Europe Regulatory News

On 10 July 2023, the European Commission adopted a new regulation on sustainable management of batteries and waste batteries. The regulation will apply to all batteries including all waste portable ...

On 10 July 2023, the European Commission adopted a new regulation on sustainable management of batteries and waste batteries. The regulation will apply to all batteries including all waste portable batteries, electric vehicle batteries, industrial batteries, starting, lightning, and ignition (SLI) batteries (used mostly for vehicles and machinery), and batteries for light means of transport (e.g., electric bikes, e-mopeds, e-scooters). 

The new regulation is designed to promote fair competition and enhance the efficiency of the internal market for batteries. 

 Performance, durability, and safety standards, strict restrictions for dangerous chemicals like mercury, cadmium, and lead, as well as required disclosure of the carbon footprint of batteries all contribute to achieving this. The regulation adds labelling and information requirements, including those for an electronic "battery passport" and a QR code, as well as information on the battery's components and recycled content. Labelling rules will be in effect by 2026 and the QR code by 2027, providing member states and market participants time to be ready. 

The regulation seeks to minimize any negative effects on the environment and society during the battery's entire life. To do this, the regulation sets strict due diligence requirements for operators who must confirm the origin of the raw materials used in the batteries they sell. The regulation allows SMEs to be excluded from the requirements for due diligence. 

The regulation on batteries targets every phase of the life cycle of batteries, from design to waste treatment, with the goal of establishing a circular economy for the battery industry. This endeavour is quite significant, especially considering the rapid advancement of electric mobility. By 2030, the need for batteries is anticipated to have multiplied more than ten-fold. The new rule will complete the law and replace the present batteries directive from 2006, notably with respect to waste management. 

By regulating batteries throughout their life cycle, the new regulations seek to advance a circular economy. Consequently, the rule establishes end-of-life criteria, such as collection responsibilities, goals for material recovery, and expanded producer accountability.  

The regulation sets the below targets: 

The adoption process was concluded by the Council’s vote. The Council and European Parliament will now ratify the regulation. Then, it will likely go into effect on 30 July 2023 after being published in the Official Journal of the EU. 

The full text of the regulation can be found here. 

On 26 June 2023, a proposed exemption for the use of cadmium and lead in polyvinyl chloride (PVC) under Annex IV of the EU Directive on the restriction of hazardous substances (RoHS) in electrical and...

On 26 June 2023, a proposed exemption for the use of cadmium and lead in polyvinyl chloride (PVC) under Annex IV of the EU Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment was put out for discussion by the European Commission. The draft delegated directive's consultation period began on 27 June and will expire on 25 July. 

The proposed  

exemption would be for the use of cadmium and lead in plastic profiles in electrical and electronic windows and doors containing recovered PVC. In polyvinyl chloride (PVC), lead and cadmium are employed as thermal stabilisers. Such uses were covered by the prior exception 41 in Annex IV of the RoHS Directive. 

Cadmium is restricted by entry 23 of Annex XVII to the REACH Regulation. The restriction does not apply to articles containing recovered PVC if their concentration of cadmium does not exceed 0,1% by weight of the plastic material in articles, including doors and windows. Lead is restricted by entry 63 of Annex XVII to the REACH Regulation and shall not be placed on the market or used in articles produced from polymers or copolymers of PVC, if the concentration of lead is equal to or greater than 0,1 % by weight of the PVC material. 

The technical and scientific evaluation of the proposed exemption concluded that:  

• Cadmium and lead are used in PVC frame material for windows and door sets for the purpose of polymer stabilisation of the PVC profiles. 

• Most of the applications for window and door sets are not electrical. Only a small amount compared to all windows and doors requires a time-limited exemption as they are EEE according to Article 3(1) of the RoHS Directive. 

• While lead- and cadmium-free technologies used in virgin PVC are available on the market, use of recovered PVC requires lower amounts of energy and natural resources (such as water, petroleum and natural salt) than would be otherwise needed for use of virgin PVC. The use of recovered PVC is thus associated with socio- economic benefits in particular with regard to decarbonisation, circular economy and raw material availability. 

The proposed exemption therefore complies with Article 5 (1) (a) of the RoHS Directive: the total negative environmental impact, health impact, and consumer safety impact that may arise through substitution may exceed the overall environmental impact, health impact, and consumer safety benefits it generates. Therefore, the recycling and use of PVC containing lead and cadmium is related to socio-economic benefits and helps to reduce carbon emissions and promote a circular economy. 

The exemption is requested for 5 years which is the maximum validity period according to Article 5(2) of the RoHS Directive. 

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.