member states reporting under reach art. 117 / clp art · mailing lists should be regularly...

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Case Id: 7fa898b8-aa6c-409a-af69-7d56e392fa9bDate: 26/05/2015 12:48:04

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

Fields marked with * are mandatory.

General Information

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

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

*1.Which Member State are you reporting for?

Finland

*2. Primary contact person's name

Annette Ekman and Marilla Lahtinen (Finnish Safety and Chemicals Agency)

*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)

Finnish Safety and Chemicals Agency is appointed Competent Authority for

REACH in Finland.

*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.

1

One / First Competent Authority Responsible for REACH

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

Finnish Safety and Chemicals Agency (Tukes)

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

P.O. Box 66 (Opastinsilta 12 B), FI-00521 Helsinki, Finland

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

[email protected]

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

+358 29 5052 000 (switchboard)

*

*

*

*

*

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:

14 persons + 1 IT

*

*

*

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 4.5

Ecotoxicologist 4.5Chemist 2

Exposure AssessorRisk Assessor

Risk manager

Economist

IT 0.2

Communication

Other 0.8

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

The level of expertise is considered adequate. The resources are however

too scarce.

*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:

Regulation (EC) No 648/2004 on Detergents

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

Authority works with in relation to REACH issues?

YesNo

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

Ministry of Social Affairs and Health / Department for Occupational

Safety and Health

Ministry of the Environment

Finnish Institute of Occupational Health

National Institute for Health and Welfare

Finnish Environment Institute

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

YesNo

*

*

*

*

*

6

*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 of

expertise, skills and competences of the staff)?

12345

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

number of staff)?

12345

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

Resources allocated to the implementation of REACH are in general

limited, but especially resources to socioeconomic assessment and human

health assessment should be strengthened.

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

*

*

*

7

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

improved?

1,800 character(s) maximum

Official communication is comprehensive. There is however a need for

informal communication and contacts between experts in the MSCAs. MSs

should have information on how the responsibilities have been divided in

the different MSs in order to take the appropriate contacts and reach

the concerned part. Possibilities for establishing and maintaining a

list of contact points for instance in circabc could be considered.

Access to a certain Interest Group should not be a prerequisite to

access the list.

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


The collaboration between potential agencies is generally functioning

well. Contacts have been established, meetings are arranged for the

sharing of information and projects are carried out in collaboration.

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


Information on who to contact in ECHA with different issues is sometimes

hard to get. Contact information seems to be easier to find after the

renewal of the web pages but a further description of division of

responsibility between different people would be helpful.

The different working groups established by ECHA are much appreciated.

Face to face meetings of experts in there WGs contribute to the common

understanding of matters under consideration and discussion. Appointment

of SEv dossier managers at ECHA for Corap substances is also much

appreciated.

Newsgroups (such as the RAC newsgroup) could be considered to enhance

discussions between ECHA, ECHA Committee members and MSCA experts. Webex

and MSC meetings are not always sufficient.

The arrangement of seminars and workshops on topics relevant for a

harmonized implementation and common understanding are welcomed and the

continuation supported.

*

*

*

8

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

Commission be improved?


CARACAL offers a good platform for the dialogue.

Mailing lists should be regularly updated. Information on who keeps the

lists up to date should be available in order for MSCAs to be able to

send corrections to the Commission. New messages should always be

addressed to the current mailing list, not sent as “reply” to an old

message.

Theme 3: Operation of the national helpdesk

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

REACH.

Finnish Safety and Chemicals Agency (Tukes)

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

P.O. Box 66 (Opastinsilta 12 B)

FI-00521 Helsinki

Finland

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

www.kemikaalineuvonta.fi

*

*

*

*

9

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

The Helpdesk does not have a specific email address. Customers send

their requests by a query form that is available on the web page of the

Helpdesk and they get the answers to their email addresses. The query

form can be found at:

http://www.kemikaalineuvonta.fi/fi/kysymyslomake/

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

+358 4400 393 033

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

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

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

Number of FTE

Toxicologist 0

Ecotoxicologist 0.5

Chemist 0.5

Exposure Assessor 0

Risk Assessor 0

Risk manager 0

Economist 0

IT 0

Communication 0

Other 1.2

*

*

*

*

10

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

YesNo

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

helpdesk?

