament and of the Council of 8

June 2011 on the restriction of the use of certain hazardous substances

in electrical and electronic equipment (recast); Directive 2006/66/EC of

the European Parliament and of the Council of 6 September 2006 on

batteries and accumulators and waste batteries and accumulators and

repealing Directive 91/157/EEC (specified restricted substances

essential requirements); Directive 2004/42/CE of the European Parliament

and of the Council of 21 April 2004 on the limitation of emissions of

volatile organic compounds due to the use of organic solvents in certain

paints varnishes and vehicle refinishing products and amending Directive

1999/13/EC.

*17b. Are there any other institutions (agency, institute, regional authorities) that the CompetentAuthority works with in relation to REACH issues?

YesNo

*

*

*

*

10


Health and Safety Authority of Ireland - Lead Competent Authority for

the REACH Regulation within the State

Competition and Consumer Protection Commission of Ireland - For the

purposes of following up RAPEX notifications relating to contraventions

of the REACh Regulation posing a serious environmental risk.

*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:

The Environmental Protection Agency outsources suitably qualified

personnel for certain aspects of follow-up inspections for RAPEX

notifications relating to contraventions of the REACH Regulation posing

a serious enviornmental risk.

*And on what type of expertise is outsourced:

The Environmental Protection Agency does not currently outsource

expertise in relation to REACH Regulation requirements. Suitably trained

personnel are contracted to carry out follow-up inspections for RAPEX

notifications relating to contraventions of the REACH Regulation posing

a serious environmental risk,

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



12345

*

*

*

*

*

11

*20b. Does the Competent Authority have appropriate technical resources (understood in terms ofexpertise, skills and competences of the staff)?

12345

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

12345

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

No further comments.

Third Competent Authority responsible for REACH

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

Department of Agriculture, Food & the Marine

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

Pesticide Registration and Control Divisions, DAFM Laboratories,

Backweston Campus, Young's Cross, Celbridge, Co Kildare, Ireland

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

[email protected]

*

*

*

*

*

12

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

0035316157552

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


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

Pesticides

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


*If Other, please list the other part of Government the Competent Authority gets authority from:

Department of Agriculture, Food & the Marine

*

*

*

*

*

13

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

There are currently 27 staff in the Pesticide Registration and Control

Divisions whose work may include aspects that cover the implementation

of REACH.

*13c. Do you have specialised staff in the following categories? Please quantify these skills inFTE (Full Time Equivalent).


Number of FTE

Toxicologist 4


Exposure Assessor 0Risk Assessor 0

Risk manager 4

Economist 0

IT 0

Communication 0

Other 0

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

Yes

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

YesNo

*

*

*

*

14

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



*17c. Are there any other institutions (agency, institute, regional authorities) that the CompetentAuthority works with in relation to REACH issues?

YesNo


Department of Jobs, Enterprise and Inovation

Health and Safety Authority of Ireland

Environmental Protection Agency, Ireland

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

YesNo

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



12345

*

*

*

*

*

15

*20c. Does the Competent Authority have appropriate technical resources (understood in terms ofexpertise, skills andcompetences of the staff)?

12345

*21c. Does the Competent Authority have appropriate human resources (understood in terms ofnumber of staff)?

12345

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

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 beimproved?

1800 character(s) maximum

DAFM: No comment

Health and Safety Authority: communication works effectively at present.

*

*

*

16

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


DAFM: No comment

HSA: No comment

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


DAFM: No comment.

HSA: We appreciate the efforts made by ECHA to-date to ensure robust and

transparent communication with Member States. We would ask for this to

continue and for particular effort to be paid to ensuring written

communication is clear, timely, unambiguous and free from acronyms and

jargon whenever possible.

*26. How could the exchange of information and dialogue between Member States and theCommission be improved?


DAFM: No comment

HSA: As with our request to ECHA, we would ask that written

communication is clear, timely, unambiguous and free from acronyms and

jargon whenever possible.

Theme 3: Operation of the national helpdesk

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


*

*

*

*

17

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

Metropolitan Building, James Joyce Street, Dublin 1, Ireland

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

www.hsa.ie/chemicals

*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)?

1890289389

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

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

*

*

*

*

*

18

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

Number of FTE

Toxicologist 0.2

Ecotoxicologist 0

Chemist 0

Exposure Assessor 0.1

Risk Assessor 0.1

Risk manager 0.1

Economist 0

IT 0

Communication 0.8

Other 0

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

YesNo

*If 'no', please specify what expertise is missing:

a chemist for substance i.d. or chemistry specific queries

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

Substance i.d.,

Data sharing disputes,

Legal interpretations,

Complicated legal entity change queries,

Substance specific queries

*

*

*

*

19

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


WebsiteNewsletterAdvice servicesTrainingsMediation / conflict resolutionOther

*If 'Other', please specify:

Seminars/presentations,

Publications,

Awareness raising campaigns

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

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:

We do not have specific mechanisms, as such. However, we do have a scope

document published on our website and follow a standard operating

procedure. We produce a monthly report for the management team. Answers

to difficult queries are discussed amongst staff and reviewed by senior

staff, where necessary. Helpex is then used where we are unsure of an

answer.

*

*

*

*

*

*

20

*41. Is ISO9000 norm in place?

YesNo

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

*

*

*

*

*

*

*

*

21

%0.3

%0.3

%6

%4

%0.2

%17

%100

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

*Data sharing

*

*

*

*

*

*

*

*

22

%1.85

%0.15

%2.75

%2.7

%4.3

%1.3

%16

%5.3

%0.9

%1.2

*Enforcement

*CSR preparation

*CLP Classification

*CLP Labelling

*CLP Packaging

*CLP Classification and labelling inventory

*SIEFs

*REACH-IT

*IUCLID5

*Downstream user obligations

*

*

*

*

*

*

*

*

*

*

23

%70

%30

%13.4

%1.6

%15

%3.75

%2

*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

*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

*

*

*

*

*

*

*

*

24

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

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

The REACH and CLP Helpdesks were merged. It was then decided to expand

the overall remit of the helpdesk and have one email address

([email protected]) to cover all chemical related queries, with the

queries allocated to staff accordingly. New recording mechanisms are in

place, allowing queries to be esaily searched, trends to be noticed,

etc.

*

*

*

*

*

*

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


For better cooperation, there needs to be more opportunity for the MS

NHDs to communicate with each other directly, currently all

communication is all done through ECHA and mostly only via HelpEx. If

such a mechanism is found, this in turn will lead to better cooperation.

For example, the working groups set up under HelpNet has proved very

useful for HelpNet members to get to know each other better, share their

expertise and to solve a particular issue or work task. The helpdesk

reports to ECHA often ask us to provide feedback on stakeholder

communication/events but we don’t really discuss the output from this

input. Are some MS doing a lot while other are doing nothing, can we

help each other more perhaps? A good example of cooperation was DE/

BAUA sharing its CLP posters with IE and SE and this subsequently went

to South Africa and Australia. Also, some NHDs are more experienced than

others, yet there is no way to share this expertise. ECHA have visited

most of the NHD’s, perhaps also there should be an opportunity for the

NHDs to visit each other. This too could prove to be very worthwhile.

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


A suggestion is that ECHA or COM compile a list of the relevant (perhaps

accredited stakeholder) Helpdesks, where they are, what their scope is,

who their sectors are, intended target audience etc. In this way it will

then be easier for these non HelpNet Helpdesks and the MS NHD to know

about each other, perhaps create opportunities for better cooperation

amongst each other and with NHDs. For example the EEN works well with

some MS NHDs but not so in others.

*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

*

*

26

*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:

*

*

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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

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

Single webpageMultiple webpages

*

*

*

*

*

*

*

*

*

*

*

*

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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 andvalidation of alternative test methods by participating in relevant committees?

YesNo

*68. What has been the overall public funding on research and development of alternative testingin your Member States each year?

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

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

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

*

*

29

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



12345

71. Please specify if needed:


Health and Safety Authority: The REF and pilot projects run by the Forum

are beneficial to the work of the Authority. The inspectors

participating gain valuable knowledge through the training provided by

the Forum and through focusing on the specific topic being addressed in

that project. The results from such projects also help to plan future

work within MSs.

