ChemRegs Newsletter – July 2023

UK REACH

The law for UK REACH has been revised so that changes can be made to the statutory deadlines for UK REACH transitional registrations

A statutory instrument (SI) for extending the UK REACH submission deadlines has been passed by Parliament and entered into force on Wednesday 19 July 2023. The REACH (Amendment) Regulations 2023 (SI 2023/722) gives effect to these changes and can be found on legislation.gov.uk.

This will extend the current statutory deadlines for transitional registrations by 3 years to 27 October 2026, 27 October 2028 and 27 October 2030 depending on tonnage and toxicity.

EU biocides review programme extended

At the 100th meeting of the EU Members States Competent Authorities (CA) for EU Biocidal Products in June 2023, discussions continued on the need for an extension of the period allocated to complete the Review Programme of active substances in biocidal products.

The Review Programme is the name for the work programme for the examination of existing biocidal active substances contained in biocidal products. The programme was set up by the European Commission under the EU Biocidal Products Directive (BPD) and continues under the EU Biocidal Products Regulation (BPR).

Active substances in biocidal products are divided into two categories: new substances and existing substances. Existing active substances are those substances which were on the market on 14 May 2000 as an active substance of a biocidal product (for purposes other than scientific or product and process-orientated research and development), while new active substances are those introduced after that date.

Active substances used in biocidal products must be approved within the EU before they can be put on the market. Before an active substance can be approved, it must be evaluated with respect to effectiveness and impact on human health and the environment. Then, after active substances have been approved, biocidal products containing the substances must also be authorised. Active substances that are classified as existing active substances are evaluated through the EU Review Programme. They may be used in biocidal products of a specified product type, in accordance with current national rules and practice, for as long as the evaluation is in progress.

New active substances also must go a review and may only be made available on the EU market before the substance has been approved if the biocidal product has been granted temporary national authorisation in accordance with Article 55(2) of the EU Biocidal Regulation.

The current date for completion of the review is 2024. At the recent CA meeting EU Member States proposed a range from 3 to 6 years of extension, with several Member States noting that a minimum of 5 years would be necessary. It was also remarked that, due to some recent taking over of active substances, some applications may still be submitted 2 years after acceptance of the notification, and would therefore need time to be processed. One Member State remarked that 45% of the work was done in around 20 years, and questioned whether even 10 years would be sufficient. However, it was agreed that the European Commission would propose to extend the duration of the review programme until 31 December 2030.

At the moment, there are no plans to postpone the review programme to an even later date, given that most applications were submitted in 2004-2008. Furthermore, the Commission intends to conduct a REFIT evaluation of the current Regulation to be concluded in 2026 – any potential changes resulting from the evaluation should be in place by the end of 2030.

It was also determined that the extension of the period cannot, alone, ensure the completion of the review programme. Further actions were considered to be necessary, and some may need to be “drastic” to limit further delays and finally conclude the review programme. One action proposed was that the current “taking-over mechanism” i.e the provisions for taking over the role of participant be removed for the new Review Regulation.

The European Commission will start preparing a modification of the Review Regulation in this respect.

The GB Review Programme is the system of evaluating existing biocidal active substances in Great Britain (England, Scotland and Wales). This is based on the EU system.

A list of active substances that are being or have been evaluated as part of the GB Review Programme can be found on the GB List of Active Substances by filtering the Regulatory process column and selecting Review Programme for existing active substances.

The rules and procedures of the GB Review Programme are provided by the GB Review Regulation. To gain authorisation to place a biocidal product on the market in Great Britain (GB) under the GB Biocidal Products Regulation (GB BPR) the active substance(s) in the product must first be approved for the relevant product type(s) and included on the GB List of Active Substances or the GB Simplified Active Substances List.

The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 came into force 31st December 2022 and extended the timeframe for the GB Review Programme until 31 December 2027.

Proposal to restrict the manufacture and use of PFAS

The Dangerous Goods Unit of the Department for Transport (DfT) are trying to raise awareness of a proposal to restrict the manufacture and use of PFAS. The details of a proposed restriction of around 10 000 per- and polyfluoroalkyl substances (PFASs) have been published on the ECHA website.

PFASs – effectively “forever chemicals” are being phased out by the EU because, without restrictions, they are deemed to have negative effects on people’s health and the environment. (See also our April Newsletter).

It has been estimated that around 4.4 million tonnes of PFASs could end up in the environment over the next 30 years unless action is taken.

More importantly for the Dangerous Goods sector, PFASs are used in the manufacture of components such as seals which, if they should no longer be available, will mean that components manufactured from alternative materials will need to be sourced. It is possible that in some cases suitable alternatives may not be available and this may therefore have a significant impact on the sector.

The DfT has attempted to raise awareness of the proposed restriction at recent stakeholder meetings and, given the potential industry issues that a complete ban would raise, have encouraged delegates to respond to the consultation and further raise awareness.

It is hoped that larger bodies within the industry and trade associations have responded to the consultation on behalf of their sector and that this will influence the consultation outcomes. However, it is also understood that some DfT stakeholders with a direct interest in this restriction may be unaware of this issue and its potential impact to the transport of dangerous goods. With this in mind the DfT are now looking to further raise awareness of the consultation and encourage them to also respond.

Link to ECHA Proposal – All news – ECHA (europa.eu)

Link to media briefing video – Media briefing: proposal to restrict PFAS chemicals in the EU

ANNEX XV RESTRICTION – Report proposal for a restriction – Annex XV reporting format 040615 (europa.eu)

The six-month consultation started on 22 March 2023 and closes on 25 September 2023 at 23:59 Helsinki time (EET) and a link to consultation is available here: Submitted restrictions under consideration.

It is important for those with an interest to respond to the consultation and raise any concerns they have regarding PFAS used in the transport of dangerous goods and for which there are no non-PFAS alternatives. Before responding, please read the Consultation Guidance and the Information Note, as they explain both the process and the proposal itself.

For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk