ChemRegs Newsletter – May 2021
EU Chemical Legislation Revisions
In 2019 the European Commission (EC) set out a European Green Deal for the European Union (EU) and its citizens, with the aim of resetting the Commission’s commitment to tackling climate and environmental-related challenges. It set out a roadmap for a toxic-free environment leading to zero pollution.
The Chemicals Strategy for Sustainability (adopted on 14 October 2020) is the first delivery of the zero-pollution ambition. The objectives of the Chemicals Strategy for Sustainability are to better protect citizens and the environment against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives.
To this end the Strategy outlined a number of actions intended to increase the knowledge base and control of chemicals.
Although the UK is no longer a member of the EU, it is still advisable to follow developments and proposals in chemical legislation and management.
The EU REACH Regulation on Registration, Evaluation, Authorisation and Restriction of chemicals, together with the EU CLP Regulation on Classification, Labelling and Packaging of chemicals, are the key EU legislation for the assessment and management of chemicals.
The REACH Regulation was last evaluated in 2018 and concluded that REACH is effective, but that there are opportunities for further improvement, simplification and burden reduction. Following the evaluation, a number of non-legislative actions have been launched (some of them finalised, others still ongoing) to improve the implementation of REACH.
In addition, to deliver on the commitments made in the Chemicals Strategy, the CLP Regulation will also be subject to a targeted revision, along other sectoral chemical legislation.
Therefore, the EC has published two Inception Impact Assessments (IIAs), ‘Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals’ and ‘Revision of EU legislation on hazard classification, labelling and packaging of chemicals’.
Inception Impact Assessments aim to inform citizens and stakeholders about the EC’s plans in order to allow them to provide feedback on the intended initiative and to participate in future consultation activities. As the UK is no longer a member of the EU, UK citizens cannot participate in the IIA.
IIA on REACH
An initial list of possible options to revise the REACH Regulation to fill gaps and to simplify and strengthen the legal provisions has been identified.
- Revision of the registration requirements: Various options for revising the registration requirements for manufacturers and importers will be analysed, including increased information on hazards of concern, documentation of safe use, registration of certain polymers, and information on the environmental footprint.
- Introduction of a Mixtures Assessment Factor (MAF): Options for addressing the risks of exposure to several substances (combination effects) by introducing MAFs in Annex I will be analysed.
- Simplifying communication in the supply chains: Options for improving safety data sheets (SDS) will be assessed, including in particular harmonised electronic formats.
- Revision of the provisions for dossier and substance evaluation: Various options will be considered for ensuring that registration dossiers are in compliance and that sufficient information for concluding on concerns is available. These include the possibility to revoke registration numbers for non-compliant registrations and to allow authorities to commission tests to obtain hazard information.
- Reforming the authorisation process: Options include clarifications and simplifications of the current provisions, national authorisation for smaller applications, removing the authorisation title from REACH, integrating the REACH authorisation and restriction systems into one and improving the interface with other pieces of legislation.
- Reforming the restriction process: Options include extending the generic risk approach to restrictions to endocrine disruptors, PBT/vPvB substances, immunotoxicants, neurotoxicants, respiratory sensitisers and substances that affect specific organs; extending the generic risk approach to products marketed for professional use; and operationalising the concept of essential use in restrictions, including the criteria for granting derogations.
- Revision of provisions for control and enforcement: Options include establishing minimum requirements for national controls and enforcement, including stricter border controls; and establishing a European Audit Capacity to audit Member States enforcement.
An impact assessment will be carried out with the objective to identify and assess, both quantitatively and qualitatively, the economic, social and environmental impacts (positive and negative) of the various options. The impact assessment will be finalised and presented together with the Commission’s proposal for revision of REACH by the end of 2022.
IIA on CLP
The impact assessment will consider a range of non-regulatory and regulatory measures compared to a baseline scenario. It will also consider impacts stemming from the current existing sectorial provisions directly affected by the new hazard classes, such as endocrine disruptors in Biocides and Plant Protection Products Regulation.
The Baseline Scenario will take account of the rules and processes in place end of 2020, and under the assumption that the CLP regulation will be implemented as it stands.
The non-regulatory measures, in addition to the current implementation of the CLP regulation, will be considered, amongst which additional guidance and support measures, such as clarifications, technical assistance, training and financing more proposals for harmonised classification.
The measures that will be examined through options with different ambition levels could include, for example:
- Introduce new hazard classes (such as endocrine disruptors).
- Introduce an obligation to provide information of some hazards on the label for products currently outside the scope of CLP.
- Clarify the obligations to classify mixtures and some complex substances.
- Introduce specific rules for online sales.
- Introduce the possibility to submit proposals for and set harmonised environmental and safety values for some substances.
- Require importers and downstream users to submit information on substances classified for physical effects or health hazards to poison centres and clarify obligations for distributors to submit such information, through an only representative or other means.
- Introduce a mandate for Commission to request ECHA to develop new harmonised classification and labelling (‘CLH’) dossiers.
- Allow multilingual fold-out labels.
- Introduce tailored labelling rules where there is not enough space on packaging.
- Introduce a prioritisation mechanism for harmonising the classification of certain chemicals.
An impact assessment will be carried out from May until December 2021. The objective is to identify and assess, which effects the various options are expected to have in terms of improved protection of human health and the environment, as well as the economic costs, the impact on the internal market and social impacts.
As well as these Inception Impact Assessments it is understood that the EU is likely to be shortly releasing an Inception Impact Assessment concerning the EU Cosmetics Regulation.
Other News
Control of Asbestos at Work Regulations 2012 (CAR12)
HSE launched a stakeholder survey on 21 May to consult about the Control of Asbestos Regulations 2012 (CAR12).
This consultation is part of a second post-implementation review (PIR) of the regulations, following the first PIR published in 2017.
The PIR will seek to establish if the regulations continue to meet their objectives, remain appropriate and are still the best means to minimise exposure to asbestos. It is required by regulation 35 of the Control of Asbestos Regulations 2012. The purpose of a PIR is to evaluate the existing regulatory framework, rather than to examine government policy regarding asbestos.
HSE is inviting comments via the survey as they want stakeholders to make a positive contribution to the ongoing regulation of asbestos. Therefore, if asbestos is relevant to you or your business, please take part if you can.
Information from the survey is being collected for internal HSE use only and will not be provided to third parties. It will be stored securely and deleted upon publication of the final CAR12 PIR report.
All individual responses to the survey will be aggregated together and treated anonymously. None of the information provided will be used for regulatory inspection purposes.
The survey will run for three weeks, closing on Friday 11 June, and in most cases will take just 10 to 15 minutes to complete. It is available online:
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk