From 1 June 2009, Annex XVII of REACH takes effect, incorporating the previous restrictions in the Marketing and Use of Certain Dangerous Substances and Preparations Directive 76/769/EEC and amending the procedure by which new restrictions are proposed.
Restricted Substance Requirements
The superseded Marketing and Use Directive is more commonly known as its numerous amendments, which have now been consolidated and transposed into Annex XVII, for example:
- Azo colorants Directive 2002/61/EC
- Blue Colorant" Directive 2003/3/EC
- Cadmium Directive 91/338/EEC
- Nickel Directive 94/27/ EC
- Phthalates Directive 2005/84/EC
These requirements continue to apply regardless of the tonnage of the substance manufactured or imported (unlike other REACH requirements). As REACH is an EU Regulation these restrictions apply directly in each Member State without the need for further implementation (as was the case with the old Directive).
Despite the transposition, there are some minor differences between the amended 76/769/EEC and Annex XVII, of which the main ones are:
Cadmium
Annex XVII now clarifies that the restrictions apply to dried coatings of water- and solvent-based paints, varnishes, enamels and lacquers (based on synthetic or chemically-modified natural polymers) used to give color to finished articles or components of articles.
Confusion had arisen over the use in the Cadmium Directive 91/338/EEC of the EU Common Nomenclature (CN) Codes 3208 and 3209. These Customs Codes apply to the coatings in the liquid form, without the new clear link to articles and components using these materials.
In the Netherlands, the additional requirements of the Dutch Cadmium Decree have now been withdraw, to align fully with the EU REACH Annex XVII/Directive 91/338/EEC cadmium restrictions.
Nickel
The test methods to be used are now merely referred to as "The standards adopted by the European Committee for Standardization (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2nd. Technically this isn't a change as the current standards EN 1811:1999+A1:2008 and EN 12472:2005 will be used.
New Procedure for Restricting Substances
Under the new procedure an EU Member State, or on request from the Commission, the European Chemicals Agency (ECHA) may propose a new restriction for the manufacture, placing on the market or use of a dangerous substance, as such, or in preparations or in articles.
The First step will be submission of an Annex XV dossier which covers the hazards and risks posed, along with alternative substances/techniques to replace the substance, other EU legislative measures to deal with the issues, and a cost/benefit analysis for the proposal. The dossier, with commercially sensitive information removed, will be made available on the ECHA website.
The proposal is then considered by the ECHA's Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), which will also be published on the ECHA website. After this the Commission will prepare a draft amendment to Annex XVII to be voted on by the European Council (EU Member States) and considered by the European Parliament.
The ECHA maintains a Registry of Intentions for these proposed restrictions together with their Annex XV dossiers per the following link. This Registry also lists dossiers submitted for proposed substances of very high concern (SVHC) and for harmonized classification and labeling of CMRs, (carcinogenic, mutagenic or toxic for reproduction), respiratory sensitizers and other effects(CLH).
http://echa.europa.eu/chem_data/reg_intentions_en.asp
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