Topics on IT-issues, e.g. REACH-IT, IUCLID5 and Chesar.

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


WebsiteNewsletterAdvice servicesTrainingsMediation / conflict resolutionOther

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

We provide our services mainly in Finnish, partly in Swedish and

English.

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

YesNo

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

YesNo

*

*

*

*

*

*

11

*40. Please describe the Helpdesk quality assurance mechanisms:

The helpdesk has prepared SOPs (standard operating procedures) for the

working procedures. All Helpdesk answers are saved to the IT-system. The

target replying time is 7 days and it is used as an indicator of

effectiveness of the Helpdesk. The helpdesk is supported by REACH

experts from the CA.

*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

*

*

*

*

*

*

*

*

12

%0

%11

%2

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

YesNo

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

The information provided to customers of the Helpdesk are not customised

especially for SMEs. However it should be noticed that most companies

are SMEs in Finland. All companies seeking advice are served equally.

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

them represent)

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

%

Large enterprises N/A

Medium enterprises N/A

Small enterprises N/A

Micro enterprises N/A

Other N/A

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

enquiries during the reporting period:Pre-registration

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

*Registration

*Evaluation

*

*

*

*

*

13

%1

%14

%6

%1

%1

%0

%0

%5

%4

*Authorisation

*Restriction

*Testing (Information requirement/registration)

*Data sharing

*Enforcement

*CSR preparation

*CLP Classification

*CLP Labelling

*CLP Packaging

*

*

*

*

*

*

*

*

*

14

%0

%14

%0

%0

%0

%0

%0

%0

%4

*CLP Classification and labelling inventory

*SIEFs

*REACH-IT

*IUCLID5

*Downstream user obligations

*Only representative obligations

*Obligations regarding articles

*Safety Data Sheets

*SVHC

*

*

*

*

*

*

*

*

*

15

%5

%95

%37

*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

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

*

*

*

*

*

*

*

16

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

YesNo

*If yes please specify by whom and what the result was:

Tukes has carried out a general customer survey to all its customers.

The survey was answered by 626 customers. Comments were received among

others on the functioning of the helpdesk. In addition the Helpdesk has

conducted an open survey to its customers. These both surveys indicated

that the helpdesk is functioning well and the customers content with the

work. The feedback was mainly positive. Some customers however requested

more tailored made answers to their questions instead of general replies

based on references to the legal text.

The Helpdesk arranges meetings with representatives of stakeholders

twice a year. The aim is to get feedback on and ideas to the work of the

Helpdesk and to discuss information and communication activities as well

as difficult topics.

*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?

Improved webpages, publication of FAQs, fact sheets and info letters as

well as lecturing at seminars have contributed to an improved

effectiveness of the Helpdesk.

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


The same kind of IT-tool/platform as Fabasoft Cloud is needed for

discussion and sharing information.

*

*

*

*

17

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


The cooperation under HelpNet is well-functioning and there is no need

for other kind of cooperation in addition to that.

*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

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


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

*

*

*

18

*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:

The information provided has concerned for instance restrictions,

substances in articles, registration, authorization and REACH

obligations in general. Topic and tailor made programmes for seminars

have bee planned in cooperation with the organizer of the event. The

communication and awareness raising activities follow the proceedings,

deadlines and transitional periods related to the implementation of

REACH/CLP, amendments to REACH/CLP and ECHA’s news.

*

19

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

*

*

*

*

*

*

*

*

*

*

*

*

20

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

Single webpageMultiple webpages

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

1-100101-500501-50005001+No information

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

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

validation of alternative test methods by participating in relevant committees?

YesNo

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

your Member States each year?

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

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

The Finnis Centre for Alternative Methods, FICAM, is the centre of

expertise for alternative methods to animal experimentation in Finland

(www.ficam.fi).

FICAM develops and validates human-cell-based tissue/organ models,

shares information on alternative methods, educates experts, and acts as

the Finnish reference laboratory for EURL-ECVAM (European Union

Reference Laboratory for Alternatives to Animal Testing). The basis of

FICAM’s activity lays on EU directive 2010/63.

*

*

21

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

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



12345

71. Please specify if needed:


Issues that are handled in Forum are important and usually practical.

Sometimes the discussion might go too deep into details and take too

much time from the meeting.

72. How could the effectiveness be improved?


Too complicated details could be tackled via written procedure.

