Registration
The cornerstone of REACH is the so-called ‘no data, no market’ provision according to which substances (on their own, in mixtures, or in articles) may not be manufactured in the EU or placed on the market unless they have been registered, provided that no specific exemption applies (Art 5). It should be noted that registration is thus a requirement not only for the placing on the market but also for the manufacturing of chemical substances within the EU, even if the substances are manufactured solely for export. As will be shown, the exemptions are rather extensive, and with respect to substances in articles it is only under specific circumstances that an obligation to register applies.
Generally exempted from the registration requirement are substances, typically of natural origin, listed in Annex IV (among them glucose, lactose, nitrogen, and carbon dioxide), since they are considered to cause minimum risk due to their intrinsic properties, and those listed in Annex V (among them minerals, ores, natural gas, crude oil, and coal, provided that they are not chemically modified), as registration is deemed inappropriate or unnecessary for these substances (Art 2).
Of more importance is, however, the volume threshold according to which only those who manufacture or import a substance, either on its own or in mixtures, in quantities of one tonne or more per year need submit a registration to ECHA (Art 6). A substance can thus be manufactured and imported by any number of actors without being registered as long as none of them reaches the one tonne/year threshold. The total volume of an unregistered substance that is introduced on the market can in this way be well above one tonne/year.
Substances that have been notified in accordance with Directive 67/548/EEC, that is, so-called ‘new substances’, are to be regarded as registered under REACH (Art 24).
Active substances[1] [2] [3] manufactured or imported for use in plant protection products or biocidal products only and approved under relevant EU legislation on such products are also regarded as having been registered and need not be registered under REACH (Art 15).
Specific exemptions apply in certain cases to monomers that are used as so- called on-site isolated intermediates or transported isolated intermediates, and to polymersi7 (Art 6). When on-site isolated intermediates are to be registered they are subject to specific rules. Polymers, which include plastics, may become subject to registration and evaluation requirements in the future if it becomes possible to select those that need to be registered due to the risks posed to human health or the environment in a practicable and cost-efficient wayd8
With respect to articles, producers or importers are normally only required to submit a registration for any substance contained in those articles if the substance is present in quantities totalling over one tonne per producer or importer per year and if the substance is intended to be released under normal or reasonably foreseeable conditions of use (Art 7). That an article contains a substance is thus not in itself sufficient to trigger an obligation to register the substance, irrespective of the volumes involved. It must also be intended to be released. The numerous substances that make up a laptop need, for example, not be registered, for that reason at least, since laptops are not intended to release their constituent chemicals.
Certain time-limited exemptions from the duty to register apply with respect to substances manufactured or imported for the purposes of product and process- orientated research and development (Art 9).
It is important to note that substances that are exempted from the obligation to register may still be subject to authorisation or restriction provisions under REACH.
The information to be included in the registration, and thus sent to ECHA, varies depending on the volumes of the substance that the individual registrant imports or places on the market. However, all registrants must submit a technical dossier containing information on, inter alia, the manufacture and use(s) of the substance, its classification and labelling, and guidance on how it may be used safely. The requirements are specified in Annex VI. (Art 10.)
All the physicochemical, toxicological, and ecotoxicological information that is relevant and available to the registrant must also be included in the technical dossier, regardless of volume. But depending on the volume, specific minimum requirements apply which may go beyond what is already available to the registrant. For substances manufactured or imported in quantities of one tonne or more per year per manufacturer/importer, the information specified in Annex VII must be provided. For volumes of10 tonnes and above, the information required by Annex VIII is added. Registrations concerning substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer/importer must also contain testing proposals for the provision of the information specified in Annex IX. For volumes of 1,000 tonnes and above, further testing proposals in accordance with Annex X must also be provided.
The testing proposals included in registrations are examined by ECHA according to a certain order of priority. A decision is then made, in accordance with a certain procedure, on which of the tests are to be carried out, which conditions shall apply, and if any further tests will be required. (Arts 12 and 40.)