However, the workload of the Forum is at times overwhelming with

numerous working groups (WG) on-going (at times up to 10). Therefore,

there is a resource constraint on the Forum due to a lack of available

Chairs and members for each WG.

It is also difficult for MSs to contribute continuously to the many

documents which are sent out for consultation/comment from each WG.

Workload for smaller MSs with reduced resources is an issue.

The work of the Forum must be firstly kept within it's remit and

secondly focused so that each MS regardless of it's size or resources

can contribute effectively and gain benefits from participation.

The remit of the Forum does not include work on the Biocides Regulation,

however, the RIPE WG has taken on the workload of scoping out RIPE for

the needs of biocides inspectors. Such work should not be taken on by

Forum WGs.

The work carried out by the Forum must be kept within the remit as set

out in Articles 77(4) and 46(3) of the REACH and CLP Regulations

respectively.

*

30

72. How could the effectiveness be improved?


The work of the Forum needs to be streamlined and focused with work

prioritised according to the remit of the Forum.

Working groups must only be formed where necessary and agreed by all

participating countries. The work of these WGs must be relevant for all

Forum members and must be kept within the remit of the Forum.

Consideration should be given to all activities carried out by the Forum

and how each piece of work will benefit members.

Annual Train the Trainers events should be held only for specific REF

and pilot projects, focusing Forums efforts on training inspectors in

practical issues which they are then actively involved in and can learn

by “doing”. This is a far more effective way of training and reduces the

need for further resources to be put into additional WGs/training

organisation for both Forum and ECHA.

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

12345



While the committee is effective, in reality there is very little room

left for manoeuvre at the point where a vote is taking place. The

opinion of the RAC and SEAC having already been taken into account in

the commission proposal.



As outlined in 74, decisions taken during earlier processes impact on

the ability of the REACH Committee to take effective decisions.

Discussions which take place at the EPG Meeting on REACH and CLP raise

important issues in relation to decisions taken but there is no

potential for these debates to influence.

*

31

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

12345





Further use of written procedures to seek agreement

Increased participation of all members although acknowledging resources

in home countries can be an issue for Member States.

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

12345

*

*

32



Both IE RAC Members rat the Commitee as '4'.

DAFM nominated expert response (CLH): Discussions at RAC involving

complex CLH endpoints such as CMR help greatly in understanding all the

relevant information provided by industry and dossier submitters when

evaluating a particular substance. A wealth of knowledge from a wide

variety of experts is drawn upon that can help to enhance the experience

of members returning to their respective MSCAs. In addition, data gaps

may be identified or industry may submit new studies or data during

public consultation of each substance on the agenda for discussion and

evaluation.

HSA Nominated Expert ( Authorisation & Restrictions):The Committee is

currently working well considering the volume of work it has completed

in terms of CLH, authorisation applications and restriction dossiers.

However, when acting as rapporteur it is difficult to also review all

the other opinions being drafted at the same time by other rapporteurs

so as to provide input and assistance to them in the opinion making and

to ensure consistency in approach to the scientific review and

assessment of dossiers. Concerns would be that as more and more

substances are added to Annex XIV with widespread uses that the volume

of opinions to be drafted might overburden the actual amount of

rapporteurs available.



DAFM response: The effectiveness of the RAC could be improved by

increasing the representation from Member State Competent Authorities,

and by increasing the time / staff resources for the tasks assigned to

RAC members at their home institutions.

HSA Response: In addition to the above, the RAC was established

including the number of representatives to be nominated per MS under the

REACH legislation. The Committee was established to undertake the roles

of scientific opinion making for applications for Authorisations &

Restriction proposals. Subsequently, the CLP Regulation was enacted

which assigned the role of hazard assessment on CLH proposal to RAC

without consideration of any additional resources to support this work.

It would be beneficial to have a separate Committee established for

Hazard Assessment.

33

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

12345





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

12345



HSA - The committee generally works well and has been streamlined to 2

days in recent years.

*

*

34



HSA - While welcoming the reduction in the length of the meeting, it is

important to ensure this reduction does not come at the cost of having a

robust and complete discussion as items arise on an agenda. Written

papers and issues should be provided in good time to ensure robust

discussions at each meeting with papers provided being clear and

unambiguous in their intent.

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

12345



Health and Safety Authority: This network is no longer active. We did

participate in the early days of the network.



N/A

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

12345

*

*

35

8

7

54





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 (excludingpresence in the Member State Committee)?

Please insert a figure.

*

*

*

*

36

2

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

YesNo

*99. Do you consider that the dossier evaluation process, as currently structured, has to dateserved its purpose?

YesNo

100. How could it be improved?


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

YesNo

If yes, please describe enforcement actions and results obtained:

3 statements of non-compliance were followed up with IE registrants.

Written advice was issued to the registrants in each case. One case has

been closed and the other 2 remain open for now (one will remain open

but no further enforcement action to be taken).

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.

*

*

*

*

*

37

15

52

*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:

Preparation of the substance evaluation report and preparation of the

text of the draft decision.

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):

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

YesNo

*

*

*

*

*

*

*

*

*

*

38

*If yes, please specify the expertise outsourced:

High level ecotox review,

Phys-chem review,

Specific human health expertise (inhalation toxicology)

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

YesNo

*110. Have you initiated any action under other REACH processes as a consequence ofsubstance evaluation performed by you or another Member States (e.g. Annex VI dossier forharmonised C&L, annex XV dossier for SVHC ID or restriction, other non-REACH regulatoryaction) within the reporting period?

YesNo

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

€80,000 - €100,000 based on salaries of staff involved, travel and

subsistence, external expertise used etc.

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

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

*

*

*

39

0

0

0

0

If yes, please specify:

Lack of expertise in certain areas.

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 Dossierswithin the reporting period?

YesNo

*116. How many Annex XV restriction dossiers has the Member State prepared within thereporting period?Please insert a figure.

*117. Among these how many were co-prepared with other Member States/ECHA?Please insert a figure.

*118. How many person-days were dedicated to the development of Annex XV restrictiondossiers?Please insert a figure.

*119. How many person-days were dedicated to the assessment of Annex XV restrictiondossiers?Please insert a figure.

*

*

*

*

*

40

1

3

0

8

*120. How many times a representative of your Member State has been nominated rapporteurunder the Risk Assessment Committee (RAC) within the reporting period?


*121. How many times a representative of your Member State has been nominated rapporteurunder the Socio-Economic Committee (SEAC) within the reporting period?


*122. How many times a representative of your Member State has been nominated co-rapporteurunder the Risk Assessment Committee (RAC) within the reporting period?


*123. How many times a representative of your Member State has been nominated co-rapporteurunder the Socio-Economic Committee (SEAC) within the reporting period?


*

*

*

*

41

124. What expertise is available for preparing Annex XV restriction dossiers (available FTE peryear)

0 1-3 4-6 7-9 >9

*Chemist

*Toxicologist

*Ecotoxicologist

*Epidemiologist

*Economist

*Enforcement

*Legal

*Policy

*Exposure Assessor

*Risk Assessor

*Other (please list):

*125. Do you outsource Annex XV restriction dossiers?

YesNo

*126. Is the Member State satisfied with the levels of access to outsourced expertise?1 = Very low (not appropriate at all); 2 = Low (of some relevance but not of any great significance); 3 = Medium


12345

*

*

*

*

*

*

*

*

*

*

*

*

*

42

0

0

Please provide additional comment if needed:


No Annex XV restriction dossier has been prepared by IE. Any inputs on

Annex XV proposals etc. have only been done via expertise provided to

RAC and SEAC.

*127. Has there been any enterprises consultation/involvement in the preparation of MemberState dossiers?

YesNo



PLEASE NOTE IN ORDER TO ANSWER QUESTIONS 120 TO 123, WE HAD TO TICK YES

TO Q115 EVEN THOUGH WE AS A MS HAVE NOT BEEN INVOLVED IN THE PREPARATION

OF A RESTRICTION DOSSIER

Annex XV SVHC Dossiers

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

YesNo

*132. How many Annex XV SVHC dossiers has the Member State prepared within the reportingperiod?


*133. Among these how many were co-prepared with other Member State/ECHA?Please insert a figure.

*

*

*

*

43

72

1

19

0

*134. How many person-days were dedicated to the development of Annex XV SVHC dossiers?Please insert a figure.

*135. How many person-days were dedicated to the assessment of Annex XV SVHC dossiers?Please insert a figure.