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

12345

*

*

22





Timely distribution of documents should be a priority. The meetings

should be scheduled taking into consideration the new challenges caused

by the progress of the implementation of REACH, e.g. the increasing

number of authorisations.

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

12345



Streamlining of all the processes is ongoing with good results.



Constantly monitoring the processes in order to find streamlining

possibilities.

*

23

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

12345







possibilities.

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

12345




*

*

24




possibilities.

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

12345



CARACAL is a valuable forum for the Commission, ECHA and Member States

to change views on and discuss matters relating to the implementation

and functioning of REACH. The work of Caracal has been and is constantly

improved.



Timely distribution of documents is needed and should be a priority.

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

12345

*

*

25



No actual activity so far.



Joint EU-wide campaigns for awareness raising could be considered.

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

12345



It is a good practice to organize workshops under different regulations

instead of discussing every topic in steering group meetings.



*

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170

14

103

Theme 7: Information on Dossier Evaluation and SubstanceEvaluation activities

Dossier evaluation

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

YesNo

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

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

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

presence in the Member State Committee)?

Please insert a figure.

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

YesNo

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

served its purpose?

YesNo

*

*

*

*

*

*

27

25

123

2

100. How could it be improved?


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

period?

YesNo

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.

*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.

*

*

*

*

*

28

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

Challenges in estimating the future workload due to the cumulative

nature of SEv (assessement of the new data based on the information

requirements in earlier evaluations, completion of SEv reports and

Conclusion documents).

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):

*If Other, please list:

Lawyer

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

YesNo

*

*

*

*

*

*

*

*

*

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

reporting period?

YesNo

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

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

YesNo

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

No additional resources dedicated to substance evaluation. The resources

are included in those allocated to the REACH competent authority.

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

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

Annex XV Restriction Dossiers

*

*

30

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

within the reporting period?

YesNo

Annex XV SVHC Dossiers

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

YesNo

Other points related to the identification of SVHC

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

YesNo

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?

No additional financial resources were allocated to the SVHC Roadmap

work. The available resources were to some extent reallocated to issue

relevant for the SVHC Roadmap work.

Theme 9: Information on REACH enforcement activities

General information

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

concentrate on the changes from the last reporting:

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

*

*

*

31

The duties and roles of different authorities are defined in the

Chemicals Act (599/2013);

http://www.finlex.fi/en/laki/kaannokset/2013/20130599 that entered into

force 1st October 2013. Market surveillance issues were then transferred

to the Finnish Safety and Chemicals Agency (Tukes) from Occupational

health and safety authorities and from municipal chemical enforcement

authorities.

The task of the Finnish Safety and Chemicals Agency is to supervise

compliance REACH Regulation, unless otherwise provided in the Act.

The Occupational health and safety authority supervises compliance with

REACH in all work where the employer is bound by the Occupational Safety

and Health Act. The duties relate to the worker protection issues in a

workplace.

The Centre for Economic Development, Transport and the Environment and

the municipal environmental protection authority supervise compliance

with the following provisions of the REACH regulation: Articles 14 and

37 concerning the conditions and risk reduction measures for the use of

substances, Title VII on the use of substances requiring authorisation

and Article 67 on restrictions on the use of substances. The enforcement

is performed in the supervision of activities that pose a threat of

environmental pollution in accordance with the Environmental Protection

Act to the extent that the supervision concerns the operator's

obligation to prevent harmful environmental effects in the use and

storing of chemicals.

The Finnish Medicines Agency ensures that good laboratory practice is

observed in research activities in accordance with the provisions laid

down in the chemicals legislation of the European Union.

The Finnish Customs supervises compliance with REACH concerning the

import, export and transit of chemicals and articles containing

chemicals. It is the particular duty of Customs to ensure that:

1) the registrations and notifications referred to in Title II of the

REACH Regulation have been performed when importing substances and

mixtures and articles containing them;

2) the authorisation referred to in Title VII of the REACH Regulation

has been granted when importing substances subject to authorisation and

mixtures containing them;

3) the restrictions referred to in Article 67 of the REACH Regulation

are observed when importing substances and mixtures and articles

containing them. When a shipment arrives in Finland from a member state

of the European Union, Customs supervises compliance with restrictions

under Annex XVII of REACH.

