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

Transcription

1 Case Id: fd92-4f a91cc805ebd6 Date: 28/05/ :39:24 Member States Reporting under REACH art. 117 / CLP art.46 Fields marked with are mandatory. General Information Please note that depending on what your answers are throughout the questionnaire, hidden questions may show up, so please disregard the numbering in case it does not follow a logic order. A glossary is available in the section 'background document'. 1.Which Member State are you reporting for? Poland 2. Primary contact person's name Ewa Liberska, Justyna Wasikowska 3. Please provide an address for the primary contact person ewa.liberska@chemikalia.gov.pl Theme 1 - Information on the Competent Authority 1

2 4. Please explain how Competent Authorities are organised for the operation of REACH in your country? (Please note that this Section does not include information on enforcement authorities that will be covered under Theme 9 on enforcement) The Polish competent authority for REACH and CLP is Bureau for Chemical Substances. The Bureau for Chemical Substances is an institution of governmental administration responsible for issues related to chemicals in Poland. It is managed and represented by the Inspector for Chemical Substances. The Inspector is supervised by the Minister of Health. In general, the Bureau was formed when Polish legislation was being harmonized with the acquis communautaire, and since then, it has been the Polish competent authority (CA) for chemicals. Bureau for Chemical Substances deals with all issues related to REACH (like: Helpdesk, Evaluation, Risk Assessment, Authorisation, Restriction, Registration etc.). Employees of Polish CA participate in several Committees and ECHA expert groups like: Member States Committee (MSC), Risk Assessment Committee (RAC), Competent Authorities for REACH and CLP (CARACAL) and others. The staff of the Bureau is also involved in the work related to other chemical regulations, Multilateral Environmental Agreements and work in the framework of several international organisations, like: PIC regulation, Detergents regulation, Drug Precursors regulation, Stokholm and Basel Convention, SAICM, POPs regulation, OECD and others. The Bureau is also a competent authority for the inspection and verification of compliance with the principles of Good Laboratory Practice. 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? Bureau for Chemical Subtstances 7. What is the address of the Competent Authority? 30/34 Dowborczykow Str., LODZ, Poland 2

3 8. What is the address of the Competent Authority? 9. What is the telephone number of the Competent Authority? What part of REACH does this part of the Competent Authority deal with? Please choose one or more answers. All Evaluation Risk Assessment Helpdesk Authorisation Restriction Registration Other 11. From what part of Government does this part of the Competent Authority have authority from? Please choose one or more answers. Environment Occupational Health and Safety Public Health Consumer Protection Economy/Industry Other 12. Please specify the number of staff of the Competent Authority working on the implementation of REACH: 19 (in Full Time Equivalent), the same employeess are involved also in other chemical legislation duties, as was shown in question 4 and 10. 3

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 Ecotoxicologist 2 Chemist 3 Exposure Assessor 2 Risk Assessor 2 Risk manager 2 Economist 0 IT 1 Communication 2 Other Is the level of expertise of the Competent Authority adequate to deal with all requirements under REACH? Yes 15. Are the staff of the REACH Competent Authority involved in other chemical legislation? Yes No 4

5 16. What other chemical legislation are the staff of the REACH Competent Authority involved in? Please choose one or more answers. PIC Regulation Food legislation Workers Protection legislation Cosmetics Medical devices Biocides CLP Pesticides POPs Other If Other, please list the different legislations here: Detergents regulation (Competent Authority), Good Laboratory Practice (Competent Authority) Rotterdam, Stokholm and Basel Conventions, Minamata Convention on Mercury, Drug Precursors regulation, new Tobacco Products Directive, Directive on the safety of toys, Regulation on the marketing and use of explosives precursors Globally Harmonized System of Classification and Labelling of Chemicals (GHS), SAICM and other chemicals provisions related to Multilateral Environmental Agreements, European Union Strategy for the Baltic Sea Region (SBSR), Council Decisions and Council Recommendations of OECD 17. Are there any other institutions (agency, institute, regional authorities) that the Competent Authority works with in relation to REACH issues? Yes No If Yes, please list the other institutions that the Competent Authority works with: Ministry of Health, Ministry of the Environment, Ministry of Economy - REACH Committee and Annex XVII of REACH regulation, Ministry of Agriculture and Rural Development, Chief Inspectorate for Environmental Protection, Chief Sanitary Inspectorate, Chief Labour Inspectorate, Customs Service, Office of Competition and Consumer Protection, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Main Inspectorate of Plants Health and Seed Inspection, 5

6 18. Does the Competent Authority outsource any of its work? Yes No If yes, please provide details on who the Competent Authority outsources parts of its work to: Research institutes or other subordinate organizational entities appropriate for cooperation with the Bureau in case of needs. And on what type of expertise is outsourced: Within the scope of health, economy, labour and environment issues for example in the process of the evaluation of substances or in the process of the data collection related with restriction dossier. 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) Does the Competent Authority have appropriate technical resources (understood in terms of expertise, skills and competences of the staff)?

