Each EU manufacturer of substances in quantities of 1 tonne or more per year, and each importer of a substance, either on its own or in a preparation, in quantities of 1 tonne or more per year, has to submit a registration to the European Chemicals Agency. Subject only to limited exceptions for certain "phase-in" substances, such substances may not be manufactured or imported before a period of 60 days after the registration if there are no objections from the EU Member State authorities.*
The registered information must include a technical dossier compliant with the requirements of Annexes V to IX (the level of technical information submitted varies, depending on the yearly tonnage, i.e., 1 tonne or more, 10 tonnes or more, 100 tonnes or more, and 1 000 tonnes or more), and a chemical safety report compliant with Annex I to the draft REACH Regulation. The safety assessment is a risk assessment in which the registrant takes account of the risk management measures that he either implements himself or proposes to downstream users. It will be important to ascertain whether and in what respect the "Chemical Safety Report" will differ from the classic model of risk assessment.
Manufacturers and/or importers may form a consortium for purposes of registration. The registration data may be submitted by one participant in the consortium on behalf of the other participants (with the exception of confidentially sensitive information).
Substances in articles are also subject to registration, if they are contained in articles in quantities above 1 tonne and if they are released during normal and foreseeable conditions of use and disposal in "sufficiently high amounts" so as to adversely affect human health and the environment. Registration is not required for substances in articles that have already been registered by an actor up in the supply chain.
Issues of concern
The information submitted for registration by the registrant must represent at least 90% of the registrant's own uses and the intended uses (e.g., by downstream users). This may create a substantial burden on manufacturers of substances with multiple downstream uses.
It is not clear whether, and under what conditions, downstream users may participate in industry consortia organized for purposes of registration.
Key terms used to define the registration of articles - e.g., "normal and reasonably foreseeable conditions of use and disposal", "released in sufficiently high amounts" and "human health and the environment are not adversely affected" - are themselves not defined, are highly subjective and, accordingly, may be interpreted in any number of ways.
It is not clear which companies will be able to benefit from the "phase-in" provisions, i.e., whether these provisions will only be applicable to companies who have manufactured or imported "phase-in" substances prior to the entry into force of the Regulation, or whether they will apply to any company marketing a "phase-in" substance after the entry into force of the Regulation, irrespective of its presence on the EU market prior to the entry into force.
The completeness check is conducted by the Agency, but a final rejection decision is taken by the Member State. It does not appear, however, that the Member State has any discretion. Accordingly, if the Member State is bound to follow the Agency's opinion, it is unclear whether and under what conditions a decision to reject a registration taken either by the Agency or by the Member State can be legally challenged.
With respect to "further duties of registrants", they are responsible for informing the Agency in writing of any significant changes in the annual or total quantities manufactured or imported. It is unclear what "significant changes" would mean, given that in any case further information must be submitted when another registration threshold is reached.
For phase-in substances, only those that were marketed in quantities above 1 tonne before the entry into force of the REACH Regulation may benefit from the phase-in provisions. No justification is provided for the imposition of such threshold.
Specific "phase-in" provisions apply generally to substances which are "classified" as CMRs category 1 or 2 in accordance with Directive 67/548/EEC, but apply to polymers which "meet the criteria for classification" in accordance with Directive 67/548/EEC. It is not clear why a distinction has been drawn between substances which are "classified" versus polymers "meeting the criteria for classification", nor is it clear on what basis, or by whom, a decision will be made that a polymer "meets the criteria for classification."
The Commission is empowered to amend the provisions related to the registration of polymers (specifically, which polymers are subject to registration), and therefore may either extend the category of polymers subject to registration or reduce it. As any such amendment would effect a substantial change to the regulation, as opposed to a technical change, only the Council and the European Parliament should be able to implement it.
( The provisions related to registration are included in Points 8 to 25 of the Regulation. The provisions related to the registration of substances in articles are included in Point 64 of the Regulation.)
* Substances used only in medicinal products, animal nutrition, plant protection products or biocides are exempted from the registration requirements. Substances used only as food additives, flavorings or additives in feedingstuffs, or intended for product and process oriented research are also exempted. Certain polymers and intermediates are subject to reduced registration requirements.
Last Updated: May 2003