The Finnish Defence Forces supervises compliance with REACH in the

military activities of the Finnish Defence Forces or in the training

organised for this purpose, as well as in targets kept confidential for

the purposes of national.

32

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

YesNo

*If No, what are their additional responsibilities?

The Finnish Safety and Chemicals Agency (Tukes) supervises and promotes

the technical safety and conformity, together with the consumer and

chemicals safety in Finland. Branches of Tukes are articles of precious

metals; chemicals, biocides, plant protection products; industrial

handling of chemicals and gases; gold panning, exploration and mining;

consumer safety; refrigeration branch; legal metrology; pressure

equipment; rescue service equipment; construction products; explosives

and fireworks; electricity and lifts; inspection bodies.

Occupational health and safety authority enforces worker protection

legislation i.e. issues related to the safety and health of the worker

in the workplace.

Centre for Economic Development, Transport and the Environment and

municipal environmental protection authority enforce environmental

protection issues.

The Finnish Medicines Agency enforces the safety and authorization of

medicines.

Customs and the Defence forces work in their own areas of competence.

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

N/A

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

*

*

*

33

*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

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

The national REACH enforcement policy was developed when the new

Chemicals Act (599/2013) was prepared. It is based on the principle that

all nominated authorities have their own special duties that do not

overlap with each other. If there would be gray areas where no one seems

to be responsible for the enforcement then Tukes has an overall power to

enforce all REACH issues. Inspections to the sites dealing with

chemicals are carried out by regional and local authorities that are

already enforcing other (chemicals related) legislation in those sites.

The idea is that (excluding special enforcement campaigns) the

authorities carry out enforcement of REACH when carrying out enforcement

of other legislation in accordance with the Occupational Safety Act and

Environmental Protection Act. Tukes has the responsibility for all

market surveillance issues since October 2013.

Based on the principles laid down the above enforcement authorities have

prepared their individual enforcement strategies.

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

Division of tasks are laid down in the Chemicals Act.

The enforcement strategy of OSH inspections covers the actual use of the

chemical at the workplace (the operational conditions & RMMs):

Registration-supply chain-end use, SDS, exposure scenarios and risk

assessments, authorisation and restrictions.

The strategy prepared by Tukes for market surveillance covers risk based

prioritisation of chemicals by hazard and exposure. It also entails

description of the means that are used by the authority. It is renewed

with a yearly plan for enforcement projects to be carried out.

*154. Is this enforcement strategy publicly available?

YesNo

Inspection strategy

*

*

*

*

34

156. Describe the REACH inspection strategy:

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

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

As the new Chemicals Act defined the roles and duties of enforcement

authorities in a different way also the inspection strategies have had

to be changed accordingly. The duties have more focused to 1) market

surveillance (responsibility of Tukes) and 2) surveillance of the

conditions of use (occupational and environmental authorities).

All authorities are now struggling with scarce resources and enforcement

is done in a risk based way. Efforts of authorities have to be

concentrated to those issues where the risk caused by the non-compliance

is seen highest.

OSH inspections: SLIC WG CHEMEX Guidance 2013; translated not yet

approved in Finnish and in Swedish. National Guidance approved 2014;

implementation from 2015 onwards.

*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 organization of enforcement has been changed in order to achieve

effective, efficient, transparent and systematic enforcement in Finland.

The Customs is actively involved and has also its own competence in

enforcing REACH as defined in the Chemicals Act.

*

*

35

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

*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):

The Finnish Safety and Chemicals Agency has decided to coordinate a

network of different chemicals legislation enforcement authorities in

Finland. The network has started in the beginning of 2015 but also

before there has been a lot of coordination and exchange of views

between the authorities.

OSH: SLIC WG CHEMEX

SLIC WP Chemicals

Nordic network

national chemical network

national OSH chemical network

national OSH campaigns on chemical safety

*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):

During the reporting period there has been regular meetings arranged by

the Ministry of Social Affairs and Health and the Ministry of the

Environment in relation to chemicals enforcement. Information is

provided also via mailing lists.

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

cooperation and exchange of information among Member States:

The common enforcement projects and discussion on the practical issues

including work of working groups.

*

*

*

36


Finland has participated to all REF projects and we are now envolved in

the pilot project on authorization. These projects provide valuable

knowledge and information on practical issues regarding enforcement.

