EU Chemicals - REACH
REACH (Registration, Evaluation and Authorisation of Chemicals) enters into force on 1 June 2007. It is a complete and radical review of the EU's chemical substances policy.
REACH is extremely wide in scope, covering all substances whether manufactured, imported, used as intermediates or placed on the EU market, either on their own, in preparations or in articles. There are a number of exemptions, however these are limited.
REACH imposes a general obligation on manufacturers and importers to submit a registration dossier to the European Chemicals Agency (ECHA) for each substance manufactured or imported in quantities of one tonne or more per year. The registration dossier consists of a technical dossier and a chemical safety report (CSR) for substances in quantities of ten tonnes or more. The technical dossier must contain information on the properties, uses and classification of a substance as well as guidance on safe use. The CSR documents include, for example, the classification of a substance and its hazards. A registration dossier can only be submitted by a manufacturer or importer established within the EU. Therefore, if a non-EU manufacturer wishes to continue to supply a chemical substance within the EU, it must either ensure that its importer registers the substance or alternatively he can appoint an “Only Representative”, established within the EU, to register on his behalf.
It is estimated that more than 30,000 chemical substances will need to be registered. As of 1 June 2008 a “non phase-in”, ie, new, substance must be registered before it is placed on the market. As for “phase-in”, ie, existing, substances, the Commission has provided a transitional period of 11 years within which all registrations must be completed. The exact deadline will depend upon the annual volume of the chemical substance which is manufactured or imported. In order to benefit from the transitional period manufacturers and importers need to pre-register their “phase-in” substances.
REACH also affects downstream users and distributors. Downstream users and distributors form an important part of the REACH system as they occupy the role of intermediaries between manufacturers and/or importers and consumers/downstream users. REACH imposes obligations on downstream users and distributors to provide their customers with information, including appropriate risk management measures, and to inform manufacturers and/or importers of hazardous properties and new uses. Downstream users and distributors are also subject to reporting and record keeping obligations.
A considerable amount of data will need to be collected before a dossier is acceptable for chemical substance registration. REACH focuses upon data sharing as a means of reducing the amount of animal and other testing. Registrants of “phase-in” substances are obliged to, and other data holders (such as downstream users) may, participate in a substance information exchange forum (SIEF), which is an electronic forum that facilitates the exchange of information. REACH also seeks to ensure that small and medium sized entities do not become over burdened by the registration requirements. Accordingly, REACH introduces the ‘one substance one registration’ principle. Pursuant to this principle, registrants are obliged to submit parts of their registration dossier jointly. Only one registration dossier is permitted per substance. A registrant can only register separately in limited circumstances. As such, co-operation is compulsory rather than voluntary under the REACH regime.
The introduction of the ‘one substance one registration’ principle, the data sharing and SIEF obligations compel industry to co-operate. However, REACH does not provide for sufficient guarantees as to the protection of IP rights and know how. In order to ensure such protection, it is highly advisable for registrants to put their co-operation on a contractual footing. This is best achieved by the formation of consortia. The advantages of this approach include data protection and substantial cost savings. Each consortium will focus upon developing the information required for the substances that are common to its members.
REACH obligations will be enforced by the Member States. A forum, composed of representatives from the Member States, will co-ordinate the sanctions regime. Member States will set the appropriate penalties for infringements and will be empowered to impose fines, and potentially criminal sanctions, which are proportionate to the extent and impact of non-compliance.
Contacts
- Scott S. Megregian
+44 20 7577 6911
Send E-mail - Frank Schoneveld
+32 2 282 35 83
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