*136. How many times a representative of your Member State has been nominated rapporteurunder the Member States Committee (MSC) within the reporting period?Please insert a figure.

*137. How many dossiers prepared by other Member States has the Member State contributed toor commented upon within the reporting period?Please insert a figure.

*

*

*

*

44

138. What expertise is available for preparing Annex XV SVHC dossiers (in FTEs available peryear)?

0 1-3 4-6 7-9 >9

*Chemist

*Toxicologist

*Ecotoxicologist

*Economist

*Enforcement

*Legal

*Policy

*Exposure Assessor

*Risk Assessor

*Other

*139. Do you outsource the preparation of Annex XV SVHC dossiers?

YesNo



IE has prepared no Annex XV SVHC dossiers to date.

*141. Has there been any enterprises consultation/involvement in the preparation of MemberState dossiers?

YesNo

*

*

*

*

*

*

*

*

*

*

*

*

45



PLEASE NOTE IN ORDER TO ANSWER QUESTIONS 132 TO 141, WE HAD TO TICK YES

TO Q131 EVEN THOUGH WE AS A MS HAVE NOT BEEN INVOLVED IN THE PREPARATION

OF A SVHC DOSSIER

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

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?

Pre 2013 the Authority had limited ad-hoc participation in screening and

RMOA analysis. Since 2013, the Authority now actively participates in

the screening and RMOA activities from the ECHA screening list. To date

we have not found a suitable candidate substance for SVHC

identification.

Pre 2013: 0.1 FTE were available for screening/RMOA activities (approx.

budget of €10,000 to cover salary and other expenses)

Post March 2013: 1 FTE staff for screening/RMOA activities (approx.

budget of €80,000 to cover salaries and other expenses)

Theme 9: Information on REACH enforcement activities

General information

46

*147. Please explain how the enforcement of REACH is organised in your country; pleaseconcentrate on the changes from the last reporting:

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

Environmental Protection Agency Response: The Environmental Protection

Agency of Ireland is responsible for the enforcement of the REACh

Regulation for the purposes of prevention of environmental pollution.

The Agency is responsible for monitoring compliance with requirements

relating to the manufacturing, placing on the market and use of

substances listed in Annex XIV and Annex XVII of the Regulation which

are deemed to pose an environmental risk with the exception of

pesticides/biocides. The Chemicals Team of the Agency's Climate,

Resource and Research Programme, coordinates REACh Regulation activites

within the organisation.

DAFM Response: DAFM is responsible for the enforcement of the REACH

Regulation in respect of Pesticides (i.e Plant Protection Products &

Biocides).

Health and Safety Authority: The REACH Regulation is enforced under the

Chemicals Act of 2008 as amended in 2010 which gives effect to REACH,

CLP and other EU chemicals legislation, and appoints the HSA as the lead

Competent Authority for REACH. This Act nominates the relevant competent

authorities, provides for powers of inspectors, enforcement tools, and

other legal provisions, as well as a number of administrative

provisions.

In the Authority, REACH inspections are carried out by the chemical

(Occupational Hygiene and Seveso) inspectorates in accordance with the

strategy as outlined further on in the questionnaire.

Chemical inspectors carry out both on-site inspections and desk based

investigations and assessments. They are supported by policy staff who

set out the enforcement policy approach for specific areas which include

registration, market surveillance and information in the supply chain.

Surveillance of the market focuses on the use of high risk chemical

substances in chemical products and in doing so determines compliance

with Annex XIV and XVII of REACH.

Enforcement work in relation to registration and evaluation under REACH

is a mixture of pro-active and reactive work.

Since the last MS report was submitted in 2010, the focus for

enforcement in the HSA has moved, following the findings from the IE

Chemicals Usage Survey in Irish Workplace, to high risk chemicals on

the Irish market, i.e. CMRs and sensitisers, targeting those actors with

responsibility for registration, information in the supply chain,

authorisation and restriction obligations.

*

47

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

YesNo

*If No, what are their additional responsibilities?

Environmental Protection Agency Response: The Chemicals Team of the

Climate, Resource and Research Programme, has responsibility for the

monitoring of product essential requirements compliance with respect to

the following internal market legislation:

Directive 2011/65/EU of the European Parliament and of the Council of 8

June 2011 on the restriction of the use of certain hazardous substances

in electrical and electronic equipment (recast);

Directive 2006/66/EC of the European Parliament and of the Council of 6

September 2006 on batteries and accumulators and waste batteries and

accumulators and repealing Directive 91/157/EEC;

Directive 2004/42/CE of the European Parliament and of the Council of 21

April 2004 on the limitation of emission of volatile organic compounds

due to the use of organic solvents in certain paints and varnishes and

vehicle refinishing products and amending Directive 1999/13/EC; and

Regulation (EC) No. 850/2004 of the European Parliament and of the

Council of 29 April 2004 on persistent organic pollutants and amending

Directive 79/117/EEC as amended.

The Chemicals Team also maintains the National PCB Inventory as required

under Council Directive 95/59/EC of 16 September 1996 on the disposal of

polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT).

DAFM response:

The Pesticides Registration and Controls Divisions of the Department of

Agriculture, Food & the Marine are responsible for the implementation of

legislation relating to pesticides, principally the following two

regulations:

- REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 21 October 2009 concerning the placing of plant protection

products on the market and repealing Council Directives 79/117/EEC and

91/414/EEC.

- REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE

*

*

48

COUNCIL of 22 May 2012 concerning the making available on the market and

use of biocidal products.

Health and Safety Authority:

The Health and Safety Authority are also responsible for:

-REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 16 December 2008 on classification, labelling and packaging

of substances and mixtures, amending and repealing Directives 67/548/EEC

and 1999/45/EC, and amending Regulation (EC) No 1907/2006

-REGULATION (EC) No 648/2004 OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 31 March 2004 on detergents

-REGULATION (EU) 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 4 July 2012 concerning the export and import of hazardous chemicals

-DIRECTIVE 2012/18/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 4 July 2012 on the control of major-accident hazards involving

dangerous substances, amending and subsequently repealing Council

Directive 96/82/EC

-United Nations Convention on the Prohibition, Production, Stockpiling

and Use of Chemical Weapons and on their Destruction, signed by the

State at Paris, France on the 13th day of January, 1993

-Directive 98/24/EC - risks related to chemical agents at work of 7

April 1998 on the protection of the health and safety of workers from

the risks related to chemical agents at work

-Directive 2004/37/EC - carcinogens or mutagens at work of 29 April 2004

on the protection of workers from the risks related to exposure to

carcinogens or mutagens at work

-Directive 2009/148/EC of the European Parliament and of the Council of

30 November 2009 on the protection of workers from the risks related to

exposure to asbestos at work

-Directive 2000/54/EC of the European Parliament and of the Council of

18 September 2000 on the protection of workers from risks related to

exposure to biological agents at work

-The Safety, Health and Welfare Act 2005 (No. 10 of 2005) (giving

further effect to COUNCIL DIRECTIVE 89/391/EEC OF 12 JUNE 1989 AND

COUNCIL DIRECTIVE 91/383/EEC OF 25 JUNE 1991)

49

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):1800 character(s) maximum

Environmental Protection Agency Response: Currently the Agency employs

one member of staff part-time (~0.2FTE) for work associated with the

REACh Regulation. The annual budget (2014) for combined REACh Regulation

and Detergents Regulation activities was ~€6,200 (not including labour

costs). The Agency contracts suitably competent contractors for some of

the required inspections activities.

DAFM response: DAFM has 27 staff whose duties include enforcing REACH,

in the context of pesticide legislation enforcement. Both staff

resources and financial resources place limitations on the ability to

carry out enforcement.

Health and Safety Authority: 12.9 FTEs inspectors who work in the area

of chemical enforcement. These same inspectors are also responsible for

awareness raising during their inspection activities, provision of

advice as well as the enforcement of other chemical legislation i.e.

Seveso, Occupational Hygiene (Carcinogens, Chemical Agents, Biological

Agents, Asbestos, Noise at work), DPD-CLP, Detergents and Chemical

weapons.

