Europe Regulatory News

On 12 April 2023 ECHA recommended that the European Commission adds eight substances (including lead metal) from the Candidate List of Substances of Very High Concern (SVHC) to the Authorisation List ...

On 12 April 2023 ECHA recommended that the European Commission adds eight substances (including lead metal) from the Candidate List of Substances of Very High Concern (SVHC) to the Authorisation List (Annex XIV of REACH).

The recommendation includes the following six chemicals that are toxic to reproduction:

• 2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers

• Lead

• 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one

• 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone

• Diisohexyl phthalate

• Orthoboric acid, sodium salt

Furthermore, the following two chemicals that are respiratory sensitisers are also recommended:

• Ethylenediamine

• Glutaral

It is now up to the European Commission to decide which substances will be included in the Authorisation list and what conditions will apply for each substance. Once a substance is included in the Authorisation List, it cannot be placed on the EEA market or used after a specific date without having an authorisation granted for a specific use. The aim of the authorisation process is to encourage the substitution of SVHCs with safer alternatives.

On 15 March 2023 the European Chemicals Agency (ECHA) announced its Regulatory Strategy for Flame Retardants which points out aromatic brominated flame retardants as candidates for an EU-wide restrict...

On 15 March 2023 the European Chemicals Agency (ECHA) announced its Regulatory Strategy for Flame Retardants which points out aromatic brominated flame retardants as candidates for an EU-wide restriction. The Regulatory Strategy is part of the European Commission’s Restrictions Roadmap published in 2022. The roadmap is a rolling list containing large quantities of harmful chemicals which are to be prioritized for bans under the EU Chemicals Strategy for Sustainability.

• All aromatic brominated flame retardants that are or will be classified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) through harmonised classification or identification as substances of very high concern (SVHCs) could be covered by the scope of the restriction. This group includes polybrominated diphenyl ethers (PBDEs) known to be persistent in the environment and substances such as decabromodiphenylether (decaBDE) which is suspected of being toxic and accumulating in people and animals.
• Aliphatic brominated and some organophosphorous flame retardants (OPFRs) will be studied further to determine if restriction is necessary. ECHA suggests reassessing those groups in 2025 when more data will be available.
• Non-halogenated subgroups of flame retardants and some OPFRs are presently outside the scope of regulatory actions since no or low hazard was identified for these substances at this time. For chlorinated flame retardants regulations are already or have been initiated.
• Halogenated (including brominated) flame retardants and OPFRs account for 70 % of the organic flame retardant on the market.
• Other flame retardants will be assessed in future Assessments of Regulatory Needs (ARNs).

The European Chemicals Agency (ECHA) is calling for scientific and technical information on the use, manufacture, and placing on the market of per- and polyfluoroalkyl substances (PFAS). The informati...

The European Chemicals Agency (ECHA) is calling for scientific and technical information on the use, manufacture, and placing on the market of per- and polyfluoroalkyl substances (PFAS). The information will be used to evaluate a restriction proposal prepared by the Danish, German, Dutch, Norwegian, and Swedish authorities. The consultation period will last for six months, starting from March 22, 2023, and ending on September 25, 2023. Interested parties can submit information relevant to PFAS risks, socio-economic aspects, and alternative substances. ECHA's Risk Assessment and Socio-Economic Analysis scientific committees will review the input and form an opinion on the proposed restriction.

The national authorities of Sweden, Denmark, Norway, the Netherlands and Germany submitted a proposal to restrict PFAS to ECHA on 13 January. The European Commission, together with the EU Member States is in the reviewing process of the potential restriction based on the proposal and the committees’ opinion.

On 27 February 2023 the European Commission adopted a new proposal on the voluntary digital labeling of EU fertilising products. Digital labeling has already been adopted by the EU and is being used o...

On 27 February 2023 the European Commission adopted a new proposal on the voluntary digital labeling of EU fertilising products. Digital labeling has already been adopted by the EU and is being used on certain products which contain chemical substances. Based on this proposal, suppliers of fertilisers whose products meet EU health, safety, and environmental standards would be allowed to provide information on a digital label.

It is believed that this proposal could help users of fertilising products understand and use the products more safely and efficiently. Moreover, it would reduce the costs for the suppliers from €57,000 annually for a large company and €4,500 for an SME.

It should be noted that based in this proposal the fertilising suppliers are given the choice to choose which format of labelling they wish to use, meaning that the suppliers and retailer have the choice between the physical and digital format or a combination of the two.

This proposal has been sent to the European Parliament and the Council and in case of adoption, there would be a two- and half-year transaction period. This period would allow for more detailed technical rules to be decided.

ECHA, the European Chemicals Agency, has updated its guidance for importers and manufacturers of polymers and monomers to comply with minimum requirements for REACH (Registration, Evaluation, Authoriz...

