Brussels, 7 January Dear partners,

Transcription

1 ADCA blowing agent: potential inclusion in annex XIV OF REACH Plastics converters Strategy, Voluntary Commitment, update, consortium set-up and next steps Dear partners, Brussels, 7 January 2014 According to our last information dated December 2013, the European Chemicals Agency following the Member States Committee meeting shall in January latest recommend the blowing agent azodicarbonamide (in short ADCA) to be included in annex XIV of REACH (authorization list). ADCA is a blowing agent widely used in the plastics industry (about 3.4 million T of processed foamed plastics products would be concerned). It is now up to the Commission and the REACH Member States Regulatory Committee to decide in the course of 2014 whether to follow or not this scientific recommendation. It would seem that this next step is not making unanimity in Member States. However, if no alternative route is proven to be sustainable, this dossier will probably go until the next step which is authorization. Latest contacts with concerned Authorities confirm to us that our foreseen Voluntary Commitment is an important step towards building this alternative. This information was discussed in an extraordinary EuPC Raw Material Committee held on 18 December 2013 that led us to refine the concept, scope and work programme. I. Which refined scope? 1) Mainly exposure of workers to ADCA powder As a first step the focus of the Voluntary Commitment will be on the exposure of workers during the use only in powder form. All users of ADCA powder in Europe should join the Voluntary Commitment. Exposure of non-powder uses should be investigated as well, but based on a representative sample of measurements per application/processing technique. 2) Investigation in ADCA sensitizing properties Sensitizing properties of ADCA should be investigated in order to : - either reconsider ADCA classification based on new evidence and formulations - and/or determine a safe exposure threshold. This threshold would be the basis in the medium term to determine an EU wide binding Occupational Exposure Limit (OEL) together with The EU Commission DG EMPLOYMENT 3) Communicating this approach to all relevant stakeholders The information on safety should be widely communicated to convince stakeholders that an alternative route to authorization is ensuring and equivalent or higher level of safety for workers in our industry 4) A voluntary reduction of exposure to ADCA Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6

2 It remains a target of the Voluntary Commitment to limit the exposure to ADCA with as a first step all signatories to reach the Occupational Exposure Limit set in the UK (3mg/m³ for short term exposure and 1 mg/m³ per 8 hours). This could be documented via a test measurement or through showing the acquisition of specific equipment. This evidence will be gathered by the consortium manager with the assistance of a certifying third party. II. What are the costs of Authorization should it continue? Based on our experience and first estimate the cost of authorization could range between 1.7 and 2.7 million EUR (out of pocket expenses excluding sweat equity by consortium members). The costs would be divided as follows: 1. Fee for dossier submission to the European Chemicals Agency (not refundable) Depending on the size of the company and the number of uses applied for, the costs would range between 5,330 EUR and 63,960 EUR per company Development of Application for Authorization dossier (common cost for a consortium) a. Management and coordination from set-up until final Commission opinion (3-4 years) : 400,000 EUR b. Development of basic toxicological information : 300, ,000 EUR c. Chemical Safety Report : 200,000 EUR d. Analysis of alternatives 200,000 EUR e. Socio-Economic Assessment : 200,000 EUR f. Substitution Plan : 100,000 EUR (if no adequate control) g. Ongoing support of experts during consultation and opinion formation : 100,000 EUR TOTAL: 1,400,000-1,700,000 EUR One should not forget the major cost not accounted here: the company attention and time spent on the development of the dossier and the increased difficulty to foresee any investment plan. 1 Detailed fees may be found in regulation EU 254/2013. Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6

3 III. ADCA Plastics User Consortium Work programme 2014 (our proposal) The proposed work programme for 2014 is outlined here below. In view of latest information some new common costs appear or have been mutualized. Cost Item Cost in EUR 1. Management & expertise Polymer Comply Europe (12 months) 100,000 EUR 2. Exposure Inventory a. Overview report on test results by Third Party Scientific Institute 50,000 EUR (including test standard) b. Test of exposure to ADCA powder users (tests results according to standard guideline to be provided by users and on their own cost. Estimate cost EUR) 0 EUR c. Testing on a representative sample of companies for each non powder use/application (maximum cost) NEW* 120,000 EUR Any existing exposure measurement on dust or ADCA might however be communicated so as to reduce overall cost 3. Assessing sensitizing effects (toxicology) : contribution to join cost with rest of industry (REACH Centrum, other materials, downstream 70,000 EUR users), classification and safety threshold NEW** 4. Modelling of exposure by FABES. Follow up of Project. Project itself to 10,000 EUR be financed externally. 5. Advocacy certain Member State + EU 50,000 EUR 6. Communication NEW *** 100,000 EUR 7. Meetings & Travel 20,000 EUR Grand Total 520,000 EUR *Since the testing programme primarily focuses on powder use, testing costs that would have had to be borne individually by ADCA non powder users are herewith shared across contributors. **Implementation of the foreseen strategy requires to rule out sensitizing effects or to determine a basis for an Occupational Exposure Limit. This cost is only a share of the overall cost related to toxicological research to be shared by all : manufacturers and users. ***Adequate communication at EU and esp. National level key to the success of a Voluntary Initiative. Please note that most of the costs listed here above contribute to generate data that would be useful in case the Authorization route is chosen in the end and would therefore decrease the cost for Authorization. Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6