The level of activity on REACH and CLP enforcement is approximately 3.2

FTE. The annual budget covers only salaries and a small travel and

subsistent allocation for inspections of between 250,000 - 300,000

Euros. Due to the limited resources much of the REACH enforcement

activities are undertaken initially by way of desk top assessments e.g.

the assessment of information in the supply chain requirements or under

Market Surveillance of products suspected to contain Annex XVII

substances.

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

*

50

*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

*

51

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


Agency’s REACh Regulation Implementation Strategy forms part of the

Agency’s overall Chemicals and Producer Responsibility Strategy and

promotes actions required to attain the REACh Regulation’s environmental

objectives within the State. The strategy advocates a risk-based

approach towards surveillance programme development and execution. The

strategy adheres to the relevant provisions of Regulation (EC) No.

765/2008. (Roll out of the Agency's REACh Regulation Implementation

Strategy began early 2015 with the incorporation of certain

recommendations in relation to permitting under the Industrial Emissions

Directive (Directive 2010/75/EU) with further aspects to be implemented

during the year.).

DAFM response: DAFM carries out enforcement of REACH while carrying out

its responsibilities for enforcement of the legislation relating to

plant protection products and biocides. Enforcement is carried out on a

risk based approach.

Health and Safety Authority: The Health and safety Authoritys REACH

enforcement strategy is a subset of the Authority’s overall Strategy and

complies with the Authority’s Vision which is ‘A country where worker

safety, health and welfare and the safe management of chemicals are

central to successful enterprise’. It builds on and implements national

strategic priorities which are:

- Enable enterprises to comply with their legal obligations in a

practical and reasonable manner

- Achieve a high standard of compliance with safety, health and welfare

and chemical laws

-Support the Minister in the development of a well-functioning, robust

and proportionate regulatory framework

- Engage and work with people and organisations nationally and

internationally to achieve our vision.

The annual strategy aims to ensure that the manufacture and use of

chemicals in workplaces and the supply and marketing of chemicals

products ensures a high level of protection of workers, consumers and

the environment as well as to meet the competiveness, market access and

innovation objectives of REACH in particular including the Governments

programme to protect competitiveness and create jobs.

Priorities for enforcement activities are based upon a broad analysis of

the risk of non-compliance. Priorities are afforded to the chemicals of

highest risk (CMRs and sensitisers) and to those actors with the

greatest responsibility in the supply chain.

*

52

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

Environmental Protection Agency Response: The Agency’s REACh Regulation

Implementation Strategy covers surveillance relating to manufacture,

placing on the market and use of substances listed in Annexes XIV and

XVII of the REACh Regulation which are deemed to pose an environmental

risk with the exception of pesticides and biocides. In relation to the

placement on the market of these substances, the strategy employs a

risk-based approach towards targeting of mixtures/articles with

activities ranging from substance/article information (e.g. Material

Safety Data Sheets) checks, to, where deemed appropriate, testing on an

adequate scale. Concerning process surveillance, the Agency’s strategy

focusses on processes associated with highest risks of manufacturing or

using the relevant restricted substances while utilising synergies with

other legislation under the Agency’s remit e.g. certain permitting

aspects relating to the Industrial Emissions Directive, various product

essential requirements compliance monitoring. The Agency’s REACh

Regulation Implementation Strategy encourages cooperation with other

national market surveillance authorities, e.g. authorities in charge of

border controls, in enforcement of the Regulation’s requirements and

liaises with the lead Competent Authority within the State, the Health

and Safety Authority.

DAFM response: Enforcement activities for plant protection and biocides

include inspection of pesticide products at trader and end-user

premises, examination of farm records under Single Farm Payment

cross-compliance inspection, and sampling and chemical analysis of

pesticide products to check compliance with registered specifications.

There is also an extensive program of pesticide residue monitoring in

food products.

Health and safety Authority: The Authority's REACH enforcement strategy

covers registration, outcomes from evaluation decisions, market

surveillance (substances in Annex XIV and Annex XVII) and information in

the supply chain. Enforcement activities covered by inspectors relate to

both site visits and also to desk assessments of chemical products.

Activities covered under Market Surveillance focus on the use of high

risk chemical substances in chemical products and in doing so determines

compliance with Annex XIV and XVII of REACH. Up until 2014, enforcement

in the area of REACH Authorisations has been limited, as the only

authorisation requirement that could be enforced (after 21st August

2014) was the use of MDA and musk xylene.

The Authority’s market surveillance activities aim to identify companies

who may possibly be using substances on Annex XIV, so that inspectors

can check for the presence of these substances. Inspectors also

establish if the companies are aware of the requirement to apply for an

*

53

authorisation or if they intend to continue to use the substance and

whether they are working on a substitution plan. In relation to Annex

XVII substances inspectors check compliance with substances subject to

restriction under entries 28 -30.

In addition, targeted enforcement campaigns in close cooperation with

Customs Authorities are undertaken on relevant RAPEX alerts and other

substances listed in Annex XVII e.g., asbestos in Chinese lanterns,

mercury in measuring devices.

Activities which fall under the scope of information in the supply chain

focus on the quality of safety data sheets (SDS) and general information

to be communicated under REACH with particular focus on high risk

chemicals. This feeds into inspectors checks on chemical agents risk

assessments. Target actors are Irish importers, distributors and

formulators.

Enforcement work in relation to registration and evaluation under REACH

is a mixture of pro-active and reactive work. Pro-active registration

inspections involve work carried out under the REACH-EN-Force (REF) 3

project work. Reactive registration and evaluation inspections

arise as a result of a communication from ECHA regarding an Irish

registrant or from a referral from another MSCA in relation to an Irish

registrant. The activities are a mixture of written communications and

site visits and are shared between policy and enforcement teams and

relate to Statements of non-compliance (SONCs) from ECHA in relation to

dossier evaluation, request from ECHA to follow up on non-compliance

with Article 36 requests, relevant follow up on Quality Observation

Letters (QOBLs) issued by ECHA, and referrals from other Member State

via RIPE in relation to registration.

The Authority's enforcement strategy also includes work from ECHAs Forum

for Exchange of Information on Enforcement including participation on EU

wide Enforcement Projects including REF1, REF2 and REF 3 and pilot

projects as relevant to the programme of work.

*154. Is this enforcement strategy publicly available?

YesNo

*Please provide the link:

Annual programmes of work provide the high level targets for inspection

in any given year -

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Corporate/

Inspection strategy

*

*

54

156. Describe the REACH inspection strategy:

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

Environmental Protection Agency Response: As per response to Question

153, the Agency’s REACh Regulation Implementation Strategy encompasses

surveillance relating to manufacture, placing on the market and use of

substances listed in Annexes XIV and XVII of the REACh Regulation and

which are deemed to pose an environmental risk with the exception of

pesticides and biocides. Regarding the placement on the market of these

substances, a risk-based approach is employed for targeting of

mixtures/articles and activities vary from substance/article

documentation (where available) checks to testing on an adequate scale

(where appropriate). In relation to process compliance surveillance, the

Agency’s strategy promotes enforcement efforts on processes associated

with highest risks of manufacturing or using the relevant controlled

substances. The strategy also endeavours to exploit synergies with other

legislation under the Agency’s remit e.g. certain permitting aspects

relating to the Industrial Emissions Directive (Directive 2010/75/EU),

various product essential requirements monitoring under other internal

market legislation.

DAFM response: DAFM carries out inspections of pesticide products at

trader and end-user premises, examination of farm records under Single

Farm Payment cross-compliance inspection, and sampling and chemical

analysis of pesticide products to check compliance with registered

specifications. There is also an extensive program of pesticide residue

monitoring in food products.

Health and Safety Authority: The Authoritys REACH inspectors carry out

both on-site inspections and desk based investigations and assessments

focusing on high risk chemicals and other non-compliant chemicals noted

within the supply chain.

These inspections/investigations examine:

– Registration and pre-registration of substances under REACH

– Information in the supply chain (safety data sheets and

information within the supply chain and presence of exposure scenarios),

and

- Market surveillance of chemicals under Annex XIV and Annex XVII of

REACH.

A series of questions addressing these topics is provided to the

inspector who then completes during the site visit.

The enforcement of REACH is primarily undertaken by occupational hygiene

and Seveso inspectors. Support is provided by specialist policy

inspectors in the form of training, advice, guidance and development of

specialist question sets for completion during inspections. Policy

inspectors also co-ordinate activities from the Forum relating to REF

55

projects.

