Europe Regulatory News

On 31 March 2023 the European Commission adopted a Delegated Act amending the Regulation on Classification, Labelling and Packaging of Chemicals (CLP). The revision of CLP, together with the planned r...

On 31 March 2023 the European Commission adopted a Delegated Act amending the Regulation on Classification, Labelling and Packaging of Chemicals (CLP). The revision of CLP, together with the planned revision of REACH is an important part of the European Commissions Chemicals Strategy for Sustainability (CSS) and the European Green Deal. The Regulation entered into force on 20 April 2023.

The Delegated Act amends Annex I of the CLP Regulation and divides the hazard class for endocrine disrupting chemicals (EDCs) into two categories:

• Category 1: Known or presumed endocrine disruptors for human health/the environment

• Category 2: Suspected endocrine disruptors for human health/the environment

Furthermore, hazard classes for the following properties are introduced:

• Persistent, Bioaccumulative, and Toxic (PBT)

• Very Persistent and very bioaccumulative (vPvB)

• Persistent, Mobile, and Toxic (PMT)

• Very Persistent, very Mobile (vPvM)

Substances must be labelled in accordance with the amended Regulation from 1 May 2025. However, substances which were placed on the market before 1 May 2025 compliant labelling is not required until 1 November 2026. For mixtures the corresponding dates are 1 May 2026 and 1 May 2028.

The complete text of the adopted Delegated Act can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0707&from=EN

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.