Environmental Protection: Chemicals
EU chemicals policy - REACH
Questions and answers: Authorisation and restriction
What is ‘Authorisation’?
For substances of very high concern (SVHC), an authorisation is required for their use and their placing on the market. The substances required to be authorised are those:
- that are carcinogenic, mutagenic or toxic for reproduction (CMRs) category 1 and 2,
- that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs) according to given criteria, and/or
- that give rise to an ‘equivalent level of concern’ to those mentioned above where there is scientific evidence of probable serious effects to humans or the environment (e.g. endocrine disruptors) which will be identified on a case-by-case basis.
These substances are considered to have hazardous properties of such high concern that it is necessary to regulate them centrally through a mechanism that ensures that the risks related to their actual uses are assessed, considered and then decided upon on an EU-wide basis. The justification is that the effects on humans and the environment of these substances are very serious and normally irreversible. Substances that fall into these categories will be fed into the authorisation system as resources allow. Their use will be banned unless industry can justify continued use, either because the risks are adequately controlled, or the socio-economic benefits outweigh the risks. In both cases there must also be no safer alternatives.
What are main elements of the authorisation process in the REACH Regulation
The following key elements are included:
Article 57(f) provides a safety net to catch ‘substances of equivalent concern’. Substances such as endocrine disruptors could on a case by case basis come within the scope of authorisation where there is scientific evidence of probable serious effects to humans and the environment giving rise to an equivalent level of concern.
Authorisations may be granted through either the ‘adequate control’ or ‘socio-economic‘ routes. However, the adequate control route cannot apply to PBTs, vPvBs (including substances of equivalent concern which have PBTs or vPvBs properties), and non threshold CMRs, as it is not possible to determine a threshold in accordance with Annex I, section 6.4.
All applications for an authorisation must be accompanied by an analysis of possible alternatives considering their risks and the technical and economic feasibility of substitution. Where a safer alternative is identified, applications must also include a substitution plan giving details of how and when substitution will take place.
All authorisations are subject to a time-limited review, the period of which is set on a case-by-case basis. This enables further consideration of the availability of alternatives. In addition, an authorisation may be reviewed at any time should a third party supply new information on possible substitutes to the Agency.
When is a substance “adequately controlled”?
“Adequately controlled” refers to an exposure below a Derived No-Effect Level (DNEL), or threshold, for humans, or below a Predicted No-Effect Concentration (PNEC), or threshold, for the relevant environmental compartment (i.e. sphere of concern, e.g. aquatic/sediment, terrestrial, and atmospheric). Adequate control does not apply to substances where it is not possible to determine DNELs and PNECs, specifically: persistent, bioaccumulative, and toxic substances (PBT), very persistent and very bioaccumulative (vPvB), substances of equivalent concern which have PBTs or vPvBs properties, and non-threshold carcinogens, mutagens or reprotoxicants (CMRs). There will be a review of Annex I detailing how to prepare a CSA demonstrating adequate control by 1 June 2008.
How will substitution work under authorisations?
Applications for an authorisation will need to be accompanied by an analysis of possible alternatives considering their risks and the technical and economic feasibility of substitution. Where a suitable safer alternative is identified, applications must also include a substitution plan giving details of how and when the harmful substances will be replaced.
Why are there limits to when hazardous substances should be substituted?
Substitution is not a straightforward process. There have been a number of examples where an apparently safer substitute has been introduced in response to human health or environmental concerns only to turn out to have unintended effects of equal or greater consequence to that of the substance replaced. Also, substitution will normally present technical challenges –it is not simply a matter of replacing one substance with another, but can require extensive changes to manufacturing processes and product formulation.
Concerns were raised regarding the number of substances within the scope of the authorisation procedure and how to manage them with the limited resources and expertise available. Only a limited number of substances will be subject to authorisation each year; it will therefore be necessary to consider those of highest concern first. REACH therefore provides for authorisations based solely on adequate control, so that priority may be given to reviewing applications that of substances that present a higher potential risk.
Will there be a fee charged for authorisation?
Yes. The standard fee will be €50,000 (approx £37,000) per application, but there are reduced fees for SMEs in line with the requirements of the REACH Regulation. Full details are set-out in a European Commission Regulation to be in place by 1 June 2008, the text of which was adopted on 10 December 2007.
What is the process for Restrictions and why is it necessary?
The Restrictions procedure is designed as a safety net to enable conditions (up to and including prohibition) to be placed on the manufacture, placing on the market, or use of substances, on their own, in a preparation or in an article. Restrictions apply on a Community-wide basis if it can be demonstrated that the risk posed by the substance or use are not adequately controlled. Any uses/activities of a restricted substance which are not specifically covered by the restriction are allowed unless the substance is also included in the authorisation system.
Proposals for restrictions will be prepared by Member State competent authorities, or by the Agency on behalf of the Commission, in the form of a structured Dossier. This Dossier is required to demonstrate that there is a risk to human health or the environment that needs to be addressed at Community level, and that the most appropriate set of risk management measures have been identified. Deadlines for the procedure to result in a Commission decision are set out in detail in REACH to ensure rapid decisions. Interested parties will have an opportunity to comment on proposed restrictions, and the Agency will provide opinions on any proposed restriction.
The existing restrictions set out in the Marketing and Use Directive (76/769/EEC - such as the ban on asbestos and restrictions on the uses of certain azo-dyes) will be carried over in a consolidated version into Annex XVII.
Page published: 4 January 2008