All inspections are carried out in accordance with the Authority's

General Enforcement policy.

Each inspection carried out by REACH Inspectors seeks to support duty

holders in so far as resources permit. The Authority also monitors

compliance with REACH by checking the approach used for safe chemical

management. In so doing, the inspector shall ensure his/her enforcement

actions are proportionate to the risks observed.

Generally the emphasis is on the provision of support and information

for compliance, moving on to written advice, where warranted. The choice

of enforcement action is a matter of inspector discretion, guided by the

legal requirements and the Authority’s as well as the chemicals

enforcement programme and guidance.

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

Environmental Protection Agency Response: The Chemicals Team of the

Agency’s Climate, Resource and Research Programme was given

responsibility for the development of the Agency’s REACh Regulation

Implementation Strategy in 2013. The strategy was developed in light of

experiences gained from surveillance activities relating to other

internal market legislation e.g. RoHS Directive (Directive 2011/65/EU),

Paints Directive (Directive 2004/42/CE). Additionally, the strategy was

developed in parallel with the revision of other implementation plans

being developed by the Agency, e.g. certain permitting activities under

Directive 2010/75/EU. Furthermore the Agency’s REACh Regulation

Implementation Strategy has been developed to provide flexibility to

accommodate relevant provisions outlined in the draft new Market

Surveillance Regulation without the need for excessive amendments.

DAFM response: Since 2010, more extensive enforcement of biocide

compliance has been added. Due to resource cuts, the number of

inspections has reduced since 2010. As the number of inspections has

decreased, inspections have been more targeted on a risk-based approach.

Health and Safety Authority: Since 2010, the Authority has had a

reduction in staff which has impacted on the inspection programme. As a

result, the number of on-site inspections has been reduced and the

strategy has moved towards a more targeted proactive and desk based

approach, focusing on the highest risk chemicals and those actors in the

*

56

supply chain with responsibility for ensuring compliance.

As part of the Programme of Work for 2014, work focused on desk based

assessments of chemical products on the Irish market e.g. in 2014, 161

product assessments were completed.

In addition, a number of chemical inspectors were upskilled in the areas

of classification and information in the supply chain (SDSs) to allow

for targeting of those actors at the upper end of the supply chain where

non-compliance is more likely. Desk based assessments of SDSs/labels

are undertaken by the inspectors prior to carrying out arranged detailed

inspections on-site. These detailed inspections are specifically

targeted at those who have obligations to prepare and supply compliant

safety data sheets, labels and packaging under REACH and CLP i.e.

importers, formulators and distributors.

This allows for targeting of those companies importing, manufacturing or

using high risk chemicals (SVHCs). It permits targeting of those

companies with the poorest chemicals management (based on previous

inspection knowledge and from findings of a national Chemical Usage

Survey in Irish Workplaces undertaken in 2012/2013 by the Authority).

Since 2010, with regard to registration/evaluation, the Authority

follows up on enforcement of Statements of non-compliance (SONCs) in

relation to dossier evaluation, non-compliance with Article 36 requests

and relevant follow up on Quality Observation Letters (QOBLs) issued by

ECHA.

The Authority has developed a strategy for market surveillance of

chemicals under REACH (Annex XIV and Annex XVII). Since 2012 a targeted

inspection campaign of specific workplace types which were identified as

likely to use substances on Annex XIV has been undertaken. The

principle aim of the campaign has been to establish what IE industries,

if any, use substances subject to authorisation, and where such

substances are used, to determine whether substitution plans are in

place, along with general awareness raising among the relevant sectors.

In 2012, the first and second priority lists for substances subject to

authorisation were targeted and in 2013 this was updated to include the

third priority list. In 2014, the fourth priority list was included.

Workplaces were identified based on the use categories listed in the

substance dossiers listed on the ECHA website.

With regard to restrictions under Annex XVII, the Authority has run

targeted campaigns on specific restricted substances and participated in

the REF3 project.

The use of RIPE as a tool for inspectors is now used as more widely to

target companies with obligations under REACH.

57

35

*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 Authority's inspection strategy ensures that each inspection carried

out seeks to support duty holders in as much as resources permit. We

monitor compliance with the relevant chemicals legislation by checking

the approach used for safe chemical management. In so doing, the

inspector ensures his/her enforcement actions are proportionate to the

risks observed. Enforcement activity in relation to REACH and CLP also

needs to meet the competiveness, market access and innovation objectives

of these respective pieces of legislation.

The Authority also regularly monitors, assesses and measures its

implementation plan and enforcement outcomes with a view to updating or

amending the overall enforcement strategy if necessary. The plan will

also seek to work in partnership with other enforcement bodies with

which the Authority has memorandum of understanding with.

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

*

58

*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):


Agency is currently investigating the establishment of formal data

exchange agreements with the Customs Services for market surveillance in

relation to a variety of chemicals-related legislation including the

REACh Regulation. Additionally the Agency operates under a Memorandum of

Understanding with the State’s lead Competent Authority for the REACh

Regulation, the Health and Safety Authority.

DAFM response: DAFM operates under a Memorandum of Understanding with

the Health & Safety Authority.

Health and Safety Authority: The Authority has a range of memorandums of

understanding (MoUs) with the following

:

-Department of Agriculture, Food and the Marine (DAFM-PRCD)

-the Revenue Commissioners (Customs Authority for market surveillance

under REACH)

-Environmental Protection Agency (EPA).

The Authority is part of a governmental interdepartmental/agency group

under the Chemicals Act 2008 which is in place to support the

implementation of REACH across the national competent authorities, and

to support the development of common strategic policy approaches.

The Irish Forum member and alternate partake in Forum plenary meetings

and are responsible for coordination of written comments to the Forum

and for the dissemination of information to/from relevant

departments/agencies.

The RIPE focal points in the Authority use the RIPE system to send and

receive referrals from other competent authorities. This ensures

cooperation between MSs on issues of non-compliances.

The Customs Authority cooperates with the Authority on market

surveillance activities.

The Authority also attends the UK Enforcement Liaison Group meetings 2-3

times annually where we are invited to observe and participate in

relevant discussions on REACH related activities.

*

59

*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):

Environmental Protection Agency Response: The Health and Safety

Authority and Environmental Protection Agency meet on an as-needs

basis. Members of the Environmental Protection Agency’s Office of

Environmental Enforcement and the Climate, Resource and Research

Programme attended training for the REF-3 project early 2013, however,

subsequently it was deemed the participation of the Agency personnel was

not required.

DAFM response: DAFM and HSA have met periodically over the reporting

period, for bilateral discussions, and also as part of the Chemicals

Interdepartmental/Agency group.


Nationally, the Authority has held meetings with the other CAs as

relevant and is part of a Chemicals interdepartmental/agency group which

meets approximately once a year. It is chaired by the Department of

Jobs, Enterprise and Innovation, which is the lead government Department

for REACH and CLP.

Within the EU, the Authority has taken part in Forum coordinated REF and

pilot projects and in doing so, has worked in collaboration with other

MSs specifically during phase II of the REF3 project in following up on

of substances registered by only representatives.

The IE Forum member coordinates submission of comments to the Forum and

also sends any relevant information from Forum to the other CAs with

responsibility for REACH.

The RIPE focal point coordinates referrals to and from other MSs.

The Authority participates in the UK Enforcement Liaison Group meetings

2-3 times annually.

*

60

*162. From Forum activities, which ones do you consider most relevant to enhance coordination,cooperation and exchange of information among Member States:

Environmental Protection Agency Response: Unknown.

DAFM response: No comment.

Health and Safety Authority: All REF projects and pilot projects are

beneficial for cooperation between MSs. These projects are also

beneficial for inspectors to exchange information with their

counterparts in other MSs.

The Forum plenary meetings are also a useful platform for sharing

knowledge and increasing awareness on specific issues relating to the

enforcement of REACH.


REF1 on registration duties

REF2 on information in the supply chain duties

REF 3 project specifically phase II of the project where MSs referred on

information on the downstream users of ORs

Pilot project on PAHs in tyres

Pilot project on Authorisation

*

61

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

Environmental Protection Agency Response: None.

DAFM Response: DAFM shares intelligence on illegal trade in pesticides

with other Member States.

