REACH is the main general European chemicals regulation, which entered into force on 1 June 2007. Chemical producers and importers are required to provide data to the European Chemicals Agency on the substances they produce and/or import to demonstrate that they are being safely produced and used.
The acronym REACH takes its name from Registration, Evaluation, and Authorisation of CHemicals, the three main parts of the legislation. A fourth part of the legislation, namely restriction, does not appear in the acronym, yet it is one of the key elements.
Registration is the process by which chemical manufacturers and importers provide a technical dossier of data to European authorities in order to continue placing their substances on the European market. Registration is required for all substances manufactured and/or imported in quantities above 1 tonne per year. Every legal entity manufacturing and/or importing has to register under REACH, this also includes importers of mixtures containing substances.
Evaluation is a process where the authorities can request that registrants, and in very limited cases downstream users, provide further information on their substances. The two types of evaluation are:
Authorisation is a process involving substances which are placed on the REACH Candidate List due to certain hazardous properties (Category 1 and 2 Carcinogens, Mutagens and Reproductive (CMR) Agents; Persistent, Bioaccumulative, and Toxic substances (PBT); very Persistent and very Bioaccumulative (vPvB) substances). The manufacturers or importers placing the substance on the EU market for specific uses will have to apply to the European Chemicals Agency (ECHA) for Authorisation to continue marketing them beyond a certain date.
In certain situations downstream users may also apply for Authorisation. Authorisation involves review by the ECHA Risk Assessment Committee (RAC) and the ECHA Socio-Economic Analysis Committee (SEAC), with a final decision being taken by the Commission and Member States. Authorisations, if granted, are time limited and use specific. This is consistent with the intent of REACH which is to replace these substances where economically and technically feasible.
Under REACH any Member State or ECHA at the request of the Commission can propose specific restrictions on any substance if it is considered that there is a significant risk to health or the environment. An Annex XV Restrictions dossier must be prepared and this is assessed by the ECHA Risk Assessment Committee (RAC) and the ECHA Socio-Economic Analysis Committee (SEAC). Final decisions are taken by the Commission and Member States. A full list of all Restrictions is included as Annex XVII of the REACH regulation.
The most commonly used plasticisers, high phthalates DINP, DIDP, and DPHP have been registered well ahead of the deadline for substances produced in quantities greater thant 1000 tonnes per year of 30 November 2010. Their registration dossiers were submitted to the European Chemicals Agency (ECHA) between December 2009 and April 2010.
High phthalates manufacturers were committed to the objective of an early registration, and the process has certainly been facilitated by the fact that they are ‘data-rich’. High phthalates (DINP and DIDP) have undergone a comprehensive European Union Risk Assessments based on the European Union Regulation 793/93. This comprehensive review in involving the European Chemicals Bureau and Member State experts led to the conclusion that no hazard classification is required and that risk reduction is not required for current uses.
Furthermore, high phthalates are not classified as PBT or vPvB substances. They do not fulfill the criteria to be considered Substances of Very High Concern (SVHC) and therefore are not included on the EU REACH Candidate List nor do they need Authorisation to be placed on the EU market.
On the other hand, in October 2008, the low phthalates DEHP, DBP and BBP were included in the REACH “Candidate List” and in April 2009 ECHA proposed them for inclusion in the REACH Authorisation List (Annex XIV). The inclusion in the Authorisation List was confirmed officially in February 2011, with a phase-out date of February 2015 for these low phthalates unless they Authorised through submission of a dossier by manufacturers or users. Another low phthalate, DIBP, was proposed by Germany in September 2009 and was included on the REACH “Candidate List” in January 2010. As expected, these low phthalates were included on the list due to their EU hazardous classification. The full list of substances is available here.
In the case of low phthalates DEHP, DBP and BBP, they will have to undergo Authorisation. The main DEHP producer has already declared that they intend to seek Authorisation to ensure the continued availability of DEHP in the future.
The inclusion of DEHP, DBP, BBP and DIBP on the “candidate list” means that any EU manufacturer or importer of an article containing more than 0.1% weight by weight (w/w) of these phthalates must notify ECHA as of June 2011, unless the articles manufacturer or importer can clearly demonstate that their use has already been registered. In addition the article manufacturer or importer must now provide information to the recipient of that article. As a minimum, recipients – meaning anyone in the supply chain from distributors and retailers to professional end-users - need to be told that the article contains one or more of the substances.
Further down the supply chain, retailers also have an obligation to provide the same information to consumers, but only if a consumer requests it. A retailer has 45 days to provide the information.
The European producers of DINP, DEHP and phthalic anhydride have formed consortia for the purpose of sharing relevant research information and these consortia are responsible for the relevant REACH registration dossiers.
The consortia for DINP and DEHP/2EH/n and i-Butanal are managed by ReachCentrum, an independent service unit established by Cefic, the European Chemical Industry Council. If you are an importer or producer of these substances and wish to join one of the consortia please contact ReachCentrum: consortium[at]reachcentrum.eu, telephone +32 2 676 7400.
A consortium for the registration of phthalic anhydride has also been formed and is open to all potential registrants in the same SIEF. Members are willing to share data under cost compensation. For further information please contact: Mr. Louis Wyness or Mr. David Osborn, Direct Line: +44 (0) 1423 799 646, Main Office: +44 (0) 1423 799 633, Main Fax: +44 (0) 1423 797 804, email: Louis.Wyness[at]TSGEUROPE.COM