EU Regulatory Bulletin contents
- BPR Adopted
- Pesticides Update
- ECHA & Information disclosure
- REACH scope review
- BPA Developments
- Antitrust Manual
The European Commission has published the REACH Review study on the scope of REACH and other relevant EU legislation to assess overlaps.
The REACH Review study is conducted on the basis of Article 138(6) of REACH, which requires the Commission to carry a review by 1 June 2012 to assess whether or not to amend the scope of this Regulation to avoid overlaps with other relevant Community provisions and if appropriate, present a legislative proposal.
The study, prepared by consultants Milieu, compares REACH to 155 other EU legal acts in terms of aim and scope, definitions, specific links with REACH including exemptions, risk assessment methods, and risk management mechanisms.
The study provides 38 findings all with recommendations for action. The recommendations include amendments to legislation (both to REACH and sectoral legislation) as well as non-legislative options, such as the development of guidance
or Commission recommendations.
The study focuses on identifying possible overlaps with other EU legislation that might constitute instances of double regulation but also detects a number of gaps in the coverage provided by REACH and the sectoral legislation. Finally, it pinpoints specific interactions between REACH and other EU legislation that could lead to synergies, including enhanced protection for human health, reduced administrative costs for dutyholders, and incentives for innovation.
‘Double Regulation’, as used in the study, refers to when two pieces of legislation regulate the same situation and this results in an inconsistency and/or a duplication in the requirements for dutyholders.
A number of legislative acts include provisions with restrictions on certain substances or certain uses of those substances that are similar or inconsistent with the restrictions described in REACH Annex XVII.. The report suggests setting up a database that would serve as an inventory of all restrictions in place for particular substances as well as revising legislation to remove any duplications and inconsistencies.
The study found instances of double regulation with REACH in, amongst other things, the Classification & Labelling Regulation (CLP), the Plant Protection Products Regulation (PPPR), the Biocidal Products Directive (BPD), the Cosmetics Regulation, the Packaging Directive and the RoHS Directive.
The term 'Gap' is used where the REACH regulatory regime does not adequately cover a substance. For example a gap exists where substances are exempted from REACH (on the basis of a similar coverage under another legislative act) or are considered as registered, but where coverage or protection similar to that under REACH is not provided.
The study found that other legislation does not always provide for the same type of detailed substance-specific risk assessment required under REACH, with the result that there are gaps in the risk assessment as the manufacturing, formulation and waste management stages are not covered under sectoral legislation.
The study recommends amendments to the relevant sectoral legislation to align their risk assessment process with the life cycle approach of REACH .
The main regulatory gaps identified by the study, amonst others, include the Plant Protection Products Regulation, the Biocidal Products Directive, the Animal Testing Directive, the Cosmetics Regulation and the Food safety legislation.
The term 'Synergy' is used where specific interactions between REACH and other EU legislation could lead to enhanced protection, e.g., where the information on a chemical and its uses available under REACH will help stakeholders to implement the obligations under other acts.
The study found that in many instances, information being gathered through REACH is not adequately linked to the relevant sectoral legislation and this could lead to missed opportunities for cost savings as well as for more comprehensive protection for human health and the environment. It suggests guidelines should be developed to address the issue.
The study identifies synergies between REACH and other EU legislation in addition to the many express in-built mechanisms provided for... Such synergies include the use under REACH of information from risk assessments or risk management measures provided for under other legislation.
The study identified synergies in, amongst other things, the Chemicals control legislation, the Product control legislation, the Waste Framework Directive, the Environmental protection legislation and the Food safety legislation.
Overall the study concludes that REACH’s various in-built mechanisms for avoiding overlap seem to work well and the large number of synergies identified between REACH and the various sector-specific legislative acts demonstrate a high level of coherence.
However, there were some cases of double regulation identified where legislative changes or guidance could lead to greater legal certainty and reduce confusion. In addition, a number of gaps were identified which should be addressed in order to support the aim of REACH to ensure a high level of protection for human health and the environment, as well as the free circulation of substances on the internal market. Stronger links between the information that is being gathered through REACH and the relevant sectoral legislation could create opportunities for cost savings and the protection of human health.
In general the study concludes that, "the various acts analysed in the course of this study mesh well with REACH to form a coherent regulatory structure for assessing and managing risks from the manufacture, placing on the market and use of substances, whether on their own, in mixtures and in articles.”
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