Health and Safety Authority: The Authority participated in an Exchange

of Officials in the area of (non-food) consumer product safety in

October 2013 at the Direction Generale de la Concurrence, de la

consummation et de la repression des frauds (DGCCRF) in Paris France.

The Authority submits referrals to other MSs for enforcement follow up.

The Authority also acts on referrals received from other MSs.

The Authority participated in the EuroDeter project coordinated by the

Chemicals Legislation European Enforcement Network (CLEEN) which focused

on compliance of detergent products with the Detergent Regulation. The

information provided in SDSs under REACH was an aspect of the project.

164. Describe any other measures/relevant information:

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

Environmental Protection Agency Response: None.

DAFM Response: None

Health and Safety Authority: None

2010-2014 Reporting on enforcement activities

Number of dutyholders

*

62

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 N/A N/A N/A N/A N/A

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 N/A N/A N/A N/A 378

*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.

Environmental Protection Agency Response: 2013: 20; 2014: 50.

DAFM Response: 2010: 451; 2011: 369; 2012: 344; 2013: 235 & 2014: 156

Health and Safety Authority: 2010: 1483; 2011: 1166; 2012: 804; 2013:

799; 2014: 503

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


2010 2011 2012 2013 2014

Number ofmanufacturers 51 49 42 41 12

*

*

63

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

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


2010 2011 2012 2013 2014Number of onlyrepresentatives

7 5 2 9 8

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

*

*

64

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


2010 2011 2012 2013 2014

Number ofdistributors 564 488 459 372 290

Were these mainly:


*2010

*2011

*2012

*2013

*2014

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


2010 2011 2012 2013 2014

Number ofdownstream users 2697 2431 2004 2031 465

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

*

*

*

65

*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 ofimporters 61 53 50 36 33

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 toalleged 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 ofcontrols N/A 1 2 1 4

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


2010 2011 2012 2013 2014

Number ofcontrols N/A N/A N/A N/A N/A

*

*

*

*

*

*

*

*

66

*175. Monitoring activities?


2010 2011 2012 2013 2014

Number ofcontrols N/A N/A 50 36 50

*176. Results of an inspection?


2010 2011 2012 2013 2014


Number of official controls which addressed…

*177. Registration:




2010 2011 2012 2013 2014

Number ofcontrols 1483 1166 804 799 503

Cases ofnon-compliancefound

7 1 5 7 1

*178. Registration and notification of substances in Articles:


2010 2011 2012 2013 2014



N/A N/A N/A N/A N/A

*

*

*

*

67

*179. Information in the supply chain:


2010 2011 2012 2013 2014



296 371 414 316 161

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


2010 2011 2012 2013 2014

Number of controls N/A N/A N/A N/A N/A


N/A N/A N/A N/A N/A

*181. Restrictions:


2010 2011 2012 2013 2014

Number of controls N/A N/A 174 131 503


N/A N/A 3 1 2

*182. Authorisations:


2010 2011 2012 2013 2014

Number ofcontrols N/A N/A 174 131 42


N/A N/A N/A N/A N/A

*

*

*

*

68

*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



N/A N/A N/A N/A N/A

Number of official controls which resulted in...

*184. No areas of infringement found:


2010 2011 2012 2013 2014

Number ofcontrols N/A N/A N/A 0 0

*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


*

*

*

*

*

69

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:

DAFM response: Legal enforcement notices were issued in all cases of

infringements.

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

Environmental Protection Agency Response: None encountered.

DAFM response: None

Health and Safety Authority: Under restrictions: Ability to find the

appropriate testing facilities for analysis of substances on Annex XVII.

The Authority has also encountered difficulties in the interpretation of

wording on specific entries on Annex XVII.

70

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

Environmental Protection Agency Response: No information to provide.

DAFM response: No information to provide.

Health and Safety Authority: The Authority has an established Inspectors

Enforcement Manual, which contains standard operating procedures which

chemicals inspectors adhere to.

Training on REACH/CLP is held annually. Training prior to Forum projects

is also held as required.

The chemical policy inspectors have prepared a Standard Procedure for

assessing Safety Data Sheets, label, packaging and detergent

requirements for inspector use. The procedure contains a strategic

approach for assessing SDSs, a template for assessments and practical

guidance for inspectors.

A number of Chemicals inspectors have been up skilled in the areas of

classification and information in the supply chain (SDSs) to allow for

targeting of those actors at the upper end of the supply chain where

non-compliance is more likely and where change would have the most

beneficial impact.

Question sets based on MS reporting requirements and REACH/CLP

obligations are prepared annually for inspectors to complete during on

site inspections dealing with REACH. The results of these question sets

are used to steer future strategies, programmes of work and reporting

requirements for REACH and CLP.

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.

Environmental Protection Agency Response: None required.

DAFM response: Any pesticide-related contraventions of REACH may be

enforced using pesticide legislation sanctions. The include legal

enforcement notices, fixed penalty notices, and legal proceedings.

Enforcement notices may direct the offender to return the non-compliant

71

product to source or have it destroyed.

Health and Safety Authority: Sanctions available to enforcement

authorities range from verbal / written advice, to enforcement notices

(contravention and prohibition), to criminal prosecution as provided for

in The Chemicals Act 2008.

Part 4 of the Chemicals Act 2008 outlines the sanctions that can be

used, e.g.

• Appointment of inspectors with extensive powers that include

the power to enter, inspect, examine and search any place to which the

inspector has reasonable grounds for believing that the relevant

chemicals statutory provisions apply; the power to remove and detain

records; and the power to require the removal from the market of a

chemical by the person who has placed that chemical on the market, where

it appears to the inspector that, in relation to that chemical, the

relevant chemicals statutory provisions have been contravened.

• An inspector may direct the person in control of an activity to

submit an improvement plan in situations where the inspector considers

that an activity is occurring or is likely to occur that involves or is

likely to involve a risk to human health and the environment. The

inspector confirms whether he or she is satisfied that the plan is

adequate or may direct that the plan be revised and re-submitted.

• An inspector has the power to issue a contravention notice on

the person who has control of the activity concerned. This arises where

an inspector is of the opinion that the person has contravened any of

the provisions of the relevant chemicals statutory provisions, or has

failed to comply with a direction from the inspector to submit an

improvement plan or a revised improvement plan or has failed to

implement the plan or revised plan. The inspector may direct the

person to remedy the contravention or remove a chemical from the market,

among others.

• An inspector has the power to issue a prohibition notice which

prohibits the carrying on of an activity until the matters that give

rise to a serious risk to health or the environment identified by the

inspector are remedied. Where a prohibition notice is contravened, the

inspector may apply to the High Court for an order prohibiting the

continued contravention of the notice.

• A national authority can apply to the High Court for an order

restricting or prohibiting an activity which involves or is likely to

involve a contravention of the relevant chemicals statutory provisions

and a serious risk to health or to the environment.

Appeals

72

0

0

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

General information

*194. Please explain how competent authorities are organised for the enforcement of CLP in yourcountry; please concentrate on the changes from the last reporting:


Pesticide Registration & Controls Divisions of the Department of

Agriculture, Food & the Marine are responsible for CLP enforcement in

respect of pesticides.

The Health & Safety Authority is responsible for the enforcement of all

substances and mixtures not falling within the scope of the Plant

Protection Products and Biocides legislation.

The CLP Regulation is enforced under the Chemicals Act of 2008 as

amended in 2010 which gives effect to CLP and other EU chemicals

legislation. This Act nominates the relevant competent authorities,

provides for powers of inspectors, enforcement tools, and other legal

provisions, as well as a number of administrative provisions.

CLP inspections are carried out by the chemical (Occupational Hygiene

and Seveso) inspectorates within the Authority in accordance with the

strategy as outlined elsewhere in the questionnaire. Inspectors carry

out both on-site inspections and desk based investigations and

assessments. They are supported by policy staff who set out the

enforcement policy approach for specific areas which include labelling,

packaging and notification to the C&L Inventory. Enforcement is targeted

at chemicals of highest risk (CMRs and sensitisers) and those which are

noted to be non-compliant during inspection.

*

73

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

Two.

Pesticide Registration & Controls Divisions of the Department of

Agriculture, Food & the Marine.


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):1800 character(s) maximum

DAFM response: DAFM has 27 staff whose duties include enforcing CLP, in

the context of pesticide legislation enforcement. Both staff resources

and financial resources place limitations on the ability to carry out

enforcement.