7 21. Does the Competent Authority have appropriate human resources (understood in terms of number of staff)? Space is available below to provide further comments on the resourcing of the Competent Authority. none Theme 2: Information on cooperation and communication with other Member States, the European Chemicals Agency (ECHA) and the Commission 23. How could the communication and collaboration for REACH between Member States be improved? 1,800 character(s) maximum In our opinion, the communication and collaboration for REACH between Member States is not sufficient. There is a lack of communication between the enforcement authorities, especially between those that are responsible for the enforcement and inspections on the local level. It would be very useful to create the list with s and contact details of persons responsible in Members States for particular issues related to REACH and CLP. Moreover, we would see an advantage in more of the joint work (more experienced Member State and Member State with less experience) for example to prepare the restriction dossier or CLH proposal. 7

8 24. How could the collaboration with other agencies in your country be improved? 1,800 character(s) maximum The collaboration with other agencies in Poland is satisfactory. It is regulated by the national act on chemical substances and their mixtures. 25. How could the communication and collaboration with ECHA be improved? 1,800 character(s) maximum The response time to s sent to the functional mailboxes should be shorten. Moreover creating the list with s and contact details of persons responsible in ECHA for particular issues connected with REACH would be very useful. Furthermore from our point of view the ECHA website is not enough user-friendly. There is a lot of information but sometimes it is difficult to find the one that we are particularly interested in. As the competent authority we would also seen an advantage in development of some kind of internal website dedicated only for institutions/agencies with limitted access for public. 26. How could the exchange of information and dialogue between Member States and the Commission be improved? 1,800 character(s) maximum Documents should be sent out earlier because of the need to prepare instructions which must be approved by the Ministry of Health. Nowadays the documents very often are sent by Commission just before the meeting and Member States do not have enough time to read the documents carefully and discuss with experts. Theme 3: Operation of the national helpdesk 8

9 27. Please provide the name of the organisation(s) responsible for operating the Helpdesk(s) for REACH. Bureau for Chemical Substances 28. What is (are) the address(es) of the Helpdesk(s)? 30/34 Dowborczykow Street, Lodz, POLAND 29. What is (are) the web page address(es) of the Helpdesk(s)? What is (are) the address(es) of the Helpdesk(s)? We do not have the address of th Helpdesk. All questions are sent via the webform on our website. 31. What is (are) the telephone number(s) of the Helpdesk(s)? and

10 32. What is the institutional structure of the Helpdesk(s)? Separate independent entity(ies) Part of Competent Authority Part of business association/chamber of commerce Other 33. Please quantify these skills in FTE (Full Time Equivalent). Number of FTE Toxicologist 0 Ecotoxicologist 0 Chemist 2 Exposure Assessor 0 Risk Assessor 0 Risk manager 0 Economist 0 IT 0 Communication 0 Other Is the level of expertise adequate to respond to all enquiries? Yes No 35. For which topics does the national helpdesk feel it necessary to refer the enquirer to the ECHA helpdesk? In particular the issues on REACH IT, IUCLID5 and CHESAR. 10

11 36. What are the services offered by the Helpdesk? Please choose one or more answers. Website Newsletter Advice services Trainings Mediation / conflict resolution Other If 'Other', please specify: meetings with industry (face to face), the "doors open" 37. In which language(s) are these services accessible? Polish and English 38. Is the same Helpdesk used to provide help to Industry on CLP? Yes No 39. Does the Helpdesk receive any non-governmental support? Yes No 11

12 40. Please describe the Helpdesk quality assurance mechanisms: We do not have any quality assurance mechanisms but we have developed an internal procedure on answers the questions. 41. Is ISO9000 norm in place? Yes No 42. How many enquiries does the Helpdesk receive per year? > How are the majority of enquiries received? Please choose one or more answers. Phone Fax Letter Other No information 12

13 44. Do you provide specific advice to SME's? Yes No 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 Medium enterprises Small enterprises Micro enterprises Other N/A N/A N/A N/A 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. 00 % Registration 00 % Evaluation 00 % Authorisation 00 % Restriction 00 % 13

14 Testing (Information requirement/registration) 00 % Data sharing 00 % Enforcement 00 % CSR preparation 00 % CLP Classification 00 % CLP Labelling 00 % CLP Packaging 00 % CLP Classification and labelling inventory 00 % SIEFs 00 % 14

15 REACH-IT 00 % IUCLID5 00 % Downstream user obligations 00 % Only representative obligations 00 % Obligations regarding articles 00 % Safety Data Sheets 00 % SVHC 00 % Other 00 % 15

