Chemicals in products - legislation

Transcription

1 Chemicals in products - legislation Karin Rumar, Senior Technical Officer Enforcement karin.rumar@kemi.se

2 EU Chemicals legislation General legislation Products legislation CLP Detergents Cosmetics VOC RoHS/ REACH WEEE POPs Toys Product Safety Plant Protection Products Biocidal products

3 Products vs Article EU definitions in REACH Products = Chemical substances and mixtures Gases, powder and liquids chemical content Articles = Chemicals in products Form defines function not chemical content

4 EU legislation chemicals in products RoHS-directive (2011/65/EC) - brominated flameretardents - Pb, Cd, Hg, Cr VI - Phtalates 2019 POPs-regulation Reach-regulation (EC 1907/2006) - Azodyes - Pb, Cd, Ni - Hg - SVHC article 33: - Phtalates (EC 850/2004) - Flame retardents - SCCP - PFOS Toys safety directive (2009/48/EC) - 20 metals: Pb, Cd, Ni, Hg - 6 Phtalates - Perfume substances Biocide regulation (EU 528/2012) - Article 58: Biocide treated products

5 Product Safety Directive Consumer products not covered by specific sector legislation Generic definition of safe product Not only chemical risks RAPEX, Rapid alert system ( n.htm)

6 The toy safety directive Toys, including the chemicals they contain, shall not possess a risk to the user or any other person's safety or health when used as intended or predictable way considering the child's behavior. CE label is needed when placing in the market DoC EU Declaration of Conformity Technical documentation Safety assessment

7 Regulation of chemicals in the Toys safety directive Migration limits for 19 substances (mainly heavy metals) 55 allergenic fragrances prohibited. 11 substances must be specified on the label Substances classified as CMR (cat 1A, 1B and 2) are prohibted in concentrations higher than the level of classification Nitrosamines and N-nitrosatable substances are prohibited in toys for children under 36 months intended to be put in the mouth

8 REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Five principles: shift of responsibilities from public authorities towards industry (shift of burden of proof) duty of care no data, no market a strong European Chemicals Agency (ECHA) special attention to SMEs

9 Restrictions Annex XVII May be applied to: manufacture, use and placing on the market a substance on its own, in a preparation or in an article When: an unacceptable risk to human health or the environment the risk needs to be addressed on a Community-wide basis

10 Restrictions in Annex XVII Restricted substances 63 entries Examples: Hg entry18 Cd entry 23 Ni entry 27 Azo dyes entry 43 PAH entry 50 Phtalates entry 51,52 Pb entry 63

11 Phtalates entry 51and 52 DEHP bis (2-ethylhexyl) phthalate DBP dibutyl phthalate BBP benzyl butyl phthalate DINP di-isononyl phthalate DIDP di-isodecyl phthalate DNOP di-n-octyl phthalate Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material, and which can be placed in the mouth by children, shall not be placed on the market.

12 Standard GB New standard in China

13 Reach - Information obligations Article 33 Any supplier of an article which contains substances on the Candidate List in a concentration above 0.1% has to provide sufficient information, available to the supplier: to the recipients (professional and industrial users, distributors) and on request, to a consumer - free of charge - within 45 days of the receipt of the request This information must ensure safe use of the article including as a minimum the name of the substance

14 Candidate list substances SVHC Carcinogenic, mutagenic or toxic to reproduction (CMR) Persistent, bioaccumulating and toxic (PBT) Very persistent and very bioaccumulating (vpvb) Evidence for equivalent level of concern, such as endocrine disruptors Today 168 substances

15 POP regulation POP = persistent organic pollutants The POPs Regulation implements the Stockholm Convention by banning or restricting the use of POP substances in both chemical products and articles. The Regulation also contains provisions on the unintentionally produced POP emissions in the form of the POPs Protocol on Heavy Metals within the framework of the Geneva Convention on Long-Range, Transboundary Air Pollution (CLRTAP). Article 3: 1. The production, placing on the market and use of substances listed in Annex I, whether on their own, in preparations or as constituents of articles, shall be prohibited. Annex 1 contains List of substances

16 POP substances Examples: PFOS Limit: 0,001 % in substances or preparations 0,1% semi-finished products or articles SCCP Limit: 1 % in substances or preparations 0,15 % in articles (chemicals in products)

17 Biocidal Products Treated articles shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with are approved for the relevant product type and use. Special labelling requirements for treated articles apply from 1 September Examples of biocide treated articles; Mosquito net treated with insecticide Articles treated with anti-bacterial agent such as shoes, socks, training clothes

18 Labelling of biocide treated articles 1. Statement that the article incorporates biocidal products 2. Biocidal property 3. Name of all active substances contained in the biocidal product 4. Name of all nanomaterials contained in the biocidal product 5. Instructions for use, incl. precautions

19 RoHS Contains restriction (0,1%) of the use of certain hazardous substances in electrical and electronic equipment Cadmium (0,01 %) Mercury Lead Hexavalent chromium Flame retardants PBB Reduce the risks to human and PBDE health and the environment by substituting the following substances with less hazardous alternatives: Phtalates 2019; DEHP, DBP, BBP, DIBP

20 More information Chemical substances in articles - legislation Toys directive - chemical requirements Dangerous metals in jewellery