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

remit of the Forum:

There has been for example exchange of information relating to companies

or non-compliant products that are found in Sweden or Norway and the

responsible downstream user is located in Finland.

164. Describe any other measures/relevant information:

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

2010-2014 Reporting on enforcement activities

Number of dutyholders

*

37

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 N/A

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

20 000. This covers all REACH specific inspections and also all

inspections related to chemical issues in occupational health and safety

enforcement. In addition the Centre for Economic Development, Transport

and the Environment and the municipal environmental protection authority

supervise the operator's obligation to prevent harmful environmental

effects in the use and storing of chemicals.

The fields below are however filled only when there has been a REACH

specific inspection.

*

38

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


2010 2011 2012 2013 2014

Number of manufacturers 5 10 10 10 9

*

39

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

*

*

*

*

*

40

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


2010 2011 2012 2013 2014Number of only representatives 0 0 0 2 5

*

41

Were these mainly:


*2010

*2011

*2012

*2013

*2014

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


2010 2011 2012 2013 2014

Number ofdistributors 76 45 45 41 101

Were these mainly:


*2010

*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

*

*

42

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


2010 2011 2012 2013 2014

Number ofdownstream users 194 214 266 123 437

Were these mainly:


*2010

*2011

*2012

*2013

*2014

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

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

2010 2011 2012 2013 2014

Number of importers 148 145 152 154 154

*

*

*

*

*

*

*

43

Were these mainly:


*2010

*2011

*2012

*2013

*2014

Number of official controls prompted by…

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

alleged contraventions of the REACH Regulation?

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

out by enforcing activities.


2010 2011 2012 2013 2014

Number of controls 8 8 N/A 21 75

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


2010 2011 2012 2013 2014

Number of controls 12 9 27 13 19

*175. Monitoring activities?


2010 2011 2012 2013 2014


*

*

*

*

*

*

*

*

44

*176. Results of an inspection?


2010 2011 2012 2013 2014

Number of controls 20 N/A N/A N/A 41

Number of official controls which addressed…

*177. Registration:




2010 2011 2012 2013 2014

Number of controls N/A 15 N/A 2 6

Cases ofnon-compliancefound

N/A 8 N/A 0 0

*178. Registration and notification of substances in Articles:


2010 2011 2012 2013 2014



0 0 0 0 0

*179. Information in the supply chain:


2010 2011 2012 2013 2014



64 72 82 18 145

*

*

*

*

45

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


2010 2011 2012 2013 2014



0 0 0 0 1

*181. Restrictions:


2010 2011 2012 2013 2014



6 1 1 6 30

*182. Authorisations:


2010 2011 2012 2013 2014



0 0 0 0 0

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

2010 2011 2012 2013 2014



85 75 67 67 60

Number of official controls which resulted in...

*

*

*

*

46

*184. No areas of infringement found:


2010 2011 2012 2013 2014


*185. Verbal or written advice:


2010 2011 2012 2013 2014


*186. Legal proceedings:


2010 2011 2012 2013 2014


*187. Convictions:


2010 2011 2012 2013 2014


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

2010 2011 2012 2013 2014


*

*

*

*

47

If 'Other', please specify:

In Finland the enforcing authority is not able to use fines or other

sanctions ("legal proceedings") but they have to be taken through a

court decision by the police and prosecuter. This route is not much

used. The enforcing authorities may instead use legally binding

administrative actions that are reported here in "Other" box 188. If the

operator does not comply with the provisions of REACH/CLP, the

supervisory authority in question may ban the operator from continuing

operations or repeating procedures in violation of the provisions or it

may order the operator to otherwise fulfil the obligations laid down by

law.

The Finnish Safety and Chemicals Agency may issue orders concerning a

chemical or article containing a chemical with respect to banning them

from being placed on the market or from being made available on the

market, the return procedure or notification of the hazard inflicted, or

it may order that the chemical be made harmless by taking appropriate

measures. The authority may also issue a conditional fine that has to be

paid by the dutyholder if he does not comply with the decision of the

authority. In addition the authority may inform the operator that the

measure that has been left unperformed will be carried out at the cost

of the neglecting party, or issue a notice concerning the suspension of

activities.

