Europe Regulatory News

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regu...

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regulation (EC) 1272/2008. This regulation, commonly known as the CLP Regulation, deals specifically with the classification, labelling, and packaging of substances and mixtures. The regulation came into force on 25 January 2024.

The main objective of the Delegated Regulation is to make important updates to Table 3 of Part 3 of Annex VI to the CLP Regulation, which contains the list of harmonised classification and labelling (CLH) of hazardous substances. The proposed changes include the introduction of 28 new entries and the revision of 24 existing entries. The complete list is available here. The scientific assessment of these substances has been carried out in collaboration between the European Chemicals Agency (ECHA), its Committee for Risk Assessment (RAC) and the Member States authorities for decision-making at the Commission.

This proposed updates demonstrates the European Commission's commitment to keeping abreast of scientific and technical progress. The updates will play a crucial role in streamlining the harmonised classification and labelling processes and promoting consistency across the European Union. Manufacturers, importers, and downstream users are urged to stay informed about these proposed changes, as the new classifications will apply from 1 September 2025.

Harmonised classification and labelling

Manufacturers, importers, or downstream users are required to (self-)classify and label hazardous substances and mixtures in order to ensure a high level of protection for human health and the environment.

For substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and respiratory sensitisers classification and labelling should be harmonised across the EU to guarantee appropriate risk management. This is achieved through harmonised classification and labelling (CLH).

The harmonised classifications are listed in Annex VI to the Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation. All manufacturers, importers, and downstream users of such substances should apply the harmonised classifications.

Proposals for CLH can be made for substances not currently listed in Annex VI to CLP. For substances with an existing harmonised classification changes may be made due to new information, scientific or technical developments, changes in classification criteria or re-evaluation of existing data.

On 23 January 2024, the European Chemicals Agency (ECHA) announced that 5 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) due to their hazardous properties. T...

On 23 January 2024, the European Chemicals Agency (ECHA) announced that 5 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) due to their hazardous properties. This means that the Candidate List now contains 240 entries. In addition, the existing list entry for dibutyl phthalate has been updated by ECHA to include its endocrine disrupting properties to the environment.

Substances of Very High Concern

Substances of Very High Concern (SVHCs) are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC will be added to the Candidate List for possible inclusion in the Authorisation List. Some of the entries in the Candidate list are groups of chemicals, so the total number of impacted chemicals is higher. The Authorisation List has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants an authorisation for continued use.

Legal obligations for substances in the Candidate List

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation there are legal obligations for substances included in the Candidate List.

• Suppliers must inform their customers and consumers if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs.

• Suppliers of Candidate List substances, either on their own or in mixtures, must provide a safety data sheet (SDS)to their customers.

• Importers and manufacturers of articles containing a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

In addition, under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs in concentrations above 0.1 % (weight by weight). This notification is then made publicly available in ECHA's Substances of Concern in Products (SCIP) database.

New substances in the Candidate List

The uses of the five new Candidate List entries include inks and toners, adhesives and sealants as well as washing and cleaning products. The substances are persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or toxic for reproduction. The new entries (and the updated entry) added on 23 January 2024 are listed below.

In line with the EU's and the world's climate goals, the European Parliament adopted new regulations on January 16, 2024, to reduce emissions of potent greenhouse gases. In an effort to encour...

In line with the EU's and the world's climate goals, the European Parliament adopted new regulations on January 16, 2024, to reduce emissions of potent greenhouse gases. In an effort to encourage the adoption of more environmentally friendly solutions, a deal was reached with the Council to further reduce emissions of fluorinated gases (F-gases). This deal calls for the complete phase-out of hydrofluorocarbons (HFCs) by 2050 as well as stringent regulations banning the sale of products containing F-gases, which are currently used in air conditioners and refrigerators, among other applications. 

The Background 

Man-made greenhouse gases (GHGs) with a high global warming potential are known as fluorinated greenhouse gases (HFGs), which also include nitrogen trifluoride, sulphur hexafluoride, perfluorocarbons (PFCs), and hydrofluorocarbons (HFCs). Common appliances such as refrigerators, air conditioners, heat pumps, foams, aerosols, and fire protection all use them. Together with CO2, methane, and nitrous oxide, they are included in the Paris Agreement and account for around 2.5 percent of the EU’s greenhouse gas emissions.  

To support the EU’s climate goals and adhere to the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, further reductions in F-gas emissions are required. Earlier this year, the European Council and Parliament also decided adopted measures to reduce emissions of chemicals that deplete the ozone layer. 

In industries where it is technically and financially feasible to transition to alternatives that do not require F-gases, such as domestic refrigeration, air conditioning, and heat pumps, the agreement specifies phase-out dates for the use of F-gases. 

The agreement also sets strict guidelines and time limits for the use of F-gases with a high global warming potential in the repair and upkeep of various types of equipment. 

