Europe Regulatory News

On 8 August 2023, the EU published Regulation (EU) 2023/1068 in the Official Journal of European Union amending Regulation (EU) 2019/1021 known as the Persistent Organic Polutants (POPs) Regulation. I...

On 8 August 2023, the EU published Regulation (EU) 2023/1068 in the Official Journal of European Union amending Regulation (EU) 2019/1021 known as the Persistent Organic Polutants (POPs) Regulation. In the amendment perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds are officially listed in Annex I to Regulation (EU) 2019/1021. The amendment comes into force on 28 August 2023.

PFHxS is part of the group of compounds collectively known as per- and polyfluoroalkyl substances (PFASs). It is a used as a surfactant in a variety of industrial and commercial products such as food packaging, stain and water-resistant materials, fire-fighting foams, and paint additives. PFHxS, its salts, and PFHxS-related compounds are listed in Annex A to the Stockholm Convention since June 2022 without specific exemption. Each Party to the Convention is required to prohibit the chemicals listed in Annex A and/or take the legal and administrative measures necessary to eliminate their production, use, import and export. Therefore, Part A of Annex I to Regulation (EU) 2019/1021 which contains a list of the substances listed in the Convention has been amended to include PFHxS, its salts and PFHxS-related compounds. In accordance with Regulation (EU) 2019/1021 the manufacturing, placing on the market and use of substances whether on their own, in mixtures or in articles) listed in Annex I, is prohibited (if no exemptions apply).

The amendment sets the following a limit value for PFHxS, its salts and PFHxS-related compounds occurring as an unintentional trace contaminant in substances, mixtures and articles.

• ≦ 0.025 mg/kg for PFHxS or any of its salts

• ≦ 1mg/kg for the individual PFHxS-related compounds or sum of concentrations of all PFHxS-related compounds

• For the use in firefighting foams where those limit values cannot currently be met, higher concentration limits should be established, subject to review by the Commission no later than 28 August 2026 with a view to lowering the limits.

On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral ...

On 3 July 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) adopted Opinion on Water-soluble Zinc Salts Used in Oral Hygiene Products (II). Water-soluble zinc compounds are used in oral cosmetics to minimize mouth malodor, tartar, and plaque development. Water-soluble zinc salts are now controlled under Annex III to Regulation (EC) 1223/2009 (Cosmetics Regulation). Comments are accepted until 8 September 2023.

The SCCS assessment is based on overall exposure, which takes zinc in the diet into account. For toothpaste, it suggests a safe dosage of 0.72% for infants and toddlers. For all ages, 0.1% Zn zinc in mouthwash is considered safe.

Since the use of mouthwash is not suggested for children aged 5 and under, no mouthwash exposure evaluation is undertaken for this age group.

Estimated amounts of zinc exposure for both the separate products and aggregated exposures for children (0.5-5 years and 6-17 years) and adults.

In the EU, starting from 1 January 2024, all newly submitted Poison Centre Notifications (PCNs) must comply with the harmonized information requirements detailed in Annex VIII to the Classification, L...

In the EU, starting from 1 January 2024, all newly submitted Poison Centre Notifications (PCNs) must comply with the harmonized information requirements detailed in Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation. Importers and downstream users of industrial use only mixtures must therefore be aware of the approaching deadline for poison centre compliance.

Industrial-use-only mixtures are exclusively used within industrial premises and remain inaccessible to both consumers and professionals, whether in their end-product form or through any diluted versions achieved via reformulation, such as mixtures within mixtures (MiM). An example of an industrial-use-only mixture (as a final product) could be an automotive paint used only at industrial site and accessible only by industrial end users.

There will be a one-year transitional period. Notifications for industrial-use-only mixtures that are on the market and notified before 1 January 2024 will remain valid until 1 January 2025 or until changes are made to the product (e.g. changes to the mixture composition, toxicological properties, or product identifiers). 

According to Annex VIII to the CLP Regulation, the harmonised information requirements include:

• the full chemical composition

• the toxicological information

• information about the product

• the unique formula identifier (UFI)

However, when it comes to industrial use mixtures, there is the option of making a "limited submission" where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can provide around the clock rapid access to the complete compositional details in case of an incident.

PCNs can be prepared and submitted to the European Chemicals Agency (ECHA) using the International Uniform Chemical Information Database (IUCLID). More information can be found at ECHA’s Poison Centre Website: https://poisoncentres.echa.europa.eu/.

On 19 July 2023, the European Commission amended Regulation (EC) No 1223/2009 of the European Parliament. The new regulation will prohibit the use of 31 carcinogenic, mutagenic, or toxic for reproduc...

On 19 July 2023, the European Commission amended Regulation (EC) No 1223/2009 of the European Parliament. The new regulation will prohibit the use of 31 carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in cosmetic products. The amendment comes into force on 9 August 2023 and is applicable from 1 December 2023.

The EU Commission wants to ensure legal certainty and high human health protection. All CMR substances would be included in the prohibited substances list of Regulation (EC) No 1223/2009 (Annex II) and deleted from the restricted or allowed substances lists. If conditions are met, the lists of restricted or allowed substances would be amended accordingly.

The legislation, officially published in the EU Journal on 20 July, adds the compounds to the list of restricted substances in Annex II of the Cosmetic Products legislation. The published regulation is available here.

The commission has also updated the substances list in CLP Annex VI during the 18th adaptation to technical progress (ATP) in May 2023.

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.

The European Commission adopted a Proposal for a Regulation on the management of end-of-life vehicles and standards for circularity in vehicle design on July 13, 2023. The adopted act is open for feed...

The European Commission adopted a Proposal for a Regulation on the management of end-of-life vehicles and standards for circularity in vehicle design on July 13, 2023. The adopted act is open for feedback until September 26, 2023. 

 In terms of reusability, recyclability, and recoverability of materials used in vehicles, as well as information and labelling requirements for parts, components, and materials used in vehicles, this proposed regulation establishes circularity requirements. It also specifies rules for extended producer responsibility, the collecting and disposal of vehicles at the end of their useful lives, and the export of old cars from the Union to foreign nations. 

In Europe, more than six million vehicles approach the end of their useful lives each year. Poor handling of cars near the end of their useful lives causes pollution and value loss. The evaluation of the existing EU laws governing the area, Directive 2000/53/EC on end-of-life vehicles (the "ELV Directive," adopted in 2000), and Directive 2005/64/EC on the type-approval of motor vehicles with regard to their reusability, recyclability, and recoverability ("3R type-approval Directive," adopted in 2005), has revealed that significant improvements were required to boost the transition of the automotive sector to a circular economy and thereby reducing the amount of waste that is produced. 

The transition to zero-emission vehicles depends on strengthening the EU's resilience against supply chain disruptions and lowering its reliance on imports of vital raw materials. To help the industry adapt, the Commission has updated the law and suggests a single regulation that emphasises a number of crucial components to raise design, collection, and recycling quality while simplifying reporting requirements: 

This action plan is anticipated to provide significant environmental advantages, such as: 

• A decrease in yearly CO2 emissions of 12.3 million tonnes by 2035 

• Improved material valorisation of 5.4 million tonnes 

• Higher recovery of essential raw materials 

• Long-term energy savings at the production stage and a decrease in reliance on imported raw materials. 

The European Parliament and the Council will now review the Commission's proposal for a rule on the management of end-of-life vehicles and on circularity standards for vehicle design. 

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.