Within REACH
22 December 2008 Now we know – REACH (Registration, Evaluation and Authorisation of CHemicals) will come into force on June 1. REACH has been a long time in gestation, with a history going back to 1998 when the EU decided that the regulatory system for chemicals was no longer “fit for purpose.”
Thus, in April 1998, a discussion started among the Council of Environmental Ministers about a new chemicals policy for those chemicals that had not been systematically investigated for hazardous properties, i.e., the EINECS (European Inventory of Existing Chemical Substances) list, which contains 100,106 so-called “existing substances,” of which approximately 30,000 are actually marketed. New chemical substances brought to the market after the closure of EINECS (termed “new” chemicals) had to undergo extensive physico-chemical and toxicological testing. These are listed on the ELINCS (European List of Notified Chemical Substances) list. ELINCS currently contains some 4,800 chemical substances.
Attempts have been made to carry out risk assessments on “existing substances,” but the process was slow, cumbersome, and resource intensive. Since 1993, only 140 high volume (>1,000 tonnes) chemicals have been selected as high priority for risk assessment, and final reports are available for only half of these.
Following the discussions begun in 1998, public consultations, political debate, and three years of negotiation between the Council of Ministers and the European Parliament, REACH was endorsed by Parliament on December 13, 2006 and enters into force on June 1.
What It Means
Under REACH, all manufacturers and importers must register substances that they produce or import in quantities over one tonne per year. This includes individual substances, substances in mixtures or preparations, and in certain cases, in articles. It is important to note that the registrants must be based in the EU and should have intimate knowledge of the substance, preparation, or mixture and article in question.
Downstream users are also implicated in the REACH process, as they must inform their suppliers of the use of a substance, so that appropriate safety assessments can be carried out, or they will need to carry out their own assessments for submission.
The whole procedure will be overseen by the European Chemicals Agency, based in Helsinki, which should become fully operational in June 2008. The requirements are detailed in the REACH regulation published in the Official Journal on December 30, 2006 [Regulation (EC) No. 1907/2006 of the European Parliament and of the Council].
The REACH procedure involves several steps, the first of which is the pre-registration of “phase-in” substances. These are substances which are listed in EINECS and were manufactured in the past 15 years, but not placed on the market or are “no longer polymers.” This initial phase will last from June 2008 until November 2008 and will enable the agency to draw up a database which will facilitate the setting up of Substance Information Exchange Fora (SIEF). The SIEF will oblige registrants to share data via consortia, except under specific circumstances, and thus avoid duplication of effort, particularly for vertebrate studies. The pre-registration phase is next followed by the registration process. The deadlines for registration are as follows:
- November 2010: Substances in quantities of 1,000 tonnes and above per year as well as carcinogens, mutagens, and substances toxic to reproduction above 1 tonne per year, and substances classified as very toxic to aquatic organisms above 100 tonnes.
- June 2013: Substances in quantities of 100 tonnes and above per year, as well as substances toxic for the aquatic environment.
- June 2018: Substances in quantities of 1 tonne or more.
All new substances must be registered before they can be placed on the market.
The Dossier
The technical dossier for registration must include results of various physicochemical, toxicological, ecotoxicological, and environmental tests. The extent and nature of these tests depend on the annual tonnage and becomes more demanding with increases in the tonnage levels. Based on the results, a chemical safety assessment must be prepared for all substances marketed in quantities of 10 tonnes or more per year per registrant. This assessment, which is included in a Chemical Safety Report, should consider all stages of the life-cycle resulting from the manufacture and all uses, including those indicated by downstream users. It should be based on a comparison of the potential adverse effects of the substance with the known or reasonably foreseeable exposure of man and/or the environment. For certain substances, including those classified as dangerous or persistent, bioaccumulative, and toxic, a Safety Data Sheet is also required, which can be passed to other users.
The next step in the process is evaluation which provides a follow-up to registration by allowing for checks on whether registrations are in compliance with the requirements of the REACH procedure. This follow-up, carried out by the competent authorities in the EU member states, will focus on a dossier of one registrant or consortium. In addition, the evaluation will assess any proposals for new tests, particularly those involving vertebrate animals.
Evaluation may lead to the conclusion that action should be taken under the restriction or authorization procedures. Those substances which may come under the authorization procedure include those classified as category 1 or 2 carcinogens or category 1 or 2 mutagens, persistent, bioaccumulative, and toxic substances, and very persistent and very bioaccumulative substances. The authorization system is intended to ensure that such substances will be progressively replaced. Authorization may be granted if the risk to human health or the environment from the use of the substance can be adequately controlled, taking into account all discharges, emissions, and losses. In certain exceptional cases where adequate control is not possible, authorization may be granted based on a socio-economic analysis, and if no suitable alternatives are available. However, authorizations are time-limited and all applicants for authorization should provide an analysis of alternatives and any research and development program aimed at finding suitable alternatives.
REACH In Crop Protection
For the crop protection industry, it might be thought that given the stringent safety requirements demanded under Directive 91 /414 for plant protection products, including both active substances and co-formulants, that these would be exempt under the REACH legislation. Indeed, one important aspect of the new legislation was to ensure that there was no overlap with substances already adequately controlled by existing legislation. However, despite the need to avoid overlaps, the wording of the relevant part of the regulation (Article 15) is such that although pesticides on Annex I are exempt from registration, co-formulants will still fall under the remit of REACH and thus need to be registered.
The crop protection industry will also be affected by the general impact from REACH in that there is likely to be an increased cost of chemicals, and some chemical substances may not be supported and will be removed from the market. Hence, the supply and cost of starting materials, which will need to be registered under REACH, for the production of pesticides may be affected, and there may be a need to reformulate if certain substances are withdrawn.
Additionally, as isolated intermediates fall within REACH, manufacturers will need to go through the registration process even if they do not leave the factory. As REACH covers all chemicals, there may also be an indirect impact if chemicals used in producing the finished product, for example, printing inks or glues, are affected.
All in all it is difficult to estimate the exact impact of REACH on the crop protection industry, but there will be an impact related to direct effects such as the additional costs of chemical substances, the withdrawal of certain substances, and possible reformulation costs, registration costs of starting materials, intermediates, and co-formulants, and possible indirect effects on other aspects of producing finished products.
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