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UPDATE ON REACH - NEW OBLIGATIONS

23rd May, 2011

The Reach Regulations are beginning to bite. The first round of Registration - for substances supplied at more than 1000 tonnes pa - was completed by 30 November 2010, and the next rounds, for more specialised chemicals, are due by 31 May 2013 for those supplied at more than 100 tonnes pa - and by 31 May 2018 for those supplied at more than 1 tonne pa.

The next key milestone, which will affect companies importing and supplying products into the European Union, is the requirement to notify to the European Chemicals Agency by 1 June 2011 all candidate list substances in articles above defined thresholds.

There are already some obligations on importers and suppliers of articles, or products, where they contain Substances of Very High Concern (SVHCs) - the full current list of which is given in Table 1. These existing obligations are set out in Article 33 of the REACH Regulation and are spelt out in revised guidance on the ECHA website http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf

Briefly, any supplier of articles containing a SVHC at a concentration above 0.1% (w/w) has to provide available, relevant safety information about the substance to the recipients of these articles. The information is to be provided to the recipients automatically, i.e. as soon as the substance has been included on the Candidate List. On request from a consumer the same information has to be provided within 45 calendar days of the request and free of charge.

These obligations also apply to articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Therefore the relevant date is when the article is supplied and suppliers, including retailers, need to keep abreast of which substances are classed as SVHCs.

NEW OBLIGATIONS TO NOTIFY ECHA

The new obligation from 1 June 2011 is that producers and importers of articles have a legal obligation to submit a notification to ECHA with regard to any SVHC on the Candidate List in their articles, if both the following conditions are met:

  • The substance is present in their relevant articles above a concentration of 0,1% weight by weight, and
  • The substance is present in these relevant articles in quantities totalling over 1 tonne per year (the 1 tonne refers to presence of the substance in all products handled by the same supplier/importer where the concentration is 0.1% or more)

However, there are also some exemptions from the obligation to notify. A notification will not be required if:

  • The producer or importer of an article can exclude exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use including the disposal of the article (where appropriate instructions need to be supplied to the recipient); or

The obligation to notify is established in article 7(2) of the REACH Regulation, and broadly, ECHA appear to be trying to make it difficult to qualify for any exemption from the requirement.

Companies will have to notify not later than 6 months after the inclusion of the substance in the Candidate List and notifications for substances included before 1 December 2010 must be submitted not later than 1 June 2011.

Information to be notified

The information required comprises:

  • the identity and contact details of the producer or importer of the articles
  • the registration number for the substance, if available
  • the identity of the SVHC (from the Candidate List)
  • the classification of the substance (from the Candidate List and supporting documentation)
  • a brief description of the use(s) of the substance in the article(s) and the uses of the articles
  • the tonnage range of the substance contained in the articles,

Substances subject to Authorisation

The first list of substances formally added to Annex XIV of the REACH Regulation - those to be subject to Authorisation - was set out in Commission Regulation 143/2011. This establishes application dates by which detailed requests for authorisation have to be made, and "sunset" dates, after which, the use and placing of the substances on the market is prohibited if no authorisation has been granted. These first substances are:

Substances

  • 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) - Sunset Date : 21 July 2014
  • 4,4"-Diaminodiphenylmethane (MDA) - Sunset Date : 21 July 2014
  • Hexabromocyclododecane HBCDD), and all major diastereoisomers identified, i.e.: alpha-, beta-and gamma- hexabromocyclododecane - Sunset Date: 21 July 2015
  • Bis(2-ethylhexyl) phthalate (DEHP) Sunset Date: 21 January 2015
  • Benzyl butyl phthalate (BBP) - Sunset Date : 21 January 2015
  • Dibutyl phthalate (DBP) - Sunset Date: 21 January 2015

While the current focus is on these substances, there appears to be no specific part of the REACH Regulation that would automatically prohibit these substances from being present in imported articles. The only reference to such substances in articles is the possibility of specific restrictions being implemented via Annex XVII, which lists - "Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles".

So companies importing articles into Europe need to understand what is in them and to establish whether they need to notify any of the substances to ECHA.

BLC offers a comprehensive package of REACH support including technical advice, risk assessments and REACH screening and SVHC testing for leather, footwear and accessories . For further information contact Tori Moreno Cruse on tori@blcleathertech.com .

BLC members receive 30% discount on testing, training and consultancy.

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