In order to increase the efficiency of the registration system, reduce costs, and reduce testing on vertebrate animals, a system for joint submission of data by multiple registrants applies. When more than one manufacturer and/or importer are required to register the same substance, certain information, including proposals for testing, is to be submitted by one registrant acting with the agreement of the other assenting registrants (‘the lead registrant’). However, a registrant may submit this information separately, for example if it would be disproportionately costly for her to submit the information jointly, or if she disagrees with the lead registrant on the selection of information. (Art 11.)
When a registration reaches ECHA, the agency carries out a completeness check to ascertain that all the elements required have been provided and assigns a registration number to the substance concerned. The check does not include an assessment of the quality or the adequacy of any data or justifications submitted. Such a check is only required to be carried out on a minimum of 5 per cent of the dossiers received for each tonnage band. The quite limited extent to which ECHA tries to ensure that registrations are in compliance with the substantive requirements of REACH is obviously related to resources, but should also be understood against the fact that the primary aim of the registration procedure is not to provide the agency with comprehensive information. The main objective is to make manufacturers and importers generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances, and to develop appropriate risk management measures which may be applied by themselves and in the supply chain.[4]
Unless the agency informs the registrant, within three weeks after the submission date, that her registration is incomplete, the registrant may start or continue (for so-called phase-in substances) to manufacture or import the substance or article in question. (Arts 20, 21, and 41.)
Registrants must under certain circumstances update the registration. That applies, inter alia, when changes in the quantities manufactured or imported result in a change of tonnage band, when there is new knowledge of the risks of the substance to human health and/or the environment which leads to changes in the safety data sheet or the chemical safety report, or if there is a change in the classification and labelling of the substance. (Art 22.)
To avoid overloading authorities and others, registration of so-called ‘phase-in substances’—including the ‘existing substances’ listed in EINECS, and substances manufactured in the EU but not placed on the market before REACH came into effect—has been spread out over a number of years. For a potential registrant of a phase-in substance to benefit from the transitional regime, the registrant had to preregister the substance with ECHA in 2008. (Art 28.)
The following phase-in substances needed to be registered no later than 1 December 2010: substances classified as carcinogenic, mutagenic, or toxic to reproduction and manufactured in the EU or imported, in quantities reaching one tonne or more per year per manufacturer/importer, at least once after 1 June 2007; substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment and manufactured or imported in quantities reaching 100 tonnes or more per year per manufacturer/importer, at least once after 1 June 2007; and other substances manufactured or imported, in quantities reaching 1,000 tonnes or more per year per manufacturer/importer, at least once after 1 June 2007.
For other substances manufactured or imported, in quantities reaching 100 tonnes or more per year per manufacturer/importer, at least once after 1 June 2007, the deadline for registration was 1 June 2013. The last group of phase-in substances, that is, those manufactured in the EU or imported in quantities reaching one tonne or more per year per manufacturer/i mporter at least once after 1 June 2007, but not falling within any of the above categories, are exempted from the registration requirement until 1 June 2018. Substances with known problematic properties and those manufactured or imported in large volumes were thus required to register before those without such known properties and handled in smaller volumes.
Title III of the Regulation lays down rules on data sharing and avoidance of unnecessary testing. The sharing of information on substances is intended to increase the efficiency of the registration system, reduce costs, and reduce the need for testing on vertebrate animals. For this purpose everyone who pre-registered a phase-in substance shall participate in a substance information exchange forum (SIEF). The sharing of information shall concern technical data and in particular information related to the intrinsic properties of substances. Testing on vertebrate animals shall be undertaken only as a last resort. (Arts 25 and 29.)
As of mid-2015, ECHA had received about 40,000 registrations of phase-in substances involving 7,250 unique substances. Since 1 June 2008 it had also received about 3,100 registrations of non phase-in substances, involving 1,400 unique substances.20 [5]
- [1] Regarding active substances see further section 13.4.1.
- [2] The concept of ‘monomer substance’, as used in REACH, has been subject to interpretation bythe Court of Justice in Case C-558/07 S P CMand Others ECLI:EU:C:2009:430. ‘Isolated intermediates’ should be contrasted with ‘non-isolated intermediates’ which are intermediates that, during synthesis, are not intentionally removed from the equipment in which the synthesis takes place (Art 3).
- [3] Preambular para 41.
- [4] Preambular paras 19—21.
- [5] Registration statistics