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

The legislation and different roles of national authorities are

considered difficult and confusing. More education and guidance (in

Finnish or Swedish) is needed for the inspectors. Implementation of

REACH enforcement into the environmental protection enforcement is

difficult because of lack of resources and complexity of the REACH

legislation. Annual targets, guidelines and working tools are missing

for REACH in environmental protection enforcement.

Information would be needed on the types of sites typically using

certain chemicals that need to be taken into account in the enforcement.

The format used for the Member States art 117 report is too complicated

and questions can be interpreted differently.

48

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

Requiring information (like lists of chemicals, their composition and

classification/labelling used on site) from the dutyholder already

before the inspection makes the inspection easier. Also the dutyholder

should familiarize with the issues before inspection.

Cooperation and joint inspections with other enforcing authorities.

Inviting companies' REACH experts/ product safety management to join the

environmental protection enforcement when issues related to REACH

articles 14, 37 and 67 are handled.

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.

See last reporting period and specification of "Other" above.

Appeals

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

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

Theme 10: CLP enforcement activities

General information

49

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

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


The Chemicals Act (599/2013);

http://www.finlex.fi/en/laki/kaannokset/2013/20130599 defines the roles

of authorities in CLP enforcement. The Finnish Safety and Chemicals

Authority (Tukes) has been the only enforcement authority named for CLP

since 1.10.2013.

During the reporting period also the Occupational Health and Safety

authority and the municipal chemicals enforcement authority had duties

relating to CLP enforcement.

In addition The Finnish Medicines Agency ensures that good laboratory

practice is observed in research activities in accordance with the

chemicals legislation of the European Union.

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

From 1.10.2013 only one, the Finnish Safety and Chemicals Agency

(Tukes).

Before 1.10.2013, please see previous answer.

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

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

*

*

*

50

*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):

Enforcement is prioritized based on risk and chemicals are divided into

groups depending on the hazards and exposure. The most prioritized

chemicals are for example corrosive detergents, acutely toxic chemicals

like methanol based wind screen fluids, lamp oils causing aspiration

hazard etc.

2010-2013 OSH: The 2011 national campaign on chemical safety was focused

on businesses using respiratory and skin sensitising chemicals. 2011

REACH-EN-FORCE-2 formulators. The 2012 national campaign on chemical

safety was focused on metal industries using stainless steel and acid

proof steel.

*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.

There has been enforcement projects on for example detergents and wind

screen fluids. Many of the chemicals have been classified and labelled

according to the DPD and not CLP during the reporting period. A lot of

the workload in enforcement has been allocated to advisory and

promotional activities also.

2010-2013 OSH: 2011 respiratory and skin sensitising chemicals. 2012

stainless steel, acid proof steel and hazardous chemicals at the

workplace

*201. Is this enforcement strategy publicly available?

YesNo

Inspection Strategy

*

*

*

*

51

203. Describe the CLP inspection strategy:

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

Tukes gets a lot if notifications from competitors, customers and also

other enforcement authorities like occupational health and safety

authorities on chemicals that are wrongly labeled. We prioritize these

notifications based on the risk caused by the non-compliance.

The enforcement actions of our own initiative are strongly based on

risk.

Communication on enforcement is found to be a valuable tool because

communicating publicly about the enforcement the message finds also

those companies that are not picked up for enforcement.

There are a lot of small errors in the labeling of chemicals in the

Finnish market and especially the fi and sv language is a common problem

when chemicals are imported. We try to focus our own resources to the

most hazardous ones and for the others let the companies know that they

have the responsibility to correct the labels.

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

As the national legislation on the duties of authorities has changed

also the strategy has been revised. There are no more municipal

authorities or occupational health and safety authorities to enforce

CLP. Tukes tries to shift the responsibility for correcting the errors

to the companies themselves and not to act like a consultant even though

it would be appreciated by the companies.

*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


Risk based enforcement and focus to the most essential requirements that

are needed to inform about the risks for health and the environment.

*

*

52

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

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

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

During the reporting period the responsibility for enforcing CLP was on

3 authorities (Tukes, Occupational health and safety authorities,

municipal authorities). Training and information were provided by Tukes

to the other authorities. From autumn 2013 only Tukes is responsible for

enforcing CLP so there is no need for coordination so much anymore.

Tukes is also the Competent Authority for CLP.

Other authorities are encouraged to inform Tukes when they find false

labels in chemicals during their own enforcement actions.

