Europe Regulatory News

On 22 June 2023, the European Chemistry Agency (ECHA) announced that its Committee for Socio-Economic Analysis (SEAC) supports the gradual ban on per- and polyfluoroalkyl substances (PFASs) in firefig...

On 22 June 2023, the European Chemistry Agency (ECHA) announced that its Committee for Socio-Economic Analysis (SEAC) supports the gradual ban on per- and polyfluoroalkyl substances (PFASs) in firefighting foams proposed by ECHA in February 2022. The restriction could reduce the emission of PFAS into the environment by approximately 13 200 tonnes over a period of 30 years.

The REACH Annex XV restriction dossier for an EU-wide restriction on all PFASs in firefighting foams was proposed by ECHA on 27 February 2022. The aim of the restriction is to prevent further contamination of groundwater and soil as well as health risks for humans and the environment. All PFASs, or their breakdown products, are very persistent and some are known to harm human health or the environment. The combination of persistence and the potential to cause harm means that it is important to minimise further releases of these substances to reduce the likelihood of, potentially irreversible, harm in the future.

The restriction dossier sets a concentration threshold of 1 ppm for remaining PFAS-contamination in firefighting foam systems. Furthermore, the dossier gives sector-specific transition periods that allow time to replace PFAS-containing foams without compromising fire safety.

On 23 March 2023 ECHA’s Committee for Risk Assessment (RAC) published their support of the restriction dossier. The RAC concluded that there is an EU-wide risk for humans and the environment from the use of PFASs in firefighting foams since 470 tonnes of PFAS is released into the environment each year. The RAC stated that the proposed restriction would effectively reduce emissions and the associated risks posed by these persistent substances.

In its opinion published on 22 June the SEAC considers that the proposed restriction on the placing on the market, use and formulation of PFAS in firefighting foams is the most appropriate EU-wide measure to address the identified risks. These conclusions follow the opinion of the RAC mentioned above. However, the SEAC suggests:

• that a review of available fluorine-free alternatives for sites that produce, treat or store dangerous substances (covered by the Seveso Directive) and those neighbouring them is carried out before the end of the 10-year transition period.

• that a review is needed for uses at offshore installations in the oil and gas industry, where SEAC is recommending lengthening the transition period from five to 10 years. The committee considers the reviews important to maintain safety where fires may have high impacts on the environment and human health.

• that the transition periods for uses in civilian shipping are lengthened from three to five years and the transition period for placing certain types of portable fire extinguishers on the market from lengthened from 6 to 18 months. This is to ensure that technically suitable fluorine-free alternatives are available when the transition periods end.

The next step for the PFAS restriction dossier requires that ECHA combines the opinions of RAC and SEAC into one for publication and submits the opinion and the restriction proposal to the European Commission. The Commission will then decide whether a restriction is necessary. If that is the case the Commission will make a proposal to amend the list of restrictions of the REACH regulation (Annex XVII). The proposal will be voted on by the EU Member States in the REACH Committee and scrutinised by the European Parliament and Council before adoption into law.

On 26 June 2023, the European Chemicals Agency (ECHA) started a targeted public consultation on the harmonised classification and labelling of metyltetraprole (ISO); 1-[2-({[1-(4-chlorophenyl)-1H-pyra...

On 26 June 2023, the European Chemicals Agency (ECHA) started a targeted public consultation on the harmonised classification and labelling of metyltetraprole (ISO); 1-[2-({[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy}methyl)-3-methylphenyl]-4-methyl-1,4-dihydro-5H-tetrazol-5-one. The deadline for commenting the consultation is 10 July 2023.

The reason for this extra consultation for metyltetraprole (ISO) is that ECHA received eight documents containing additional information on carcinogenicity after the first consultation ended on 10 March 2023. Comments can be submitted here. EHCA’s Committee for Risk Assessment will take the new info into account when developing its opinion.

On 8 June 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published preliminary opinions on the use of methylparaben and butylparaben in cosmetics. The European Commission has opened p...

On 8 June 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published preliminary opinions on the use of methylparaben and butylparaben in cosmetics. The European Commission has opened public consultation on the 2 preliminary opinions and the deadline for comments is 21 August 2023.

Methylparaben and butylparaben have been assessed to rule out potential endocrine-disrupting properties and to ensure their safe use in cosmetics. The EU’s Cosmetics Regulation (Regulation (EC) No 1223/2009) does not have explicit provisions for the management of endocrine disruptors (EDs) therefore the European Commission requested the SCCS to conduct safety assessments on the two substances.

The conclusion of the SCCS in the two preliminary opinions was that methylparaben and butylparaben are safe for use as preservatives in cosmetics when used as summarized in the following table.

According to the SCCS, methylparaben and its salts are widely used in cosmetics, food products, and pharmaceutical formulations. In cosmetics it is the one used most frequently. It is either used alone ore in combination with other parabens or other antimicrobial agents. Butylparaben has been widely used as a preservative in cosmetics and pharmaceutical preparations for 70 years.

The preliminary opinion for methylparaben can be found here and the one for butylparaben can be found here.

The European Chemical Agency (ECHA) recently organized a workshop on New Approach Methodologies (NAMs) with over 500 participants to discuss ways to replace animal testing in the hazard assessment of ...

