EU Regulatory Update: REACH Deadline fast approaching for notifying the European Chemicals Agency about the presence of 20 Candidate List substances in articles
Under the EU REACH legislation, EU producers and importers have only until 19 June 2012 to notify the European Chemicals Agency (ECHA) about the presence in certain of their products of 20 substances of very high concern. These substances are: 4-(1,1,3,3-tetramethylbutyl)phenol, N,N-dimethylacetamide, Phenolphthalein, Lead diazide - Lead azide, Lead dipicrate, Calcium arsenate, 1,2-dichloroethane, Dichromium tris(chromate), 2-Methoxyaniline - o-Anisidine, Pentazinc chromate octahydroxide, Aluminosilicate Refractory Ceramic Fibres, Arsenic acid, Potassium hydroxyoctaoxodizincatedichromate, Formaldehyde - oligomeric reaction products with aniline, Lead styphnate, Trilead diarsenate, Bis(2-methoxyethyl) phthalate, Zirconia Aluminosilicate Refractory Ceramic Fibres, Bis(2-methoxyethyl) ether, and 2,2'-dichloro-4,4'-methylenedianiline.
Under REACH, certain substances that may have serious and often irreversible effects on human health and the environment can be included on the Candidate List of Substances of Very High Concern (SVHCs) and their use may subsequently be made subject to an Authorisation decision of the European Commission.
The 20 substances listed above were added to the REACH Candidate List in December 2011, and consequently a six-month deadline to make a required notification to ECHA about their presence in certain of a company's products will expire on 19 June 2012. Companies which start to manufacture or import into the EU substances on the Candidate List after this notification deadline has expired should make the notification without undue delay as soon as these conditions related to the notification obligation are met.
Producers and importers in the EU are required under REACH to notify ECHA of the substances listed on the Candidate List present in their products under the following conditions:
- the products in question qualify as an "article" for purposes of REACH;
- one of the SVHC substances is present in those products above a concentration of 0.1% weight by weight; and
- the substance is present in those products in quantities totalling over one tonne per producer or importer per year in the EU.
For purposes of REACH, an "article" is an object which during production is given a special shape, surface or design, which determines its function to a greater degree than does its chemical composition. A car, a battery, and a telephone are examples of articles.
Notification is not required where the producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article, including its disposal. In these cases, the producers and importers must only give appropriate instructions to the recipient of the article.
The EU REACH legislation requires that EU member states introduce penalties for non-compliance with its provisions. For example, in the UK, national enforcement provisions provide maximum penalties of an unlimited fine and/or up to two years' imprisonment following conviction on indictment for relevant infringements.
In order to obtain assistance for compliance with the EU REACH legislation or any other EU regulatory issues, please contact those listed below, or your regular Crowell & Moring contact.
Please contact firstname.lastname@example.org for more information.