*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):

Joint trainings have been arranged on CLP to other authorities.

2011-2014 Reporting on enforcement activities

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

2011 2012 2013 2014

Number of controls 278 298 26 55

*

*

*

53

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


OSH: 2011 national campaign on chemical safety on businesses using

respiratory and skin sensitising chemicals. 2011 REACH-EN-FORCE-2

formulators. 2012 national campaign on chemical safety on metal

industries using stainless steel and acid proof steel.

A Nordic Project on CLP and a CLEEN Eurodeter project for detergents

were carried out by municipals and Tukes

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 N/A

Dutyholders subject to official controls

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


2011 2012 2013 2014

Number ofmanufacturers 3 3 2 4

*

54

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 49 34 12 27

Were these mainly:


*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

55

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


2011 2012 2013 2014

Number ofdownstream users 82 151 2 20

Were these mainly:


*2011

*2012

*2013

*2014

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


2011 2012 2013 2014

Number of importers 14 14 10 1

Were these mainly:


*2011

*2012

*2013

*2014

*

*

*

*

*

*

*

*

*

*

56

Number of official controls prompted by…

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

alleged contraventions of the CLP Regulation?




2011 2012 2013 2014

Number of controls N/A N/A N/A 5

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


2011 2012 2013 2014

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

*218. Monitoring activities?


2011 2012 2013 2014

Number of controls 207 311 N/A 33

*219. Results of an inspection?


2011 2012 2013 2014


Number of official controls which addressed…

*

*

*

*

57

*220. Hazard classification:


2011 2012 2013 2014



30 122 6 24

*221. Hazard communication in the form of labelling:


2011 2012 2013 2014



170 155 25 51

*222. Packaging:


2011 2012 2013 2014



9 10 4 2

*223. Harmonisation of classification and labelling of substances:


2011 2012 2013 2014


Cases ofnon-compliance found 42 21 N/A 1

*

*

*

*

58

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


2011 2012 2013 2014

Number of controls 190 242 N/A N/A


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

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

information:


2011 2012 2013 2014

Number of controls 190 242 N/A N/A

Cases ofnon-compliance found 53 103 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

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

Cases ofnon-compliance found N/A N/A N/A N/A

*227. Other CLP obligations:


2011 2012 2013 2014



N/A N/A N/A 0

Number of official contols which resulted in...

*

*

*

*

59

*228. No areas of infringement found:


2011 2012 2013 2014


*229. Verbal or written advice:


2011 2012 2013 2014


*230. Legal proceedings:


2011 2012 2013 2014


*231. Convictions:


2011 2012 2013 2014


232. Other:

2011 2012 2013 2014


*

*

*

*

60

If 'Other', please specify:

In Finland the enforcing authority is not able to use fines or other

sanctions but they have to be taken through a court decision by the

police and prosecuter. This route is not much used. Instead the

authorities may use legally binding administrative actions that are

reported here in "Other" box 232. If the operator does not comply with

the provisions of REACH/CLP, the supervisory authority in question may

ban the operator from continuing operations or repeating procedures in

violation of the provisions or it may order the operator to otherwise

fulfil the obligations laid down by law.

The Finnish Safety and Chemicals Agency may issue orders concerning a

chemical or article containing a chemical with respect to banning them

from being placed on the market or from being made available on the

market, the return procedure or notification of the hazard inflicted, or

it may order that the chemical be made harmless by taking appropriate

measures. The authority may also issue a conditional fine that has to be

paid by the dutyholder if he does not comply with the decision of the

auhtority. In addition the authority may inform the operator that the

measure that has been left unperformed will be carried out at the cost

of the neglecting party, or issue a notice concerning the suspension of

activities.

Sanctions

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

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

different to that provided by virtue of CLP Article 47.

No major changes since last reporting period. See also above explanation

to box "Other".

Appeals

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

61

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:

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:

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.

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

62

240. Please provide a brief explanation of your response:


EU evaluation cannot be done without data from Member States. In order

to get meaningful data a very limited set (e.g. 5 - 10) of harmonised

indicators is needed.

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:


The reporting of the implementation of REACH would benefit from a more

concise reporting format with less but focused questions accompanied

with good guidelines for filling in the format. The results of a more

focused report would also aid the implementation itself.

*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

*

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

63

Contact [email protected]