Europe Regulatory News

On 14 December 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published its final opinion on the use of methylparaben as a preservative in cosmetic products. Endocrine disrupting s...

On 14 December 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published its final opinion on the use of methylparaben as a preservative in cosmetic products.

Endocrine disrupting substances

The European Commission has adopted a review of Regulation (EC) No 1223/2009 on cosmetic products, focusing on substances with endocrine-disrupting properties (EDs). The review found that the Regulation adequately regulates the use of cosmetic substances that pose a potential risk to human health.  Environmental concerns raised by substances used in cosmetic products are covered by the REACH Regulation. The Commission consolidated a priority list of 28 potential EDs in cosmetics in 2019. Methylparaben is considered one of the  endocrine-disrupting substances.

About methylparaben

Methyl 4-hydroxybenzoate, also known as methylparaben, is a preservative that is regulated in various industries, including cosmetics, food products, and pharmaceuticals. It has a broad spectrum of antimicrobial activity and is effective against yeasts and  molds. Methylparaben has undergone safety evaluations by the Scientific Committee for Consumer Products (SCCP), and the SCCS in 2005, 2006, 2008, and 2011.

In response to a call for data, stakeholders submitted scientific evidence to demonstrate the safety of methylparaben as a preservative in cosmetic products. The Commission has requested the SCCS to conduct a safety assessment of methylparaben based on the information provided. Methylparaben occurs naturally in various plants and is also synthesized for use in cosmetics, food products, and pharmaceuticals.

Final opinion

Based on the safety assessment considering all available data and the concerns related to endocrine activity, the SCCS concluded that the use of methylparaben as a preservative in cosmetic products is safe at concentrations of up to 0.4 % (expressed as acid) when used alone and up to 0.8 % for mixtures of esters.

On 15 December 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published the preliminary opinion on benzophenone–4. Background The EU Cosmetics Regulation provides adequate too...

On 15 December 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published the preliminary opinion on benzophenone–4.

Background

The EU Cosmetics Regulation provides adequate tools to regulate the use of cosmetic substances that present a potential risk to human health, including those with  endocrine-disrupting (ED) properties. The Regulation addresses the environmental concerns raised by substances used in cosmetic products through the application of Regulation (EC) No 1907/2006 (REACH Regulation). The Commission commits to establishing a priority list of potential Eds not covered by bans or restrictions in the Cosmetics Regulation for their safety assessment. A public call for data was conducted for 14 substances in 2019 and 10 substances in 2021.

About SCCS opinion

2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid, also known as  benzophenone-4, is a UV filter in sunscreen products that absorbs UV light over a broad range of wavelengths to protect the skin from UVB and UVA damage. It is also listed in the European database for cosmetic substances and ingredients as a UV stabilizer and UV absorber for protecting cosmetic formulations against sunlight.

In 1999, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) evaluated benzophenone-4 and concluded that it can be safely used in cosmetic sunscreen formulations at a maximum concentration of 5%, expressed as acid, and proposed no further restrictions or conditions for its use in cosmetic products. The Commission requests a safety assessment of benzophenone-4 based on the information provided.

Considering the possible  endocrine-disrupting effects of benzophenone-4 and the results of the safety assessment, the SCCS considers that benzophenone-4 is safe to use as a UV filter up to a maximum concentration of 5% in sunscreens, pump spray, lipstick, face, and hand cream, and sunscreen propellant spray, either alone or in combination (based on deterministic aggregate exposure).

Deadline for comments

The preliminary opinion is open for public comments until 16 February 2024.

On 5 December 2023, the European Commission's Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on Titanium Dioxide. Previous SCCS Opinions on dermally applied cosm...

On 5 December 2023, the European Commission's Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on Titanium Dioxide.

Previous SCCS Opinions on dermally applied cosmetic products remain unchanged for the TiO2 grades and coatings evaluated. New dermal absorption data are needed for other TiO2 grades and coatings that are not covered by the Cosmetics Regulation 1223/2009 or entry 27a in Annex VI. Nanoform TiO2 is already restricted under entry 27a.

SCCS opinion

The Scientific Council on Consumer Safety (SCCS) has evaluated titanium dioxide (TiO2) materials in cosmetic products, including pigmentary and nano grades. The SCCS is of the opinion that the available evidence is not sufficient to exclude the genotoxicity potential of almost all TiO2 grades used in oral cosmetic products. The only exceptions are two nano grades (RM09 and RM11) for which no genotoxicity concern is indicated. More experimental data is needed to exclude the genotoxicity potential of other TiO2 grades used in oral cosmetic products. The SCCS approach to risk assessment differs from that of the European Food Safety Authority (EFSA), as cosmetic products are not meant for oral ingestion.