Health and Safety Authority: 12.5 FTEs inspectors who work in the area

of chemical enforcement. These same inspectors are also responsible for

awareness raising during their inspection activities, provision of

advice as well as the enforcement of other chemical legislation i.e.

Seveso, Occupational Hygiene (Carcinogens, Chemical Agents, Biological

Agents, Asbestos, Noise at work), REACH, Detergents and Chemical

weapons.

The level of activity on REACH and CLP enforcement is approximately 3.2

FTE. The annual budget covers only salaries and a small travel and

subsistent allocation for inspections of between 250,000 - 300,000

Euros. Due to the limited resources much of the CLP enforcement

activities are undertaken initially by way of desk top assessments on

classification, labelling and packaging.

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

*

*

74

*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):

DAFM response: Labels of plant protection products and biocidal products

are checked for compliance with CLP as part of the authorisation process

for those products. Product labels are checked for compliance at trader

and end-user premises.

Health and Safety Authority: The Authoritys REACH/CLP enforcement

strategy forms part of the Authority’s overall Strategy and complies

with the Authority’s Vision which is ‘A country where worker safety,

health and welfare and the safe management of chemicals are central to

successful enterprise’. It builds on and implements national strategic

priorities which are:

- Enable enterprises to comply with their legal obligations in a

practical and reasonable manner

- Achieve a high standard of compliance with safety, health and welfare

and chemical laws

-Support the Minister in the development of a well-functioning, robust

and proportionate regulatory framework

- Engage and work with people and organisations nationally and

internationally to achieve our vision.

The annual strategies aim to ensure that the manufacture and use of

chemicals in workplaces and the supply and marketing of chemicals

products ensures a high level of protection of workers, consumers and

the environment as well as to meet the competiveness, market access and

innovation objectives of CLP in particular and Government programme to

protect competitiveness and create jobs.

Priorities for enforcement activities are based upon a broad analysis of

the risk of non-compliance. Priorities are afforded to the chemicals of

highest risk (CMRs and sensitisers) and to those actors with the

greatest responsibility in the supply chain.

*

*

75

*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.

*

76

DAFM response: The current target is for the inspection of 250 trader

premises per annum. While approximately 1250 farmers are inspected under

the Single Farm Payment scheme, only a small number of these receive a

follow-up inspection by Pesticide Registration and Control Divisions

staff, where product labels are inspected.

Health and Safety Authority: An annual target is set by the Authority

for REACH/CLP inspections which are to be undertaken by the chemical

inspectors as part of their inspection programme. The total number of

REACH/CLP inspections undertaken in 2011 was 1166, 2012 was 804, in 2013

was 799 and in 2014 the total was 503. These inspections were carried

out at manufacturers, importers, downstream users and distributors and

covered labelling and notification to the Inventory under CLP.

Following on from the findings of the Chemicals Usage Survey in Irish

Workplaces, chemical inspectors were required to carry out desk based

assessments for Safety Data Sheets (SDSs) and labels focusing on high

priority substances and mixtures i.e. CMRs Cat. 1A and 1B, respiratory

sensitisers and skin sensitisers. Assessments were also required for

those substances/mixtures used at the workplace which the inspector had

concerns about, for example, where the classification was incorrect or

the risk management information was inadequate.

When completing assessments, inspectors follow the Procedure Document

for the Assessment of Safety Data Sheets (SDSs) & Labels for compliance

with the REACH, CPL/CLP and Detergents Regulations which contains full

details on how to check compliance of SDSs and associated labels and

packaging with the rules set out under the REACH, CLP, Dangerous

Preparations and Detergents Regulations.

A template for completing the assessments is included in the procedure.

In addition to the 503 inspections undertaken in 2014, 161product

assessments were completed.

The key reasons provided by inspectors for assessing SDSs/labels in 2014

were:

• Mixture containing a substance or substance on Candidate

List/Annex XIV (authorisation)

• Mixture containing a substance or substance on Annex XVII

(restriction)

• Mixture containing a substance or substance classified as CMR

or respiratory and/or skin sensitiser

• Label/SDS in US format

• Incorrect classification of mixture/substance

• Inconsistent classification on label and SDS

• Assessed as part of detailed inspection programme.

It should be noted that enforcement activities undertaken dealt with

compliance issues both under the Dangerous Preparations Directive

1999/45/EC and the CLP Regulation. This is due to the transitional

period for classification, labelling and packaging of mixtures which is

in place until 1 June 2015.

77

*201. Is this enforcement strategy publicly available?

YesNo

*Please provide the link:

Annual programmes of work provide the high level targets for inspection

in any given year -

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Corporate/

Inspection Strategy

203. Describe the CLP inspection strategy:

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

DAFM response: DAFM carries out inspections of pesticide products at

trader and end-user premises, uinder an annual inspection plan, that

includes Single Farm Payment inspections.

Health and Safety Authority: Chemical inspectors carry out both on-site

inspections and desk based investigations and assessments focusing on

high risk chemicals and those which are found to be non-compliant within

the supply chain.

These inspections/investigations examine:

– classification

– labelling and packaging

of hazardous substances and mixtures under CLP.

A question set addressing these topics is completed.

The enforcement of CLP is primarily undertaken by occupational hygiene

and Seveso chemical inspectors. Support is provided by policy inspectors

with specialist expertise in the form of provision of training and

advice on technical classification issues, development of specialist

question sets for completion during inspections, development of guidance

around classification, labelling and notification to the C&L inventory

and co-ordination of the relevant activities from the Forum.

All inspections are carried out in accordance with the Authority's

General Enforcement policy.

Each inspection carried out by chemical inspectors seeks to support duty

holders in as much as resources permit. Generally the emphasis is on the

provision of support and information for compliance, moving on to

*

*

78

written advice, where warranted. The choice of enforcement action is a

matter of inspector discretion, guided by the legal requirements of the

Authority and the chemicals enforcement programme.

Proactive and reactive interventions and investigations are undertaken

under the CLP Regulation. The focus is on quality of safety data sheets

(SDS) and labels including classification of chemical products.

Proactive inspections: The Authority establishes a list of companies for

targeted and detailed REACH/CLP inspections. Inspections are

specifically targeted at those who have obligations to prepare and

supply compliant safety data sheets, labels and packaging under

REACH/CLP.

Target inspection companies are Irish importers, distributors and

formulators. The focus is on high risk chemicals.

In addition, all trained chemical inspectors carry out REACH/CLP

inspections as part of their annual programme of work. They inspect all

actors within the supply chain and focus on noncompliant products of the

highest risk.

A review of annual question set results has highlighted that a

significant portion of companies inspected are end users of chemicals.

CLP interventions with end users primarily focus on the use of the

information the employer has received, in their workplace risk

assessments and safety, health and welfare procedures.

Reactive inspections are carried out in response to referrals from other

MSs, national agencies and internally from findings on inspections.

79

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

DAFM response: Since 2010, more extensive enforcement of biocide

compliance has been added. Due to resource cuts, the number of

inspections has reduced since 2010. As the number of inspections has

decreased, inspections have been more targeted on a risk-based approach.

Health and Safety Authority: Since 2011, the Authority has had a

reduction in staff which has impacted on the both the REACH and CLP

inspection programmes. As a result, the number of on-site inspections

has been reducedand the strategy has moved towards a more targeted and

specific approach, focusing on the highest risk chemicals and those

actors in the supply chain with responsibility for ensuring compliance.

A number of inspectors were up skilled in the areas of classification,

labelling and packaging under CLP and information in the supply chain

(SDSs) under REACH to allow for targeting of those actors where

non-compliance is more likely and where change would have the most

beneficial impact.

Desk based assessments of SDSs/labels are undertaken by chemical

inspectors prior to carrying out arranged detailed inspections on-site.

These detailed inspections are specifically targeted at those who have

obligations to prepare and supply compliant safety data sheets, labels

and packaging under REACH and CLP i.e. importers, formulators and

distributors. It also allows for targeting of those companies with the

poorest chemicals management (based on previous inspection knowledge and

a national Chemical Usage Survey in Irish Workplaces undertaken by the

Authority).

The use of RIPE as a tool for inspectors to target companies with

obligations under CLP for notification to the C&L Inventory.

