Europe Regulatory News

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH is a regulation of the European Union (EU), adopted to improve the protection of human health and the envir...

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH is a regulation of the European Union (EU), adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness chemicals industry of the EU. It came into force on 1 June 2007. REACH also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

 In a recent development, the Annex III Inventory of the REACH regulation, which comprises a compilation of substances deemed unlikely to benefit from reduced information requirements, has been officially withdrawn. Under the REACH regulation, companies are permitted to register substances with reduced information requirements, as long as these substances do not meet the criteria outlined in Annex III. Notably, the need to cross-reference the Annex III Inventory during the evaluation process to determine if a substance aligns with the criteria has been eliminated. This adjustment aims to streamline the registration process and enhance efficiency for companies navigating compliance within the framework of the REACH regulation.

 GPC can assist you to meet all your substance-related obligations under EU-REACH, such as full substance assessments, issuance of compliance certificates, and registration of chemicals. For more information, please email us at compliance@gpcregulatory.com or book a free consultation meeting here: https://meetings.hubspot.com/compliance7

On 17 August 2023, the new EU Regulation (Regulation (EU) 2023/1542) concerning batteries and waste batteries entered into force and the Batteries Directive (Directive 2006/66/EC) was repealed. In the...

On 17 August 2023, the new EU Regulation (Regulation (EU) 2023/1542) concerning batteries and waste batteries entered into force and the Batteries Directive (Directive 2006/66/EC) was repealed. In the coming years the European Chemicals Agency (ECHA) will support the European Commission with tasks aiming to make batteries safer.

The development and production of batteries are strategic priorities for Europe in the transition towards clean energy. The global demand for batteries is increasing rapidly and is predicted to have a 14-fold increase by the year 2030. To minimise the environmental impacts of this growth and considering changes in society, new technological developments, markets and the uses of batteries, the European Commission has implemented the new Batteries Regulation. Some of the keypoints of the new regulation are as follows:

• Continue to restrict the use of mercury and cadmium in batteries.

• Introduce a restriction for lead in portable batteries.

• Aim to strengthen the internal market by ensuring a level playing field through a common set of rules.

• Promote a circular economy.

• Seek to reduce the environmental and social impacts throughout the entire life cycle of batteries.

ECHA will support the European Commission in the process by:

• Assisting in preparing a report on substances of concern contained in batteries or used in their manufacturing that have negative impacts on human health, the environment or recycling for safe and high-quality raw materials. It is expected that ECHA will begin its work toward this report in 2024 and present it by 31 December 2027.

• Preparing, if requested by the Commission, a restriction proposal on harmful substances used in the manufacturing of batteries or present in batteries when they are placed on the market, and in waste batteries in accordance with Annex XV of REACH.

• Providing an opinion through the committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on the effectiveness of the restriction proposal in managing the risk and its impact on society.

Some more details on the new Battery Regulation can be found here.

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.