|Title:||Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC|
|Topic:||Regulation establishing an agency to monitor chemicals in the E.U., and creating principles for the registration and evaluation of such chemicals|
|Direct / indirect relevance||Indirect. The focus of the text is on biochemical safety, which indirectly implies ICT-RM/RA obligations.|
|Scope:||Directly applicable to the practices governed by the regulation|
|Legal force:||Directly binding to the affected bodies|
|Affected sectors:||Biochemical sector (including both manufacturers and importers of the substances involved)|
|Relevant provision(s):||The regulation, spanning 849 pages, includes a multitude of provisions directly related to risk management. Since risk management is a continuous consideration in this document, it would be infeasible to provide a representative overview in a reasonable manner. Relevant provisions include the following (by way of non-exhaustive example):
Article 14 - Chemical safety report and duty to apply and recommend risk reduction measures
1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant.
The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or in an article or a group of substances.
2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lowest of any of the following:
3. A chemical safety assessment of a substance shall include the following steps:
(a) human health hazard assessment;
(b) physicochemical hazard assessment;
(c) environmental hazard assessment;
(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
(a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;
(b) risk characterisation.
The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.
5. The chemical safety report need not include consideration of the risks to human health from the following end uses:
(a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food;
(b) in cosmetic products within the scope of Directive 76/768/EEC.
6. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31.
7. Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.
Article 44 – Criteria for substance evaluation
1. In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:
(a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
(b) exposure information;
(c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.
2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The
Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year.
|Relevance to RM/RA:||The regulation implants RM/RA obligations by:
• Imposing a reporting obligation, including on producers and importers of articles covered by the Regulation, with regard to the qualities of certain chemical substances, which includes a risk assessment and obligation to examine how such risks can be managed. This information is to be registered in a central database. A European Chemicals Agency will act as the central point in the REACH system (Registration, Evaluation, Authorisation and restrictions of CHemicals;
• Establishing a Committee for Risk Assessment within the European Chemicals Agency established by the Regulation;
• Requiring that the information provided is kept up to date with regard to potential risks to human health or the environment, and that such risks are adequately managed;