4 IV. Financing and setting-up of consortium The cost for joining this consortium is 2500 EUR per company and 1250 EUR for a SME 2. In view of the focused scope and revised work programme, this entry fee should enable to cover the first 6 months of activity. The implementation of the above considered work programme is only possible provided that all companies using ADCA in powder form join the commitment and that more join in order to enable the investigation on non-powder forms. Joining by associations on behalf of their members might be considered but preference is given to companies joining directly. The fee would be defined on a case by case basis depending on the number of companies in each EU Member State, using ADCA powder. WARNING: This Voluntary Commitment will only make sense provided all ADCA powder using companies from each EU Member State contribute. We herewith ask member associations to provide us with a clear picture of ADCA powder (priority) and non-powder users so that we may determine if a representativeness threshold has been reached. This analysis and the result of promotion by member associations shall be evaluated shortly after 31 January 2014 at which date EuPC shall decide to go on with the Voluntary Commitment or not. SHOWING PRO-ACCTIVE BEHAVIOUR, RESPONSIBILITY, A HIGH LEVEL OF PROTECTION OF WORKERS HEALTH WHILST AVOIDING MORE COSTLY REGULATORY OPTIONS IS UP TO YOU! PLEASE RETURN THE APPENDED ADHESION FORM IN ANNEX 3 TO ALEXANDRE DANGIS, EUPC MANAGING DIRECTOR, BY 31 JANUARY 2014 LATEST. We thank you for your cooperation and support. Yours sincerely, Alexandre Dangis EuPC Managing Director EuPC is the leading EU-level Trade Association, based in Brussels, representing European Plastics Converters. Its powerful European Plastics Network exists to support the beneficial use of plastics worldwide, especially providing plastics converting companies with a voice in European legislation. EuPC now totals about 51 European Plastics Converting national and European industry associations, it represents close to 50,000 companies, producing over 45 million tonnes of plastic products every year. Annexes: Annex 1: Voluntary Commitment Timeline Annex 2: Definition of SME according to Commission Recommendation 2003/361 Annex 3: Adhesion form 2 According to the definition of SME laid down in Commission Recommendation 2003/361 (see annex) Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6

5 Annex 1: Voluntary Commitment Timeline 1) By 31 January 2014, a representative number of ADCA Plastics Users join the consortium. 2) All companies using ADCA in Powder form joining the Voluntary Commitment and Consortium commit to measure the exposure to ADCA in their plant according to agreed testing protocols by end April 2014 at the latest and to provide these tests results to the Consortium Manager (data will be treated in strictest confidentiality). 3) By end June 2014, the companies joining the Voluntary Commitment, shall document towards the consortium that they reach the Occupational Exposure Limit set in the UK (3mg/m³ for short term exposure and 1 mg/m³ per 8 hours). 4) By end of June 2014, the Consortium shall also set-up exposure limit targets based on best available techniques and information on ADCA sensitization properties for each compounding/converting process. 5) A Progress report shall be issued in September 2014 to the European Commission 6) By the end of February 2015, the companies shall document their achievement of the Exposure Limit Target to the Consortium either through measurement, modelling or other appropriate technical documentation (e.g. installation of a closed system). 7) A Progress Report shall be issued in April 2015 to the European Commission. 8) By end October 2015, those companies not having met the February deadline shall report compliance with the above target though measurement, modelling or other adequate technical documentation. 9) A Progress Report shall be issued in December 2015 to the European Commission 10) This reporting might have to be repeated one year after (for those not having met the targets yet or having modified their process) in case by that time a binding EU wide Occupational Exposure Limit has not yet been implemented. Annex 2: Definition of SME (Commission recommendation 2003/361) Art. 2: Staff headcount and financial ceilings determining enterprise categories 1. The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. When another company holds than 25 % or more of the capital or voting of a company, the turnover and staff headcount of that upstream company shall be added to the one of the downstream company for the purpose of determining whether a company belongs to the SME category. Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6

6 ANNEX 3 ADCA PLASTICS USERS CONSORTIUM AND VOLUNTARY COMMITMENT ADHESION FORM Company name:. Contact person:. Address: City:. Country: VAT number:. . Phone : Category (Select as appropriate) : Large company SME I herewith confirm to join the ADCA Plastics Users Consortium and to pay the amount of (Large Company)/ 1250 (SME) for the services described in the accompanying letter. I herewith as well confirm I adhere and will implement the above Voluntary Commitment for the limitation of workers exposure to ADCA... Signature of person entitled to represent the company. Date Original to be returned to the attention of Alexandre Dangis, Managing Director European Plastics Converters co EuPC Avenue de Cortenbergh 71,Brussels 1000, Belgium. (Please send scanned copy to nikola.svobodova@eupc.org; tel : +32 (0) ) Avenue de Cortenbergh, 71 - B-1000 Brussels Phone: +32-(0) Fax: +32-(0) /6