Europe Regulatory News

On the 29th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009). The objective of this revision is to ensure hum...

On the 29^th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009).

The objective of this revision is to ensure human health and improve the functioning of the internal market. It will focus on four key points:

• The use of nanomaterials in cosmetics and their definition
• The application of a generic approach on risk management (GRA) to ensure that cosmetics do not contain CMRs (carcinogenic, mutagenic, or toxic for reproduction) substances, or substances that affect the endocrine system (endocrine disruptors) or are persistent and bioaccumulative.
• Reattributing assessments of substances used in cosmetics to be lined-up with the Scientific Committee on Consumer Safety (SCCS)’s approach: “one substance, One assessment”.
• Simplification and the digitalisation of the labelling requirements.

In its preliminary assessment, the European Commission expects positive impacts in various aspects such as economy, social, and environmental. Moreover, the revision of the Cosmetic Product Regulation could have positive effects on administrative burden as it aims to harmonise the different chemical legislations and simplify the processes of compliance checks of the products.

The consultation will close on the 21^st of June and the following stakeholders are welcome to contribute to the consultation: Citizens and consumers, Professional users of cosmetic products, Manufacturers, Importers, Distributors, and other businesses (SME, Industry and SME associations, civil society organisations, member state authorities, market surveillance authorities, customs authorities, any other interested stakeholder).

The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right ...

The EU has announced that the ban on Per- and Polyfluoroalkyl Substances (PFASs) will not include the essential use criteria. This is because the essential use criteria will not be ready at the right time for the restriction proposal. The essential criteria are expected to be agreed on by the end of the year whereas the PFASs restriction process has already started.  

Due to these different timelines, the strategy to ban all uses of PFASs expect the essential use criteria will still be adapted. However, the restriction proposal will rely on existing tools to analyse the substances within this category to determine if there are safer alternatives or not, thereby determining if such substance use is essential or not. 

Due to the dossier’s complexity, the submission of the joint restriction proposal by Netherlands, Germany, Sweden, Denmark, and Norway has been postponed to January 2023, giving them a six month extension. Also, the ban’s implementation may be pushed back from 2025. 

Regarding the restrictions that are already in place for specific PFASs such as the ones used in firefighting foams, and the ones banned in persistent organic pollutants (POPs) Regulation, the Commission will decide if these existing restrictions are to be separate or merged with the universal restriction.  

The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties.  These substances include: ...

The European Commission recently added five SVHCs to the authorisation list, REACH Annex XIV due to their reprotoxic, carcinogenic or endocrine-disrupting properties. 

These substances include:

1. tetraethyl lead,
2. 4,4'-bis(dimethylamino)-4"-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone or base,
3. reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl)
4. 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE)
5. reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4- octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)

This amendment to Annex XIV is expected to take effect from April 28, 2022. For transitional arrangements, industry has till November 1, 2023, to apply for their use authorisation. Furthermore, these five substances are prohibited from market placement and use from May 1, 2025, except for companies that are granted authorisation.

On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to ...

On March 22, 2022, the European Commission held its second stakeholders’ workshop on “Safe and Sustainable by design (SSbD) criteria for chemicals and materials”. The development of criteria to assess the safety and sustainability of chemical substances is one of the main actions under the EU’s Chemicals Strategy for Sustainability.  While the relation of these criteria to specific regulatory initiatives is still unclear, they will be of immediate relevance for non-legislative initiatives and set an official definition that may serve as a basis for compliance obligations at a later stage.

At the workshop, European Commission representatives and stakeholders from civil society organisations and the chemicals industry discussed the overall framework for the assessment of the safety and sustainability of chemicals. The Commission expects to hold a follow-up webinar in April, where it will respond to the feedback provided by stakeholders.

The current proposal by the European Commission’s Joint Research Centre consists of a 4-step process. Three of the steps would relate to the safety of a chemical. Specifically, they would address its properties, its processing, and its uses. The fourth and final step would assess the environmental performance of a chemical from a life-cycle perspective.

The workshop is the second one of a series of three. A first workshop, held on 19 March 2022, presented the framework and timeline for the development of the SSbD criteria. A third and final workshop will be held in the third quarter of 2022, where specific case studies will be discussed before publication by the Commission of the criteria. The case studies currently under consideration are non-phthalate plasticisers, surfactants, and halogen-free flame retardants.

GPC is closely observing developments in relation to the EU’s Chemicals Strategy for Sustainability. Download our latest Regulatory Summary of EU Chemical policies to stay updated. 

Download here. 

On March 11, 2022, the commission announces its decision of a biocidal product in line with Regulation (EU) No 528/2012 of the European Parliament and of the Council. A product that contains capsic...

On March 11, 2022, the commission announces its decision of a biocidal product in line with Regulation (EU) No 528/2012 of the European Parliament and of the Council. A product that contains capsicum oleoresin expeller pressed to be used as a repellent against cats and dogs is classified a biocidal product. Therefore, it falls under product-type 19 which is defined by the regulation as products used to control harmful organisms like fleas, rodents, etc., by repelling either directly on the skin or indirectly in the environment.

Biocidal products are necessary, however, they pose risks to humans, animals, and the environment. The commission is committed to ensuring the movement of biocidal products in the European Union while ensuring that humans, animals, and the environment are highly protected against its risks.

Therefore, this decision notifies an addition to the list of biocidal products and the proposed date of adoption is June 2022 and comments are open till May 9, 2022.

On March 4, 2022, Sweden proposes to ECHA to identify N-(hydroxymethyl)acrylamide (with CAS No 924-42-5) in the list of Substances of Very High Concern (SVHC). SVHC list consists of substances con...

On March 4, 2022, Sweden proposes to ECHA to identify N-(hydroxymethyl)acrylamide (with CAS No 924-42-5) in the list of Substances of Very High Concern (SVHC).

SVHC list consists of substances considered to have serious effects on human health and the environment, which are usually irreversible. To use any substance in this list, authorization has to be requested. The identity of the substance and the PBT or vPvB properties and properties of equal concern are needed for commenting on this proposal.

The last day to comment is April 19, 2022. You can comment here. 

On the 7th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was m...

On the 7^th of March 2022, the EU notifies the decision to not approve N-(3-aminopropyl)-N-dodecylpropane1,3-diamine as an existing active substance for use in biocidal products. This decision was made due to the human health risks posed by the substance. The EU focuses on harmonizing the EU market for biocidal products while protecting human health and the environment.

During the assessment of the substance in 2020, ECHA identified an unacceptable risk both for primary and secondary exposure, relating to industrial users and the scenario of infants and toddlers playing on the playground, respectively. However, there is no unacceptable risk for the environment if the appropriate measures are taken. Combining the two assessments, the conclusion is that there is no safe use or mitigation measures that can be adopted for avoiding the substance’s health risks.

The final date to comment on this proposal is the 6^th of May 2022.