Europe Regulatory News

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. 

On the 23rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency ...

On the 23^rd of February 2022, the REACH Annex XV restriction dossier was published addressing PFASs’ risks in firefighting foams to human health and the environment. The European Chemicals Agency (ECHA) proposes an EU-wide restriction on all per- and polyfluoroalkyl substances (PFASs) in firefighting foams.

The proposal by ECHA is aimed at preventing further contamination of the soil and its health risks to people and the environment. It is known that PFASs have caused environmental contamination to the soil and drinking water in the EU.

If adopted, there will be a transition period for industries to replace PFASs in the firefighting foams. Industries will also have to properly dispose expired and waste foams while transitioning away from using these PFASs. The consultation period for this proposal starts from the 23^rd of March 2022 for six months, during which anyone can give comments.

Based on the proposal, the transition period will include:

• three years for civilian ships
• five years for portable fire extinguishers
• five years for any other use
• 8 months for training and testing
• 10 years for fire service establishments covered by the Seveso Directive, and
• 18 months for municipal fire services (except if they are also in charge of establishing industrial fires, which is covered by the Seveso Directive)

European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Conside...

European Commission publishes 12 delegated acts to end the exemptions for the use of mercury in lamps. These lamps include general-purpose compact (CFL) and linear fluorescent (LFL) lamps. Considering the wide availability of mercury-free alternatives, this announcement will enter into force on March 16, 20 days from when it was published. The EU Member States have six months to modify their national legislation to include these delegated acts.

Before now and according to the EU rules (RoHS Directive) that restricts the use of hazardous substances in electronic equipment, electronics with mercury can only be placed on the market when certain exemptions are given by the Commission.

However, according to this new announcement, the Commission cancels all exemptions regarding the use of mercury. Mercury-free alternatives are widely available for industries and manufacturers to use. This is in response to the proposal submitted to the European Parliament and Council in December 2021.