16 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. Complex Straightforward No 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. 50 % 2) complex 50 % 49. How long, on average, does it take to respond to the following types of questions? 4 hours 1 day 3 days 1 week 2 weeks > 2 weeks No info Straight forward questions Complex questions 50. Are any types of enquiry outsourced? Yes No 52. Does the Helpdesk seek feedback on its performance? Yes No 16

17 53. Does the Helpdesk review its performance and consider ways to improve its effectiveness? Yes No 54. How could the cooperation between Helpdesks under Helpnet be improved? 1,800 character(s) maximum In our opinion the cooperation is appropriate. 55. How could the cooperation between Helpdesk outside Helpnet be improved? 1,800 character(s) maximum In our opinion the cooperation between Helpdesks is proceeding very well and there is no need to improve it. 56. How frequently do you use HelpEx? Daily Weekly Monthly Less frequently Theme 4: Awareness raising activities 57. Has the Member State carried out any specific awareness raising activities? Yes No 17

18 58. What types of activities have been carried out? Please choose one or more answers. Television spots Articles in Newspapers Radio spots Speaking events Information seminar Telephone surveys Leaflets and newsletters Articles in industry magazines Website / Social Media Other If other, please list the activities that have been carried out: - The most effective tool we use to increase awareness of the obligations under the REACH and CLP regulations is the Bureau website: Website provides all information concerning the tasks of the Bureau. The site includes the latest legislation, Polish and European documents, as well as the latest news on chemicals. In 2010, the Bureau prepared a new website, which enabled easier and more user-friendly access to its content. A new website has been prepared in accordance with the latest trends in the construction of the existing governmental services and websites, provides better functionality, transparency, and has been adapted to the needs of disabled people by adding a version with high contrast and by allowing the possibility of increasing the font. - A very effective tool for dissemination of information is also a subscription mechanism, integrated with the Bureau website. Under this option, anyone who provide us with address shall be notified of new chemicals related legislation and events. At the end of 2014, there were 2384 subscription users - Another important part of our awareness raising activities is the website of national helpdesk for REACH ( available also in English. Information published on the website helps entrepreneurs in fulfilling their obligations related to the REACH system, and upon logging to the website, they have the possibility to ask questions to the national helpdesk Staff - In December 2010, the Bureau embarked on a new website dedicated entirely to the CLP Regulation ( This website contains a number of detailed information and guidelines to facilitate interested stakeholders to fulfill the requirements of the CLP. Visitors can find news and information about their responsibilities as well as have the opportunity to use a mechanism to ask questions to experts from the 18

19 National Helpdesk. The website is fully integrated with the website - In March 2010, the Bureau sent leaflets for producers, importers, downstream users of chemicals, as well as for consumers using household chemicals. Information leaflet contains summary of the most important information about the Regulation (EC) No 1272/ pointing the dates on which the new principles of classification, labeling and packaging apply, provide samples of new pictograms, and information about institutions who can provide detailed information on the CLP. This leaflet has been distributed among entrepreneurs in cooperation with Polish enforcement authorities - Bureau for Chemicals Substances organized in May 2010 one day conference on REACH and CLP, dedicated to small and medium-sized enterprises ("SMEs"). The event has been organized in Lodz, Poland. The main goal of the conference was to remind entrepreneurs about their obligation under REACH and CLP regulations. The basic theme of the conference, attended by 200 participants, covered general obligation to register substances on their own or in mixtures and obligation for entrepreneurs to classify, label and package substances and mixtures placed on the market. One part of this conference was devoted to raising understanding of the IT tools. The conference was led by employees of Polish Competent Authority, representative of ECHA, REACH consultants at the Ministry of Economy and industry representatives. It is worth underlining that ECHA has responded positively to our request and kindly provided an expert to this conference, who offered his presentation in Polish language - From 17th to 19th November 2010, the Bureau for Chemical Substances and Preparation participated in the third edition of the Fair of Plastics and Rubber Processing Industries RubPlast EXPO in Sosnowiec, Poland. Bureau has been invited to cooperate on the so called "Knowledge Zone". Entrepreneurs have had the opportunity to talk directly with the staff of the Bureau, to discussed industry-specific issues relating to chemicals and uncertainties regarding the interpretation of the REACH regulations and CLP. One of the key points of the fair was a conference on EU chemical legislation, conducted under the auspices of Bureau During the fair, three types of leaflets (prepared by Bureau) were distributed: Leaflet: Safe use of chemicals " Leaflet informing about the Bureau tasks Information leaflet "Notification of the classification and labeling as one of the responsibilities of producers and importers. - In 2010, Bureau organized twelve (two-day) workshops for State Sanitary Inspectorate Staff. Workshops was organized in connection with the entry into force of the CLP Regulation, which taking in to force the principles of Globally Harmonized System of Classification, Labelling and Packaging of Chemicals (GHS). The 199 representatives of Sanitary Inspectorate participate in those workshops - In 2011, Bureau distributed, via and post, reminders of the REACH obligations Letter which was send to remind of the necessity of full registration and to encourage to take actions on Substance 19