Agreement to reduce emissions of ozone-depleting substances 

• Negotiators agreed to ban the manufacture, sale, use, importation, and exportation of ozone-depleting substances (ODS). Strict exclusions are planned for the use of ODS as process agents, in laboratories, as feedstock (to create other chemicals, as in the chemical or pharmaceutical industries), and for fire protection in unique applications like military hardware and aircraft. 

• The Commission will have to establish and maintain a list of ODS which are forbidden to use as feedstock, as well as periodically evaluate the availability of substitutes, based on the four-yearly evaluations mandated by the Montreal Protocol or, alternatively, on the Commission's own initiative. 

• The management of ODS in building materials during renovation—mainly found in insulation foams—is subject to new recovery, recycling, and reclamation criteria under the revised EU framework on ODS.  

• The need for appropriate training programmes for employees involved in the recovery of ODS from foams used in construction materials was acknowledged by the negotiators. 

• The regulations pertaining to the prevention of accidental release, leak repairs, recovery, recycling, and destruction of ODS, as well as those covered by EU legislation (including those not covered by the Montreal Protocol, listed in Annex II), should be extended to all ODS covered by EU legislation in order to enhance control and monitoring of ODS and to minimise potential adverse environmental and health impacts. 

Next step 

Following the final votes in plenary on January 16, 2024, the documents will now require formal Council endorsement prior to publishing in the EU Official Journal. 

On 21 December 2023, the EU Scientific Committee on Consumer Safety (SCCS) published its final opinion on the use of Silver Zinc Zeolite (SZZ) in body sprays and deodorants. SZZ is used because of the...

On 21 December 2023, the EU Scientific Committee on Consumer Safety (SCCS) published its final opinion on the use of Silver Zinc Zeolite (SZZ) in body sprays and deodorants. SZZ is used because of the antibacterial properties of the silver ions produced. Silver ions can interact with microorganism cell membranes and electron transport systems, bind to nucleic acids, block enzymes, and catalyze the generation of free radical oxygen species (ROS). In general, the antibacterial effect is determined by the amount of silver released.

Background information

In August 2020, the Commission received a dossier supporting the safety assessment of Silver Zinc Zeolite (SZZ) as a preservative in cosmetic products, specifically in spray deodorants and powder foundations. A positive outcome could lead to the removal of SZZ from Annex II and its inclusion in Annex V to the Cosmetics Regulation. In March 2021, the Biocidal Products Committee concluded that SZZ should not be approved.

About the final opinion

The Commission requested the SCCS to conduct a safety assessment on Silver Zinc Zeolite, a preservative used in cosmetic products, based on the provided information.

The SCCS considers that Silver Zinc Zeolite (CAS No. 130328-20-0) with a maximum silver content of 2.5% is safe in spray deodorant and powder foundation when used at the recommended concentration of 1%.

From 1 January 2024, all new poison centre notifications (PCNs) in the EU for mixtures intended solely for industrial use (in addition to consumer and professional use) must comply with the harmonised...

From 1 January 2024, all new poison centre notifications (PCNs) in the EU for mixtures intended solely for industrial use (in addition to consumer and professional use) must comply with the harmonised information requirements set out in Annex VIII of the EU Classification, Labelling and Packaging (CLP) Regulation. The Regulation also requires inclusion of a unique formula identifier (UFI) code on product labels.

Notifications for industrial use only mixtures that are on the market and notified before 1 January 2024 will remain valid until 1 January 2025. This means that after this date, all notifications, regardless of the use type, must be submitted in the harmonised format.

If changes are made to the product during the transition period (e.g. changes to the mixture composition, toxicological properties, or product identifiers), a notification in the harmonised format must be submitted before the modified mixture can be placed on the market.

It is important for companies benefitting from the transition period to start planning how and when they will update their notifications and manage their re-labelling plans.

More details on the new requirements can be found here.

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 a preliminary opinion on the safety of aluminium in cosmetic products. Some background Aluminium (Al) and...

On 15 December 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published a preliminary opinion on the safety of aluminium in cosmetic products.

Some background

Aluminium (Al) and Al compounds are used in cosmetic products, in particular in deodorants, antiperspirants, lipsticks, and  toothpaste. In 2013 the Norwegian Scientific Committee for Food Safety (VKM) was mandated to evaluate the potential risk to human health from the presence of aluminium in cosmetics. In 2016, the industry submitted a new safety dossier, which was adopted in 2020. The SCCS concluded that aluminium compounds are safe when used in non-sprayable product categories and sprayable products, provided the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolized particles/droplets.

About the SCCS opinion

The SCCS states that aluminium compounds are safe when used in non-sprayable product categories at maximum levels, and in sprayable products at maximum levels, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolized particles/droplets. However, this opinion does not cover sunscreen aerosol sprays, and aluminium is not bioavailable from talc up to a level of 2%.Comments Deadline for comments

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