Europe Regulatory News

On 26 July 2023, the European Commission published Regulation (EU) 2023/1545 in the Official Journal of the European Union, amending Regulation (EC) No 1223/2009 (the Cosmetics Regulation) concerning...

On 26 July 2023, the European Commission published Regulation (EU) 2023/1545 in the Official Journal of the European Union, amending Regulation (EC) No 1223/2009 (the Cosmetics Regulation) concerning the labelling of fragrance allergens in cosmetic products. The Regulation will come into force on 15 August 2023.

So far 26 fragrance allergens listed in Annex III of the Cosmetics Regulation must be mentioned in the list of ingredients (individual labelling). However, in an opinion published by the Scientific Committee on Consumer Safety (SCCS) in 2012 identified a further 56 additional fragrance ingredients in cosmetic products that clearly caused allergies in humans and that did not have any requirement of individual labelling.

Regulation 2023/1545 introduces new obligations to individually label the 56 additional fragrance allergens listed by the SCCS. These allergens must be labelled individually if their concentration surpasses 0.001% in leave-on products and 0.01% in rinse-off products. The introduction of these new obligations is accomplished by generating new entries in Annex III to Regulation (EC) No 1223/2009. Under the new regulation, there is a strong emphasis on maintaining consistency and clarity. To achieve this, certain existing entries for fragrance allergens in Annex III to Regulation (EC) No 1223/2009 are being updated. The aim is to align the common names of substances with the most recent version of the Common Ingredients Glossary, as referenced in Article 33 of the Regulation. Moreover, similar substances will be grouped together, streamlining the labeling process and minimizing any potential confusion.

The list of affected fragrance allergens can be found here. There will be a transition period of 3 years for adapting product formulations and containers so that only cosmetic products complying with the new requirements are placed on the market. A 5-year transition period is given to withdraw cosmetic products from the market which do not comply with the new requirements and were placed on the market before the new labelling provisions become applicable.

On 14 July 2023, the European Commission adopted a proposal to revise the Mercury Regulation and thereby ban all remaining intentional uses of the metal.  The Commission proposal was adopted in paral...

On 14 July 2023, the European Commission adopted a proposal to revise the Mercury Regulation and thereby ban all remaining intentional uses of the metal.  The Commission proposal was adopted in parallel to a delegated act (Prohibition against the manufacture, import and export of eight additional mercury containing products), aligning the revision with decisions taken by the 4th Conference of Parties (COP4) of the Minamata Convention.

Mercury is a highly toxic chemical which poses significant hazards to both human health and the environment. Upon its release into the ecosystem, enters the food chain, primarily accumulating in fish. Exposure to elevated levels of mercury can lead to detrimental effects on the brain, lungs, kidneys, and the immune system.

The revised Mercury Regulations targets uses of mercury in a number of products in the EU some of which are listed below. These are consistent with the commitments in EU’s Zero Pollution Ambition.

• A total phase-out of the use of dental amalgam will be introduced from 1 January 2025 whereby human exposure and the environmental burden will be reduced.

• Manufacture and export of dental amalgam from the EU will be prohibited from 1 January 2025.

• Manufacture and export of six mercury containing lamps will be prohibited from 1 January 2026 and 1 January 2028 depending on the type of lamps.

The delegated act adopted under the Mercury Regulation incorporates decisions made at COP4 into EU law. It achieves this by introducing a prohibition on the manufacture, import, and export of the eight products containing mercury, including mercury-containing lamps, tire balancers/wheel weights, photographic film and paper, and mercury vacuum pumps.

The Minamata Convention entered into force on 16 August 2017, is the main international legal framework seeking to protect human health and the environment from anthropogenic emissions and releases of mercury to air, water and land. Like the Mercury Regulation, it addresses the whole life cycle of mercury, from primary mercury mining to mercury waste disposal. The convention has been ratified by the EU and 143 countries, including all the EU member states.

The revised Mercury Regulation will now be subject to the approval of the European Parliament and the Council as part of the ordinary legislative procedure. The delegated act is transmitted to the European Parliament and the Council for their scrutiny.

On 14 July 2023, the European Commission adopted an amendment (Commission Regulation (EU) 2023/1464) to the REACH Regulation which introduces maximum emission limit for formaldehyde in a variety of co...