20 Information Exchange Forum (SIEF). Letters and s have been sent to those companies who have pre-registered their substance in REACH-IT or was registered on the Bureau for Chemicals Substances website - In November 2011, the Polish Ministry of Economy in cooperation with Bureau for Chemical Substances, organized an International Conference to mark (celebrate) the fifth anniversary of REACH regulation. REACH Conference was addressed to entrepreneurs, downstream users, exporters and importers of chemicals, public administration, including enforcement authorities and scientific communities - In the reporting period, Representative of the Bureau participated in the in three sessions of International Conferences of Household Chemicals organized under the patronage of Bureau for Chemicals Substances. The main goal of the conferences was to disseminate information concerning the obligations imposed on manufacturers and importers of household chemicals under the REACH and CLP regulations. The lecture delivered by Bureau staff aimed to address concerns of entrepreneurs from household chemicals sector in relation to the obligations imposed on them by the REACH and CLP regulations. The conference materials was complemented by information leaflets prepared by the Bureau -In May 2014 the Polish Ministry of Economy in cooperation with Bureau for Chemical Substances, organized the conference regarding CLP regulation. The conference aimed to help the entrepreneurs to fulfilling their obligations concerning the new classification and labeling of chemical mixtures which must be fulfilled before 1 June In 2014 Bureau conducted Information campaign "Safe school and home". The campaign was meant for children to draw their attention to the hazards associated with the use of chemicals, and indicate the safe way of handling chemicals. Thanks to the campaign, the children had the opportunity to familiarize themselves with new CLP pictograms, which appears on frequently used household chemicals. The directors and teachers from the elementary schools in Lódź Voivodship was acquainted with the campaign objective and asked to distribute the bookmarks and fridge magnets with CLP hazard symbols and to stress the importance of reading the safety instruction and safe use of chemicals during classes - In 2014 Bureau join as a partner to the multilingual digital education campaign Keep Caps from Kids Campaign was design to educate consumers on safe use and storage of liquid laundry detergent capsules - To increase awareness and meet the expectations of entrepreneurs, Bureau regularly organizing, at its facilities events called Information Centre for REACH and CLP Open Doors. During the event doors national helpdesk staff, in cooperation with other Bureau for Chemicals Substances employees, providing face-to-face advice and guidance and consult on the obligations imposed on the business by REACH and CLP. - In the reporting period, Bureau published the six bulletins: Chemistry, Health, Environment. The purpose of the Bulletin is to provide a broad and free access to knowledge and practical information about the toxicology and ecotoxicology, as well as: analyzing and supporting the search of solutions to problems arising from the implementation in Poland and the EU REACH and CLP regulations 20

21 requirements and related legislation presenting the views on various aspects of the implementation of the requirements of international conventions and agreements, presenting the analysis procedures and methods of testing properties of the chemicals needed to, in accordance with the law, the risk and hazard assessment The purpose of the bulletin is to promote the concept and enhance the effectiveness of regulatory toxicology as a tool to achieve improved public health, environmental protection and support innovation in the economy. For practitioners in the field of chemical safety bulletin is an information tool that provides the supply of knowledge about solutions being implemented to protect human health and the environment at Community level, Member States, industries and specific uses of chemicals. Moreover, raise the issue of requirements of REACH and CLP Regulation caused an increase of awareness in this area. Bulletin is published in Polish, is available in electronic version and can be downloaded from the Bureau website. 59. Who is the target audience for your awareness raising activities? Please choose one or more answers. Consumers directly Consumers indirectly through multipliers (media, associations etc) SME in downstream sectors All companies in downstream sectors SMEs in chemicals sector All companies in chemicals sector Other If 'Other', please specify: Kids and their parents please refer to point 58. Enforcement Authorities - please refer to point 58. General Public - please refer to point Please describe how the information was adapted for the specific target audience: The presented in point 58 awareness raising activities was adapted for the specific target audience by suit the level of detail to the needs of recipient. Ex. During campaign "Safe school and home", CLP hazards symbols printed on the education material was describe in the way easy to understand by young kids and their parents. For more detail please refer to point

22 61. How effective was each type of activity? 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) If you have not ticked an activity in question 59, please state N/A 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? Yes No 64. Do you have a REACH webpage/website? Yes No 22

