Europe Regulatory News

On 5 August 2021, the Commission Regulation (EU) 2021/1297 was released to restrict the use of perfluorocarboxylic acids (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related compounds under entry 68 o...

On 5 August 2021, the Commission Regulation (EU) 2021/1297 was released to restrict the use of perfluorocarboxylic acids (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related compounds under entry 68 of REACH Regulation (EC) No. 1907/2006 Annex XVII.   

Starting on 25 February 2023, there is an EU-wide update for restriction on perfluorocarboxylic acids (PFCAs) with a chain of 9 to 14 carbon atoms, as well as their salts and related compounds.  . Some uses have been granted longer transition periods.  

The restriction will take effect on 4 July 2023, and it will apply to PFCAs used in the production of specific products such as polyvinylidene fluoride (PVDF) and polytetrafluoroethylene (PTFE), as well as textiles that are oil- and water-resistant to protect workers from hazardous liquids that could endanger their health and safety. 

From 4 July 2025 onwards the restriction will apply to substances used in invasive and implantable medical devices, photolithography or etch processes in semiconductor manufacturing, photographic coatings applied to films, and firefighting foam for liquid fuel vapour suppression and liquid fuel fire. 

Fluoropolymer and fluoroelastomer manufacture, as well as the production of PTFE micropowders, are all permissible under exemptions granted by the European Commission. 

For the total of C9-C14 PFCAs in fluoroplastics and fluoroelastomers containing perfluoroalkoxy groups, the concentration limit will be 2,000 parts per billion (ppb) up until 26 August 2024. However, this limit will thereafter be lowered to 100 ppb. Also, the Commission has established a limit of 1,000 ppb for the total amount of C9-C14 PFCAs, their salts, and associated compounds when present in PTFE micro particles. Both exemptions will be evaluated by 26 August 2024. 

Per- and polyfluoroalkyl substances (PFASs) include PFCAs as a subset. The much-awaited ECHA proposal to set limits on more than 10,000 PFASs was released last month. 

On 22 March 2023 the European Chemical Industry Council (Cefic) and 30 other associations representing market sectors in the European plastics value chain published a joint letter to the European Comm...

On 22 March 2023 the European Chemical Industry Council (Cefic) and 30 other associations representing market sectors in the European plastics value chain published a joint letter to the European Commission. In the letter they call on the European Commission and Member States to adopt EU harmonized calculating rules for recycled content, by means of mass balance credit method with a fuel-use exempt model, in 2023. The Single Use Plastics Directive (SUPD) Implementing Act should be used as legal foundation.

The mass balance chain of custody tracks specific characteristics and guarantees that the chemically recycled monomers and basic polymers are correctly certified. This methodology is already used in other sectors where sustainable materials are included in a mixed production process such as fair-trade cocoa and chocolate.

In order to reach the EU’s 2050 climate and circularity targets the chemical recycling infrastructure needs investments. The Plastic industry needs legal certainty on the mass balance chain of custody in order to make the necessary investments in the recycling infrastructure.

On 20 April 2023 the European Chemicals Agency (ECHA) published details about application dates and other information related to the new CLP Hazard Classes that came into force on that same date. T...

On 20 April 2023 the European Chemicals Agency (ECHA) published details about application dates and other information related to the new CLP Hazard Classes that came into force on that same date.

The European Commission published a Delegated Regulation on 31 March 2023, setting out new hazard classes and criteria for the Classification, Labelling and Packaging of substances and mixtures (CLP). The Delegated Regulation applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products. It is binding to manufacturers, importers, downstream users, and distributors placing substances on the EU market.

The new hazard classes, their hazard statements, and hazard statement codes are as follows:

The new rules came into force on 20 April 2023 but there are transitional periods during which manufacturers, importers, downstream users, and distributors are not yet required to classify their substances or mixtures according to the new hazard classes. It is however possible to apply the new hazard classes on a voluntary basis. The transitional periods vary from 18 to 24 months for new/existing substances/mixtures. The deadlines can be seen below.

The guidance on applying the CLP criteria is expected to be updates in 2024. Until then companies and Member State Authorities can use the current guidance on identifying endocrine disruptors and assessing PBTs. The new hazard classes will be included in the IT tool IUCLID during spring 2024. After that companies can incorporate information related to the new hazard classes in their classification and labelling notifications, REACH registrations and dossiers for product and process orientated research and development (PPORD), as well as in their submissions under the Biocidal Products Regulation and poison centre notifications.

New substances must comply with the new Regulation from 1 May 2025, whereas substances which were placed on the EU market before 1 May 2025 compliant labelling is not required until 1 November 2026. For mixtures separate transition times apply. New mixtures must comply by 1 May 2026. For mixtures placed on the EU market before 1 May 20261 the deadline for compliance is 1 May 2028.

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

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.