The SCCS recommends that the safety of pigmentary TiO2 grades in cosmetics should be assessed, as some contain more than 50% nano-sized particles.

Deadline for comments

The public can provide feedback on the SCCS draft opinion on titanium dioxide until 6 February 2024.

On 13 December 2023 the European Chemicals Agency (ECHA) published a draft of its annual update for the Community Rolling Action Plan (CoRAP). Registrants are encouraged to review the draft list of su...

On 13 December 2023 the European Chemicals Agency (ECHA) published a draft of its annual update for the Community Rolling Action Plan (CoRAP). Registrants are encouraged to review the draft list of substances scheduled for evaluation in 2024 and update their dossiers to include all relevant information before March 2024.

The draft CoRAP covers the next three years i.e. 2024-2026. The draft plan was submitted to the Member State Competent Authorities and the ECHA Member State Committee on 30 November 2023. The Committee is expected to give its opinion in February 2024 and ECHA aims to adopt and publish the CoRAP update on 19 March 2024.

The Community Rolling Action Plan includes substances suspected of posing a risk to human health and the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows such potential risks to be identified.

The draft CoRAP contains 28 substances, 11 of which are new compared to the current 2023-2025 CoRAP. Evaluation of 10 substances is planned for 2024 (including evaluation of 4 substances as a group) and the remaining 18 substances will be split for evaluation in 2024 and 2025.

The following information is provided in the draft CoRAP:

• Non-confidential substance names

• The EC/List numbers and CAS numbers

• The initial reasons for concern

• Contact details of the Member State that intends to carry out the substance evaluation.

The full list of substances included in the 2024-2026 CoRAP  can be found here.

On 4 December 2023, the European Commission published a draft delegated regulation aimed at revising a number of provisions concerning perfluorooctane sulfonic acid (PFOS) and its derivatives under Re...

On 4 December 2023, the European Commission published a draft delegated regulation aimed at revising a number of provisions concerning perfluorooctane sulfonic acid (PFOS) and its derivatives under Regulation (EU) 2019/1021 on persistent organic pollutants, commonly referred to as the POPs Regulation.

PFOS under the POPs Regulation

PFOS and its derivatives are listed in Annex I of the POPs Regulation. The Annex I listing includes Unintentional Trace Contaminant (UTC) limits in substances, mixtures and articles.

PFOS was the first per- and polyfluoroalkyl compound (PFAS) to be regulated in the EU, and the UTC values were set a long time ago. It is therefore considered unlikely that PFOS is still present in substances and mixtures at the current UTC level of 10 mg/kg.

As regards the UTC for articles, the uses of PFOS (e.g textiles and leather coating, use in semiconductors, etc.) are very similar to those of perfluorooctanoic acid (PFOA), another PFAS regulated under the POPs Regulation. There is no evidence that a different limit value than for PFOA is needed.

Modifications in the draft regulation for PFOS

For the reasons described above the following modifications for PFOS should be made:

• Align the wording of the substance identification for the entry of PFOS with that for PFOA (i.e. change ‘PFOS and its derivatives’ to ‘PFOS, its salts and PFOS-related compounds’).

• Introduction of a UTC level for PFOS and its salts of 0,025 mg/kg (in line with the one for PFOA)

• Reducing the UTC for PFOS-related substances in substances, mixtures, and articles to 1 mg/kg (in line with the one for PFOA)

• Delete of point 5 (availability of analytical methods).

• Delete a specific exemption for the use of PFOS as a mist suppressant for non-decorative hard chromium plating.

Timeline

The public consultation on the draft regulation is open until 1 January 2024. Feedback can be give here. The European Commission plans to adopt the Regulation in the first quarter of 2024.

On 7 December 2023, the European Commission proposed changes in EU Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE). The aim is to reduce hazardous ...

On 7 December 2023, the European Commission proposed changes in EU Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE). The aim is to reduce hazardous compounds in EEE to protect public health and the environment, as well as to facilitate environmentally responsible recovery and disposal of waste.  

The amount of, for example, the heavy metals and flame retardants involved would certainly pose a risk to health and the environment, especially if processed under sub-optimal conditions. This is particularly true even in cases when waste EEE is collected separately and sent for recycling. By harmonising Member State laws, the Directive also aims to guarantee functioning of the internal market. 

Background 

The RoHS Directive has contributed to the EU's efforts to minimise hazardous substances in electrical and electronic equipment (EEE) and to protect the environment and public health at various points along the value chain. 