23 65. Do you have a single webpage for REACH or multiple pages? Single webpage Multiple webpages 66. How frequently is the REACH webpage visited (per month)? 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? Yes No 68. What has been the overall public funding on research and development of alternative testing in your Member States each year? Euros 0-10,000 Euros 10, ,000 Euros 100,001-1,000,000 More than Euros 1, 000, 000 No information 69. Please mention other relevant activities carried out on information on the Promotion of the Development, Evaluation and Use of Alternative Test Methods: none 23

24 Theme 6: Information on participation in REACH Commission and ECHA expert groups / committees (Forum, REACH Committee, MSC, RAC, SEAC, CARACAL, RCN, Helpnet) 70. How effective is the work of the FORUM Committee? 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)

25 71. Please specify if needed: 1,800 character(s) maximum The Forum tasks are: Spread good practice and highlight problems at EU level - elaboration and distribution between inspectors of Manual of Conclusions (MoC) - translation of MoC and other ECHA Guidances into national languages of MS - organisation of training for enforcement trainers - discussion of practical enforcement issues Propose, coordinate and evaluate harmonised enforcement projects and joint inspections - realisation of REACH-EN-FORE project, REACH-EN-FORCE-2, REACH-EN-FORCE-3 and few pilot projects - prioritisation of REACH-EN-FORCE harmonized and pilot projects on the basis of proposals submitted by Forum Members, EC and Industry - interlinks between ECHA and NEAs related to the follow-up of ECHA s decisions by inspectors were further intensified, particularly with regard to the follow up of SoNC resulting from dossier evaluation decisions. The cooperation between ECHA and NEAs, facilitated by a network of focal points in all MS is used and functional Coordinate exchange of inspectors (study visits) Identify enforcement strategies, as well as best practice in enforcement - amendment of enforcement strategy - elaboration of Multi- Annual Work Programme for next years - preparation of compendium of analytical methods Develop working methods and tools of use to local inspectors - continuous development of RIPE - input for development of SDS checklists Develop an electronic information exchange procedure Liaise with industry, taking particular account of the specific needs of SMEs, and other stakeholders - organisation of Open sessions and workshops Examine proposals for restrictions with a view to advising on enforceability (Art.77(4)) - preparation of Forum Advice within Forum Working Group on Restrictions 72. How could the effectiveness be improved? 1,800 character(s) maximum Further simplification of procedures and reports 25

26 73. How effective is the work of the REACH Committee? Please specify if needed: 1,800 character(s) maximum The persons who take part in the REACH Committee work may not be considered as impartial because some of them are also the representatives of RAC or SEAC or other forums, which means that they are involved in the earlier stages of legislative process. 75. How could the effectiveness be improved? 1,800 character(s) maximum From our point of view the socio-economical factors should have bigger influence on the final REACH Committee decisions. 76. How effective is the work of the Member States Committee (MSC)? Please specify if needed: 1,800 character(s) maximum Work of the Committee is effective, however it seems that more issues could be solved by written procedure or discussed during teleconferences. The most visible disadvantage in the MSC processes is the fact that the comments received during public consultation in most cases are not taken into account. 26

27 78. How could the effectiveness be improved? 1,800 character(s) maximum We hope to see more activities outside the plenary (written procedures, teleconferences) as well as more careful consideration of the views expressed by third parties (competent authorities, industry, non-governmental organizations) in the draft decisions and opinions prepared by ECHA. 79. How effective is the work of the Risk Assessment Committee (RAC)? Please specify if needed: 1,800 character(s) maximum How could the effectiveness be improved? 1,800 character(s) maximum How effective is the work of the Socio-Economic Committee (SEAC)?

28 83. Please specify if needed: 1,800 character(s) maximum The lack of Polish representative in SEAC does not allow us for the proper assessment during the reporting period. 84. How could the effectiveness be improved? 1,800 character(s) maximum As above 85. How effective is the work of the CARACAL (Competent Authorities for Reach and CLP)? Please specify if needed: 1,800 character(s) maximum One of the main problem of the effectives of the CARACAL is lack of documents in advance of the meeting. A lot of documents are sent just before the meeting. The Competent Authority do not have enough time to prepare for the meeting. Sometimes the documents have to be consulted with other ministry or with enforcement authorities. From our point of view effective are mainly these meetings that result in endorsment of the document. Long period of elaboration of the common possitions by all interested parties as: MS, ECHA and CE makes the proces not too effective especially for the industry that expects quick and clear solution. Moreover, taking into account the high costs of the accommodation in Brussels, we suggest to organize CARACAL meeting in the country of the current Presidency. 28