The European Chemical Agency (ECHA) recently organized a workshop on New Approach Methodologies (NAMs) with over 500 participants to discuss ways to replace animal testing in the hazard assessment of industrial chemicals while at the same time ensuring a high level of protection of human health and the environment.

The workshop aimed to achieve a common understanding of what short and long-time goals can be realized with NAMs. Some issues discussed at the workshop were:

• Potential areas where NAMs could be used to reduce regulatory dependence on data generated with animal tests.

• How to accelerate the regulatory acceptance of NAMs.

• The potential of NAMs to accelerate the pace of assessment while taking ethical values into consideration.

The concluding remarks from the Director for Prioritisation and Integration, Ofelia Bercaru, indicated that ECHA opens the way for animal testing-free chemicals regulation in the future: “ECHA is committed to supporting the development of new methodologies to replace testing on animals. We also want to contribute to future EU chemicals regulation which would not rely on animal testing. This workshop gave us new views and a better understanding on how we can move forward, while implementing horizonal regulations such as REACH and CLP." 

Prior to the workshop ECHA published its fifth report on the use of alternatives to testing on animals for the REACH Regulation. The report finds that progress is being made in the increased use of alternatives to gather data on the properties of substances, in place of animal testing. An example is that there has been a significant increase in the use of in vitro test methods. These are methods that involve studies with cell, tissues, or organs which are used to obtain data for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation. Approximately 50% of the studies conducted for skin and eye irritation in the period 1990-2022 were performed in vitro. For new studies conducted in 2019-2022, this percentage rises to approximately 90%.

The report reveals opportunities and challenges associated with moving away from animal testing in the regulatory assessment of chemicals. Additionally, it presents the initiatives made by ECHA to promote non-animal testing and to increase the acceptance and uptake of NAMs.

On 8 June 2023 the European Commission added 24 new entries for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) to the REACH Restricted Substance List (Annex XVII). The lis...

On 8 June 2023 the European Commission added 24 new entries for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) to the REACH Restricted Substance List (Annex XVII). The list of substances was published in an Annex to the Commission Regulation 2023/1132 in the Official Journal of the European Union on 9 June. The Commission Regulation can be found here. The restrictions will come into force on 1 December 2023.

The 24 new substances are classified as Category 1A and 1B CMR substances. Category 1A contains chemical substance for which there is scientific evidence based on humans that the substance is CMR. For Category 1B the scientific evidence is based on animals. Under the REACH regulation substances that are categorised as CMR 1A and 1B cannot be placed on the market or used.

The substances added to Annex XVII include the following:

Furthermore, five existing substance entries in Annex XVII have been amended.

On 14 June 2023, the European Chemicals Agency (ECHA) added two chemicals to the Candidate list of Substances of Very High Concern (SVHC). SVHCs are substances that can have serious and often irrev...

On 14 June 2023, the European Chemicals Agency (ECHA) added two chemicals to the Candidate list of Substances of Very High Concern (SVHC).

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. With the new additions the Candidate list now has 235 entries, some are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use.

The first new substance is diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO) which is identified as toxic to reproduction in accordance with Article 57(c) of the REACH Regulation. TPO is primarily used in inks and toners but also in a wide range of products such as photo-chemicals, adhesives, sealants, and polymers. Between 10,000 and 100,000 tonnes are manufactured or imported in the European Economic Area (EEA) every year.

The second new substance is bis(4-chlorophenyl) sulphone (BCPS) which is a very Persistent and very Bio-accumulative (vPVB) substance according to Article 57(e) of the REACH Regulation. BCPS is used industrially to produce polymers, rubbers, and other chemicals. It is manufactured and imported in the EEA in the range of 10,000 to 100,000 tonnes per year.

Under REACH there are legal obligations when it comes to substances in the Candidate List:

• Suppliers must give their customers and consumers information if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs. Suppliers of substances on the Candidate List, either on their own or in mixtures, have to provide a Safety Data Sheet to their customers.

• Importers and producers of articles that contain a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

Furthermore, under the Waste Framework Directive, companies have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 % (weight by weight).

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) ar...

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) are revised and updates by the European Commission’s Scientific Committee on Consumer Safety (SCCS) approximately every 3 years, to incorporate the progress in the field of testing and safety evaluation of cosmetic ingredients. The NoG aim to provide guidance to public authorities and the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation (Regulation (EC) No. 1223/2009). The notes contain information on the different aspects of testing and safety evaluation of cosmetic substances with the emphasis on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products.

The updates in the 12th revision of the Notes of Guidance have emphasis on the following aspects:

• Importance of systematic literature review

• Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus)

• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA (Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC)

• Updating of in silico prediction possibilities

• Exposure data reviewed (models, parameters specific for inhalation, aggregate exposure)

• Exposure of children to different cosmetic product categories according to age

• Sun protection by sunscreen products: rationale behind exposure data

• Human biomonitoring (HBM) and differences with SCCS approach for risk assessment

• Reporting requirements for cancerogenic, mutagenic and reprotoxic substances (CMRs)

• Introduction of non-monotonic dose response, reporting requirements for endocrine active substances

• Templates for PBTK (Physiologically Based ToxicoKinetic) model description and parameter verification and analysis

The full text of the NoG can be found here: https://health.ec.europa.eu/system/files/2023-05/sccs_o_273.pdf