On 14 July 2023, the European Commission adopted an amendment (Commission Regulation (EU) 2023/1464) to the REACH Regulation which introduces maximum emission limit for formaldehyde in a variety of consumer products.

Formaldehyde is mostly used in the production of resins, thermoplastics, and other chemicals. These chemicals are then incorporated in a range of consumer products and applications, such as in the manufacturing of wood-based furniture and flooring, which are the main sources of exposure to formaldehyde emissions in indoor air for consumers. It is also used in textile and leather products, parts for vehicles and aeroplanes, as well as foams, plastic, and synthetic vitreous fibres.

Formaldehyde is classified as carcinogenic (category 1B), mutagenic (category 2) in the European Chemicals Agency’s classification and labelling inventory. Furthermore, it has acute toxicity (category 3), skin corrosive (category 1B) and skin sensitising (category 1) properties.

The following table summarizes the emission limits of formaldehyde into air established by the new rule for various types of products. The limits will ensure a high level of protection for human health and at the same time limit the socio-economic burden as well as the need for technological changes for a wide range of industries and sectors. There will be a 36-month transition period which will give producers of articles where formaldehyde is used sufficient time to implement the restriction requirements, develop relevant analytical methods to test formaldehyde emissions, and start utilizing formaldehyde-free or low emitting formaldehyde products. For vehicles the transition period will be 48 months.

When it comes to wood-based articles and furniture the following articles are exempted:

1. Articles in which formaldehyde or formaldehyde releasing substances are exclusively naturally present in the materials from which the articles are manufactured.

2. Articles exclusively for outdoor use under foreseeable conditions.

3. Articles in constructions, that are exclusively used outside the building shell and vapor barrier and that do not emit formaldehyde into indoor air.

4. Articles exclusively for industrial or professional use unless formaldehyde released from these leads to exposure of the general public under foreseeable conditions of use

5. Articles falling under the scope of entry 72 to Annex XVII of the REACH Regulation

6. Articles that are biocidal products within the scope of Regulation (EU) 528/201.)

7. Medical devices (Regulation (EU) 2017/745)

8. Personal protective equipment within the scope of Regulation (EU) 2016/425.

9. Food contact materials and articles within the scope of Regulation (EU) 1935/2004.

10. Second-hand articles

When it comes to road vehicles the following exemptions apply:

1. Road vehicles exclusively for industrial and professional use, unless the concentration of formaldehyde in the interior of those vehicles leads to exposure of the general public under foreseeable conditions of use.

2. Second-hand vehicles

The regulation emphasizes that toys for children of all ages fall within the scope of restrictions. The limit value for formaldehyde emissions into indoor air therefore applies to toys for children of all ages.

The European Chemicals Agency (ECHA), with the support of industry and experts, will develop guidance to facilitate the harmonised implementation of the test conditions for the measurement of formaldehyde emissions.

The full text of Commission Regulation 2023/1464 can be found here.

On 6 June 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union adopted the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The guidanc...

On 6 June 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union adopted the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The guidance on nanomaterials should be used in conjunction with the general guidance for the submission of safety dossiers of cosmetic ingredients “The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision, SCCS/1647/22” or any future revision.

In the EU, the use of nanomaterials in cosmetics is specifically covered under the Cosmetic Regulation (EC) No 1223/2009, which provides a definition of a nanomaterial (NM) and requires premarket notification, safety evaluation, and labeling of cosmetics containing NM ingredients. If the European Commission has concerns regarding the safety of an NM, the Commission shall refer it to the SCCS for a scientific opinion.

This Guidance is an up-to-date revision of the existing Guidance (SCCS, 2019) and aims to provide an overview of the key issues and data requirements relating to the safety assessment of NMs in cosmetics. The revision contains a number of changes. New sections have been introduced covering aspects such as solubility and dissolution rate, solubility in non-aqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, and endocrine disruption. The European Commission recommendation for a definition of nanomaterials published in 2022 has been incorporated. Key aspects triggering safety concerns over a nanomaterial based on the SCCS’s scientific advice on the safety of nanomaterials in cosmetic (SCCS/1618/2020) have been introduced, providing a clearer understanding of potential risks associated with nanomaterials. Additionally, Annex 1 and other sections of the Guidance have been updated based on recent literature, the section on read-across and grouping has been revised and a text explaining when historical/existing data can be used has been included.

The full text of the revised Guidance can be found here.

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.