29 87. How could the effectiveness be improved? 1,800 character(s) maximum By creating specific CARACAL sub-groups that will focus on solving problematic issues. The cooperation beetween the members of these sub-grups should be coordinated by the European Commission and could be carry out by teleconferences or Webex. 88. How effective is the work of the Risk Communication Network (RCN)? Please specify if needed: 1,800 character(s) maximum The Risk Communication Network (RCN) was a voluntary network of nominated staff members from the REACH MSCAs, or their delegates, with responsibilities for communication to the general public on risks from chemical substances covered by REACH and their use, including the specific tasks covered by Article 123 of Regulation (EC) No 1907/2006 ( the REACH Regulation ). The work of RCN was very effective and appreciated by PL MSCA until Since 2012 Risk Communication Network has been placed on hold. There was no further activities, nor exchange of experience conducted by the RCN after How could the effectiveness be improved? 1,800 character(s) maximum In line with its objective of providing the platform to elaborate practical steps on risk communication, the Risk Communication Network should convenes its members for occasional plenary meetings as well as workshops, not only as a platform for the exchange of experience, but also for topical training events and other hands-on activities. 29

30 91. How effective is the work of the HelpNet Committee? Please specify if needed: 1,800 character(s) maximum We are not familiar with the name: "HelpNet Committee". We assessed the HelpNet Steering Group in the work of which we are involved. 93. How could the effectiveness be improved? 1,800 character(s) maximum In our opinion the activity of the HelpNet is appropriate. Theme 7: Information on Dossier Evaluation and Substance Evaluation activities Dossier evaluation 94. Has the Member State been involved in Dossier evaluation within the reporting period? Yes No Substance evaluation 102. Has the Member State been involved in substance evaluation within the reporting period? Yes No 30

31 103. How many substances evaluated resulted in a draft decision within the reporting period? Please insert a figure On average, how many person-days have been employed in the evaluation of each substance within the reporting period? Please insert a figure On average, how many person-days have been employed in the decision-making of each substance within the reporting period? Please insert a figure Indicate if possible what tasks have been most demanding in terms of resources: Analyzing of the available data Preparing SEV Report Commenting phase before MSC meeting for draft decision 31

32 107. Please indicate the number of each type of staff that are involved in substance evaluation: >10 Toxicologist Ecotoxicologist Chemist Risk Assessor Social-Economic Analyst Exposure Assessor Other (please list): If Other, please list: lawyer - legal advisor 108. Do you outsource substance evaluations to external contractors? Yes No 109. Have you collaborated with other Member States in any of these evaluations within the reporting period? Yes No 32

33 110. 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 harmonised C&L, annex XV dossier for SVHC ID or restriction, other non-reach regulatory action) within the reporting period? Yes No If yes, please specify the action: National restriction on methanol Annex XV for restriction in case of methanol 111. What are the financial resources dedicated by your Member State to substance evaluation? The significant part of the Bureau budget is dedicated for the process of substance evaluation because the financial resources provided by ECHA are not sufficient Do the fees delivered for evaluation equate the financial resources involved in substance evaluation? Yes No 113. Do you foresee an increase of resources dedicated to substance evaluation in the coming years? Yes No 114. Have you encountered any problems while carrying out the substance evaluation? Yes No Theme 8: Annex XV Dossiers (restriction and identification of SVHC) and other points related to the identification of SVHC Annex XV Restriction Dossiers 33

34 115. Has the Member State been involved in the preparation of Annex XV Restriction Dossiers within the reporting period? Yes No 116. How many Annex XV restriction dossiers has the Member State prepared within the reporting period? Please insert a figure Among these how many were co-prepared with other Member States/ECHA? Please insert a figure How many person-days were dedicated to the development of Annex XV restriction dossiers? Please insert a figure How many person-days were dedicated to the assessment of Annex XV restriction dossiers? Please insert a figure How many times a representative of your Member State has been nominated rapporteur under the Risk Assessment Committee (RAC) within the reporting period? Please insert a figure How many times a representative of your Member State has been nominated rapporteur under the Socio-Economic Committee (SEAC) within the reporting period? Please insert a figure. 0 34

35 122. How many times a representative of your Member State has been nominated co-rapporteur under the Risk Assessment Committee (RAC) within the reporting period? Please insert a figure How many times a representative of your Member State has been nominated co-rapporteur under the Socio-Economic Committee (SEAC) within the reporting period? Please insert a figure. 4 35

36 124. What expertise is available for preparing Annex XV restriction dossiers (available FTE per year) >9 Chemist Toxicologist Ecotoxicologist Epidemiologist Economist Enforcement Legal Policy Exposure Assessor Risk Assessor Other (please list): 125. Do you outsource Annex XV restriction dossiers? Yes No 36

37 126. 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 (reasonably appropriate); 4 = High (highly appropriate); 5 = Very high (completely appropriate) Please provide additional comment if needed: 1,800 character(s) maximum none 127. Has there been any enterprises consultation/involvement in the preparation of Member State dossiers? Yes No Please provide additional comment if needed: 1,800 character(s) maximum not relevant because we did not carry out the consultation with the industry Annex XV SVHC Dossiers 131. Has the Member State been involved in the preparation of Annex XV SVHC Dossiers? Yes No 37