ECHA, the European Chemicals Agency, has updated its guidance for importers and manufacturers of polymers and monomers to comply with minimum requirements for REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations. The changes include updated registration obligations for importers and manufacturers. The updated guidance includes changes to the monomer registration requirements, the calculation of registration tonnages, and the information required in chemical safety reports. ECHA is urging all relevant parties to review their REACH registrations to ensure compliance with the updated guidance.

To access ECHA polymer and monomer guide click here: https://echa.europa.eu/-/guidance-for-monomers-and-polymers

The Waste Framework Directive's database (WFD) for information on substances of concern in articles as such or in complex objects (products) is known as Substances of Concern In Products (SCIP). A...

The Waste Framework Directive's database (WFD) for information on substances of concern in articles as such or in complex objects (products) is known as Substances of Concern In Products (SCIP). As of January 5, 2021, businesses who provide goods with Substances of Very High Concern (SVHCs) on the Candidate List in a concentration greater than 0.1% weight by weight (w/w) to the EU market must provide the European Chemicals Agency (ECHA) with information on those products. Over a product's entire lifespan, even when it is in the disposal stage, the SCIP database makes sure that information on items containing chemicals on the Candidate List is accessible. The database's data is subsequently made available to waste management professionals and end users. 

 The German Environment Agency and 20 additional partners from 13 EU member states launched the AskREACH project in 2017. Its objective was to improve supplier and customer understanding of and communication regarding SVHCs. The EU amended the WFD a year later and opted to launch the SCIP database. As it was being developed, ECHA and AskREACH frequently discussed a potential alignment or shared entry format for the two systems. These programs aimed to broaden the dissemination of information regarding SVHCs to garbage operators, consumers, and other supply chain users. n. Since, for instance, SCIP utilises different identities [for chemicals and articles], the alignment of SCIP and the AskREACH consumer app was discovered to be impractical. 

On January 25, 2023, the AskREACH final conference was held in Brussels. High-level speakers  brought up the necessity for Art. 33's implementation and the requirement that products made and sold in Europe be safe for both the environment and consumers. 

The conference also heard repeated requests from NGOs and authorities for the Commission to shorten the period of time that businesses have to respond to requests for information on SVHCs in articles, as required by REACH Article 33. This mandates that anybody selling items that contain more than 0.1% of an SVHC by weight must warn their clients and offer usage tips within 45 days of doing so. 

The obligations and goals of the Article 33. are not being met, according to representatives from business and NGOs. Participants at the conference attributed this to a lack of knowledge about customers' rights and duties among consumers, retailers, and suppliers, as well as consumer challenges with requests and suppliers' poor, incorrect, or non-responsive responses. The AskREACH project has proposed several measures to the Commission to strengthen Article 33, including: requiring businesses to respond to consumer inquiries even when the article contains no SVHCs > 0.1%, or an obligation to always inform consumers; defining who is responsible for providing SVHC information in cases of online trade, for example, by amending REACH's definition of "supplier;" 

Nevertheless, members of the AskREACH initiative reminded the conference that in order for suppliers to properly respond to customers, they must have a working supply chain communication system in accordance with Article 33(1) and be ready for the requests. 

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a p...

The revision of the FCM Regulation has been long-awaited, with the Regulation not having been reviewed since its entry into force in 2004. In May 2020, the Commission announced that it would adopt a proposal for the revision in the fourth quarter of 2022. However, due to the Regulation being “complex” the revision was postponed to 2023.

Recently the Commission's Department on Health & Food Safety (DG Sante) revealed that work on the revision would not begin until 2025. The Commission's numerous proposals announced under the REACH and CLP revisions have added to the challenges, with questions arising over the extent to which these policy options, including essential use criteria, should be factored into the work on updating the FCM Regulation.

Despite the delay in legislative work, DG Sante has outlined plans for 2023 to refine solutions and define more detailed policy options for the revision of the FCM Regulation. The focus will be on policy pillar A: 'shifting the focus onto the final material' and pillar B: 'prioritisation of substances'. Together, these pillars will form the core of the future risk management approach, with new material categories being applied.

The goals for pillar A are for producers of final FCMs to have full knowledge of 'migratables' and to become solely accountable for their release above the permitted safe levels. DG Sante's objective is also for all migratables to be risk assessed by national authorities or potentially businesses, as outlined in pillar B.

Under pillar B, the directorate will also create three tiers. The first is generic rules that will apply to the use of the most hazardous substances. Tier two will see public authorities conducting risk assessments, while the final tier envisages business operators assessing "more benign" chemicals.

In addition to these pillars, DG Sante plans to work on a study to assess the impact and options of pillar C – 'supporting safer and more sustainable alternatives'. The study is expected to be submitted to the Commission's regulatory scrutiny board by Q1 2024.

It has furthermore been pointed out that the drafting of the proposal is likely to clash with the European elections in May 2024 and the appointment of a new college of commissioners six months later. This could further delay the proposal, depending on other priorities such as dealing with the cost-of-living crisis and energy security.

If the proposal comes out in 2025, a revised regulation might not come into place until 2026 or 2027.