It should be noted that enforcement activities undertaken dealt with

compliance issues both under the Dangerous Preparations Directive

1999/45/EC and the CLP Regulation. This is due to the transitional

period for classification, labelling and packaging of mixtures which is

in place until 1 June 2015.

*

80

28

*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



The Authoritys REACH/CLP inspection strategy ensures that each

inspection carried out seeks to support duty holders in as much as

resources permit. We monitor compliance with the relevant chemicals

legislation by checking the approach used for safe chemical management.

In so doing, the inspector ensures his/her enforcement actions are

proportionate to the risks observed. Enforcement activity in relation

to REACH and CLP also needs to meet the competiveness, market access and

innovation objectives of these respective pieces of legislation.

The Authority also regularly monitors, assesses and measures its

implementation plan and enforcement outcomes with a view to updating or

amending the overall enforcement strategy if necessary. The plan will

also seek to work in partnership with other enforcement bodies with

which the Authority has memorandum of understanding with.

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

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

*

81

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

DAFM Response: Periodic meetings of all the regulatory authorities

responsible for chemicals are held. There are also bilateral meetings

with the HSA. At these meetings, CLP related issues may be discussed.


-A memorandum of understanding has been put in place between the HSA and

the Dept. of Agriculture, Food and the Marine in relation to the

operation and enforcement of both the REACH Regulation and the CLP

Regulation under the Chemicals Acts 2008 and 2010.

-The Authority participates in the national governmental

Interdepartmental and Interagency Group under the Chemicals Act 2008.

-In relation to Beaumont Hospital who are appointed as competent

authority for the purposes of Article 45 of CLP only, regular meetings

and correspondence takes place between the National Poisons Information

Centre of that organisation and the Health and Safety Authority on areas

of mutual interest and overlap.

-The IE Forum member and alternate participate in Forum meetings and

coordinate communication to and from the Forum nationally

-The Authority sends referrals to and receives referrals from other MSs

through the RIPE system

-The Authority communicates in an informal way with other MSCA’s/NEAs

via e-mails/telephone calls on matters relating to the labelling and

SDSs of chemicals manufactured/formulated in jurisdictions of other

MSCA’s.

-The Authority attends the UK Enforcement Liaison Group meetings a

number of times annually as an invited observer

-Participation in Commission and ECHA committees and subgroups also

allows the Authority to communicate and engage with other MSCAs/NEAs on

a regular basis in relation to CLP.

*

82

*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):


The Authority have participated in the DAFMs training

(Biocide/Pesticide) on CLP for Stakeholders

The Authority and DAFM prepared and produced a joint information sheet

on labelling and packaging of chemical products.

The National Poisons Information Centre provide information to the

Authority on incidents reported to them.This data has been used to feed

into MS questionnaires where relevant.

In particular the NPIC has provided detailed information on the

incidents relating to detergent liquitabs. They also participated in

Industry meetings with the Authority during the Authority's review of

classification, labelling and packaging of these products.

The Authority is part of a governmental interdepartmental/agency group

under the Chemicals Act which meets approximately once a year. It is

chaired by the Department of Jobs, Enterprise and Innovation, which is

the lead government Department for REACH and CLP.

The IE Forum member coordinates submission of comments to the Forum and

also sends any relevant information from Forum to the other CAs with

responsibility for CLP.

The RIPE focal point coordinates referrals to and from other MSs.

The Authority participates in the UK Enforcement Liaison Group meetings

2-3 times annually.

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 ofcontrols 1535 1148 1034 659

multipaging

*

*

83

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


Number of dutyholders

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 N/A N/A 378

Dutyholders subject to official controls

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


2011 2012 2013 2014

Number ofmanufacturers 49 42 41 12

*

84

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

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


2011 2012 2013 2014

Number ofdistributors 488 459 352 240

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 ofdownstreamusers

1084 758 758 465

*

*

*

*

*

*

*

*

*

*

85

Were these mainly:


*2011

*2012

*2013

*2014

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


2011 2012 2013 2014

Number ofimporters 53 50 36 33

Were these mainly:


*2011

*2012

*2013

*2014

Number of official controls prompted by…

*

*

*

*

*

*

*

*

*

86

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

Number ofcontrols N/A N/A N/A N/A

*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

Number ofcontrols N/A N/A N/A 161


N/A N/A N/A N/A

*

*

*

*

*

87

*221. Hazard communication in the form of labelling:


2011 2012 2013 2014

Number of controls 1166 804 799 664


N/A N/A N/A N/A

*222. Packaging:


2011 2012 2013 2014

Number of controls N/A N/A N/A 664


N/A N/A N/A N/A

*223. Harmonisation of classification and labelling of substances:


2011 2012 2013 2014

Number of controls N/A N/A N/A N/A


N/A N/A N/A N/A

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


2011 2012 2013 2014



6 3 2 13

*

*

*

*

88

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


2011 2012 2013 2014



N/A N/A N/A N/A

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

2011 2012 2013 2014



N/A N/A N/A N/A

*227. Other CLP obligations:


2011 2012 2013 2014



N/A N/A N/A N/A

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


*

*

*

*

*

89

*230. Legal proceedings:


2011 2012 2013 2014


*231. Convictions:


2011 2012 2013 2014


232. Other:

2011 2012 2013 2014


If 'Other', please specify:

DAFM response: Legal enforcement notices were issued in all cases of

infringements.

Health and Safety Authority: It should be noted that enforcement

activities undertaken in the period 2011-2014 dealt with compliance

issues both under the Dangerous Preparations Directive 1999/45/EC and

the CLP Regulation. This is due to the transitional period for

classification, labelling and packaging of mixtures which is in place

until 1 June 2015. Therefore, it is not possible to state the number of

cases of non-compliances noted under CLP specifically as the majority of

mixtures checked were classified, labelled and packaged according to the

DPD.

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):

*

*

90

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.

91

DAFM response: Depending on the individual case, there is a range of

sanctions that may be applied, ranging from enforcement notices, fixed

penalty notices, and legal proceedings. Enforcement notices may direct

the offender to return the non-compliant product to source or have it

destroyed.

Health and Safety Authority: Sanctions available to enforcement

authorities range from verbal / written advice, to enforcement notices

(contravention and prohibition), to criminal prosecution as provided for

in The Chemicals Act 2008.

Part 4 of the Chemicals Act 2008 outlines the sanctions that can be

used, e.g.

• Appointment of inspectors with extensive powers that include

the power to enter, inspect, examine and search any place to which the

inspector has reasonable grounds for believing that the relevant

chemicals statutory provisions apply; the power to remove and detain

records; and the power to require the removal from the market of a

chemical by the person who has placed that chemical on the market, where

it appears to the inspector that, in relation to that chemical, the

relevant chemicals statutory provisions have been contravened.

• An inspector may direct the person in control of an activity to

submit an improvement plan in situations where the inspector considers

that an activity is occurring or is likely to occur that involves or is

likely to involve a risk to human health and the environment. The

inspector confirms whether he or she is satisfied that the plan is

adequate or may direct that the plan be revised and re-submitted.

• An inspector has the power to issue a contravention notice on

the person who has control of the activity concerned. This arises where

an inspector is of the opinion that the person has contravened any of

the provisions of the relevant chemicals statutory provisions, or has

failed to comply with a direction from the inspector to submit an

improvement plan or a revised improvement plan or has failed to

implement the plan or revised plan. The inspector may direct the

person to remedy the contravention or remove a chemical from the market,

among others.

• An inspector has the power to issue a prohibition notice which

prohibits the carrying on of an activity until the matters that give

rise to a serious risk to health or the environment identified by the

inspector are remedied. Where a prohibition notice is contravened, the

inspector may apply to the High Court for an order prohibiting the

continued contravention of the notice.

• A national authority can apply to the High Court for an order

restricting or prohibiting an activity which involves or is likely to

involve a contravention of the relevant chemicals statutory provisions

and a serious risk to health or to the environment.

92

0

0

Appeals

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:

DAFM reponse: None


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:

DAFM reponse: None

Health and Safety Authority: None under CLP

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.

DAFM reponse: None


93

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

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:


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:


DAFM response: None

94

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

YesNo

You may upload one or more documents.

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

Contact [email protected]

*

https://ec.europa.eu/eusurvey/files/457b4be8-39e0-4dc4-87ba-703092ec1ddb