38 132. How many Annex XV SVHC dossiers has the Member State prepared within the reporting period? Please insert a figure Among these how many were co-prepared with other Member State/ECHA? Please insert a figure How many person-days were dedicated to the development of Annex XV SVHC dossiers? Please insert a figure How many person-days were dedicated to the assessment of Annex XV SVHC dossiers? Please insert a figure How many times a representative of your Member State has been nominated rapporteur under the Member States Committee (MSC) within the reporting period? Please insert a figure How many dossiers prepared by other Member States has the Member State contributed to or commented upon within the reporting period? Please insert a figure. 9 38

39 138. What expertise is available for preparing Annex XV SVHC dossiers (in FTEs available per year)? >9 Chemist Toxicologist Ecotoxicologist Economist Enforcement Legal Policy Exposure Assessor Risk Assessor Other 139. Do you outsource the preparation of Annex XV SVHC dossiers? Yes No Please provide additional comment if needed: 1,800 character(s) maximum not relevant 39

40 141. Has there been any enterprises consultation/involvement in the preparation of Member State dossiers? Yes No 142. If yes, what was the level of involvement of enterprises in the preparation of Member State dossiers? 1 = Very low (not involved at all); 2 = Low (involved but not of any great significance); 3 = Medium (reasonably involved); 4 = High (highly involved); 5 = Very high (fully involved) Please provide additional comment if needed: 1,800 character(s) maximum Polish companies provided information only on the volumes and uses of 3 substances. The low number of responses recieved may be treated as the lack of understanding of the procedures. The enterprises are not obliged to deliver such information Among these enterprises, were there SMEs also consulted/involved in the preparation of Member State dossiers? Yes No 144. If yes, what was the level of involvement of SMEs in the preparation of Member State dossiers? 1 = Very low (not involved at all); 2 = Low (involved but not of any great significance); 3 = Medium (reasonably involved); 4 = High (highly involved); 5 = Very high (fully involved)

41 Please provide additional comment if needed: 1,800 character(s) maximum Please look at the additinal comment under the question no 142 Other points related to the identification of SVHC 145. Do you consider that there is enough coordination between ECHA and Member States during the implementation of the SVHC Roadmap? Yes No 146. What were the financial and human resources dedicated to SVHCs identification (both screening and preparation of an Annex XV dossier) before and after the agreement on the SVHCs Roadmap in March 2013? Unchanged 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. Enforcing authorities responsible for compliance with REACH provisions have been specified in the national legislation (The Act of 25 February 2011 on the chemical substances and their mixtures (Dz. U. [Journal of Laws] of 2011 No. 63, item 322)). Pursuant to Article 29 of this Act, the following authorities enforce compliance with the provisions of the Act and provisions of regulations, as laid down in Article 1(1), within their respective competence: the State Sanitary Inspection, the State Sanitary Inspection of the Ministry of the Internal Affairs and the Military Sanitary Inspection, the Inspection of Environmental Protection, the State Labour Inspection, the 41

42 Trade Inspection, the State Fire Service and Customs Authorities. The State Sanitary Inspection is the leading enforcing authority. Control-related activities are carried out by inspectors at regional level (poviat - district, Voivodship province and border sanitary-epidemiological stations), which are coordinated and supervised by the Chief Sanitary Inspector. Article 29 of this Act provides that provisions of the Act and provisions of the regulations REACH and CLP are enforced by various enforcement authorities within the scope of their respective competence, as well as: 1) Inspection of Environmental Protection in terms of threats to the environment, which concern: a) Adequacy of the safety data sheets in terms of: Procedures implemented in case of an unintended release of a substance or a mixture to the environment, Storage of a substance or a mixture, Waste-related procedures, Ecological information, b) Downstream users compliance with the duties specified in Article 37(5) and (6) of Regulation No. 1907/2006 concerning the application of risk control measures within the scope necessary to ensure that any risk to the environment is adequately controlled, c) Compliance with the conditions specified in the authorisation granted in accordance with provisions of Title VII of Regulation No. 1907/2006 to use chemical substances listed in Annex XIV to Regulation No. 1907/2006, d) Downstream users compliance with the provisions concerning the restrictions of manufacturing, placing on the market and application of chemical substances and their mixtures in accordance with Article 26 of the Act, or provisions laid down in Article 67 of Regulation No. 1907/ within the scope of its respective competence, e) Compliance with the provisions of Regulation No. 1907/2006 concerning substances recovered in particulars or as an ingredient in a mixture; 2) State Labour Inspection in terms of enforcement and control of compliance with the provisions of the Act - within the scope of its respective competence; 3) Trade Inspection in terms of compliance with: a) Duty of performing the required registration of a substance and the duty of submitting the required safety data sheet to the recipient of the substance or mixture, b) Provisions laid down in Article 26 of the Act, or the provisions laid down in Article 67 of Regulation No. 1907/2006 within its respective competence, c) Provisions of Article 11 of Regulation No. 648/2004 in terms of labelling detergents in wholesale and retail, d) Article 20 and Article 22 of the Act and the provisions of Title III and IV of Regulation No. 1272/2008 in relation to wholesale and retail; 42