Despite the shortcomings highlighted, the review concluded that the RoHS Directive is working well. In addition to allowing for appropriate exemptions, the Directive imposes basic restrictions on the inclusion of hazardous chemicals in EEE and, consequently in the waste of electrical and electronic equipment (WEEE). The Directive has also helped to harmonise and maintain the efficiency of the internal market by providing a level playing field for manufacturers of electrical and electronic equipment. The same level of harmonisation would not have been possible without the RoHS Directive. In addition, the RoHS Directive has gained international recognition as a standard for reducing hazardous substances in EEE, which might have a major positive impact on global health and the environment. 

Proposed changes to methodology and procedure: 

1. The Commission suggests that the European Chemicals Agency (ECHA) be given new authority for the technical assessment of time-limited exemptions and the revision process of the list of prohibited compounds in order to address concerns about transparency and promote overall consistency. 

2. The substantial conditions that serve as the foundation for the adoption of substance restrictions or related exemptions would remain unaffected by the reassignment of the assessment activities to ECHA. 

3. Such reassignment would result in more efficient procedures and enhance the "one substance - one assessment" idea that was created within the scope of the Chemicals Strategy for Sustainability. 

Suggestions for a subsequent modification 

It is possible to update and improve the provisions, so they are appropriate for the future.  

This begins with upgrading the scope (e.g., examining solar panels) and proceeds to the elimination of several transitory clauses that were pertinent when the open scope was introduced but are now superfluous. Annexes III and IV could be used to reduce the specified administrative costs associated with various EEE categories as well as the expired exemptions. 

Another possible course of action is to consider whether costs should be added to the time-limited exemption system for applications involving banned hazardous chemicals is. 

As hazardous compounds in EEE continue to be a significant topic in the context of the circular economy and zero-pollution goals, the RoHS Directive could be enhanced improved. 

The interaction with other legal instruments currently under reviewed and the possibility of changes to the RoHS Directive (e.g., the REACH Regulation) will make a future amendment necessary as well.  

To read the full proposal click here https://environment.ec.europa.eu/system/files/2023-12/COM_2023_760_1_EN_ACT_part1_v4.pdf 

On 5 December 2023, the European Parliament and the Council reached a provisional agreement on the revision of the Regulation on the Classification, Labelling and Packaging of Chemicals (CLP). The new...

On 5 December 2023, the European Parliament and the Council reached a provisional agreement on the revision of the Regulation on the Classification, Labelling and Packaging of Chemicals (CLP). The new measures will improve the protection of consumers, workers and the environment, while improving the functioning of the EU market for products containing hazardous chemicals. The revised regulation will improve communication on hazardous chemicals including for chemicals sold online. It will also speed up the identification of hazardous chemicals and mixtures at EU level.

CLP Regulation

The CLP Regulation is the basis for the EU legislation on the risk management of chemicals. It implements the United Nation’s Globally Harmonised System (GHS) for the classification and labelling of chemicals in the EU. Manufacturers and importers are required to classify, label and package their hazardous chemicals in accordance with the CLP Regulation before placing them on the market.

The legislative proposal to revise the CLP Regulation was presented by the European Commission on 19 December 2022. As part of the revision package, the European Commission adopted a Delegated Act adding definitions and criteria for the classification of substances and mixtures with the following properties into established hazard classes:

• Endocrine disrupting

• Persistent, bioaccumulative and toxic

• Very persistent and very bioaccumulative

• Persistent, mobile and toxic

• Very persistent and very mobile

This Delegated Act entered into force on 20 April 2023.

Content of the revision

The key changes introduced by the revision of the CLP Regulation are as follows:

• Clearer labelling of hazardous chemicals: The revision introduces advertising requirements and a minimum font size for labels on hazardous chemicals. The requirements also apply to online sales.

• Digital labelling: Companies will have the option of using fold-out labels and digital labelling. Important information and hazard pictograms must still be displayed on the packaging.

• Online purchases: Websites will have to display the hazardous properties of the products leading to better protection for consumers when buying hazardous chemicals online.

• Complex substances: The rules for classifying complex substances (known as ‘more than one constituent substances’ (MOCS)) have been updated. A specific derogation was agreed upon for plant extracts including essential oils.

• Classification proposals: The Commission will also have the right to develop classification proposals for potentially hazardous substances in addition to Member States and the industry. This will speed up the identification of hazardous substances.

• Refillable chemicals: To support the safe sale of household chemicals in bulk the first rules on refillable chemicals will come into force. The use of refillable chemicals will reduce packaging and therefore packaging waste.

• Poison centres will receive better and faster information for medical emergencies.

Once adopted these changes, together with the new hazard criteria for endocrine disrupters, persistent and toxic chemicals that came into force in April 2023, will ensure better communication and identification of chemical hazards.

Next steps

The new Regulation will now have to be formally adopted by the European Parliament and the Council. Once formally adopted, it will enter into force 20 days after its publication in the Official Journal of the EU.