43 4) State Fire Service in terms of appropriate marking of the sites of storage of substances and mixtures laid down in Article 4(1), subparagraphs 1-5 of the Act, and in Part 2 of Annex I to Regulation No. 1272/2008; 5) Customs Authorities - in terms of compliance with the provisions concerning: a) Export and import of dangerous chemicals laid down in Regulation No. 689/2008, b) A substance, mixture or article, whose import is banned or is subject to import-related restrictions, in accordance with the provisions issued based on Article 26, c) Import of a substance, mixture or article, specified in Title VII of Regulation No. 1907/2006, d) Import of a substance, mixture or article, listed in Annex XVII to Regulation No. 1907/2006; customs authorities notify the competent state sanitary inspector of cases of import of substances, mixtures or articles which raise their doubts in terms of the importers compliance with the conditions laid down in this Annex. State Labour Inspection Pursuant to the provisions of the Act of 13 April 2007 concerning the State Labour Inspection (Dz.U consolidated text, as amended), the SLI (State Labour Inspection) performs enforcement of the employers compliance with the duties laid down in Article 35 and Article 37(5) and (6), as well as in Article 9(4) of Regulation (EC) No 1907/2006 (REACH). Moreover, the State Labour Inspection also performs enforcement of compliance with the provisions of Regulation of the European Parliament and of the Council (EC) No. 1272/2008 (CLP). The above-listed enforcement authorities cooperate under the Cooperation Forum, whose activities are regulated by virtue of an Agreement dated on 23 March 2010 on establishing the Forum of Cooperation in the field of enforcement of chemicals, in which the parties particularly undertake, within their respective competence. Moreover, due to the intensive progress of international work (EU, UNO, and OECD) in the field of chemicals as well as due to the need to involve national institutions in this work to protect the interest of enterprises operating in chemical industry, a National Forum of Information Exchange on Chemicals has been established in Poland. Members of the Forum meet every quarter at the Ministry of Economy, and these meetings are strictly informational participants of the work carried out internationally provide representatives of the national institutions with up-to-date information on the state of this work and planned changes to the legislation on chemicals. 43

44 148. Are the national enforcement authority(ies) in charge of REACH, only dealing with REACH? Yes No If No, what are their additional responsibilities? The State Sanitary Inspection Apart from addressing REACH aspects, the State Sanitary Inspection is designated to implement tasks in the field of public health, particularly by enforcing conditions of hygiene of the environment, occupational hygiene in enterprises, radiation-related hygiene, hygiene of teaching and educational processes, hygiene of leisure and recreation, health-related conditions of food, nutrition and objects of use, hygiene and sanitary conditions to be met by medical personnel, equipment and premises where medical services are rendered to protect human health against unfavourable impact of environmental hazards and burdens, prevent occurrence of diseases, including infectious and occupational diseases. The scope of tasks and duties resulting from the Act on the State Sanitary Inspection of 14 March 1985? (Dz. U. of 2011 No. 212, item 1263, as amended) for occupational hygiene personnel who are also responsible for REACH enforcement covers: -health conditions in the work environment, particularly preventing occurrence of occupational diseases and other diseases related to work conditions, -compliance by entities which place on the market precursors of category 2 and 3 with the duties which result from the Act of 29 July 2005 on counteracting drug addictions (Dz. U. No. 179, item 1485, as amended), Regulation (EC) of the European Parliament and of the Council No. 273/2004 of 11 February 2004 on drug precursors and Regulation (EC) of the Council No. 111/2005 of 22 December 2004 laying down the rules for the monitoring of trade between the Community and third countries in drug precursors, -Requirements laid down in the provisions on the content of certain substances in cigarette smoke, -Control of compliance with provisions concerning placing on the market of biocidal products and active substances, and their use in professional activities, -Control of compliance with provisions of the Act of 22 June 2001 on microorganisms and genetically modified organisms (Dz. U. of 2007 No. 36, item 233, of 2009 No. 18, item 97 and of 2015 item 277), in terms of the conditions referring to occupational hygiene at genetic engineering facilities, -Control of compliance with conditions and restrictions to place on the market and use of surfactants and detergents containing surfactants, as 44