Europe Regulatory News

  Importers and downstream users of industrial-use-only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notif...

Importers and downstream users of industrial-use-only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notifications (PCNs) will have to comply with the harmonised information requirements set out in Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation. 

Industrial-use-only mixtures

Industrial-use-only mixtures are used exclusively within industrial premises and remain inaccessible to both consumers and professionals, whether in their final product form or through any dilution achieved by reformulation, such as mixtures within mixtures (MiM). An example of an industrial-use-only mixture (as a final product) could be an automotive paint that is only used on an industrial site and is only available to industrial end-users.

Transitional period

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. This means that after this date, all notifications, regardless of the use type, will have to be submitted in the harmonised format.

If changes are made to the product during the transitional 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.

Information requirements

According to Annex VIII of the CLP Regulation, the harmonised information requirements include:

• The full chemical composition

• The toxicological information

• Product information

• The unique formula identifier (UFI)

However, for industrial use mixtures, there is an option to make 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 quickly access the full compositional details 24 hours per day 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 is available on the ECHA Poison Centre Website: https://poisoncentres.echa.europa.eu/.

The European Chemicals Agency (ECHA) has received a mandate from the European Commission to prepare a restriction proposal in accordance with the requirements of Annex XV of the REACH Regulation targe...

The European Chemicals Agency (ECHA) has received a mandate from the European Commission to prepare a restriction proposal in accordance with the requirements of Annex XV of the REACH Regulation targeting at least two Chromium (VI) substances. The proposal is expected to be submitted by 4 October 2024. The full text of the request can be found here.

Chromium (VI) substances

Within the EU-REACH Authorisation list (Annex XIV), there are 11 entries for Cr (VI) substances (entries 16-22 and 28-31). These substances are classified as carcinogenic (1A or 1B) and exposure to them poses a risk to both workers and the general population when exposed via the environment.

The proposed restriction will cover at least the following two Cr(VI) substances:

• Chromium trioxide (CrO3) - Annex XIV entry 16

This particular Cr(VI) substance is responsible for the majority of applications for authorisation.

• Chromic acid (H2Cr2O4) - Annex XIV entry 17

This is a group of acids produced from chromium trioxide and therefore needs to be included in the scope of the restriction proposal.

One of the main applications of these substances is in electroplating, a common surface finishing process for coating materials.

Background

The European Commission has received a substantial number of applications for authorisation of the use of the Cr(VI) substances listed in Annex XIV. This has stretched the capacity of the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) and has affected their ability to regulate other hazardous substances.

The situation also undermines one of the objectives of the authorisation provisions which is the gradual substitution of this type of substance by economically and technically viable alternative substances or technologies.

The Commission’s Mandate

As part of the restriction proposal the Commission has requested that ECHA carries out a short analysis of the availability of alternatives. ECHA should also assess whether there is a potential risk of substitution of other chromium (VI) substances. If this is the case an extension of the mandate is possible.

The preparation of the restriction proposal and its evaluation by the RAC and SEAC will follow the standard REACH restriction process. In preparing the proposal, ECHA will take into account the knowledge and experience gained from handling applications for authorisation for these substances during the preparation of the proposal.

Once the Commission adopts the restriction, the substances within the scope will be removed from the Authorisation List. This action would be a historic first under EU-REACH.

Timeline

In the best case scenario, the Commission expects that a restriction could be adopted approximately 3 years after the receipt of the mandate by ECHA.

Help for companies

The Commission has published a Q&A document to clarify the situation for affected companies. This document also addresses the main issues related to the judgment of the European Court of Justice annulling the authorisation of a consortium comprising many downstream users of chromium trioxide.

  On 4 October 2023, the European Commission notified its ‘Proposal for a Regulation of the European Parliament and of the Council on the Safety of Toys and Repealing Directive 2009/48/EC’ to ...

On 4 October 2023, the European Commission notified its ‘Proposal for a Regulation of the European Parliament and of the Council on the Safety of Toys and Repealing Directive 2009/48/EC’ to the World Trade Organization (WTO). The proposed Regulation will introduce general bans on the most harmful chemicals in toys and will require that a product passport for toys, including information on compliance. Comments will be accepted for 90 days from the date of notification.

Background

In the EU toys are currently regulated by Directive 2009/48/EC on the safety of toys. This Directive sets out the safety requirements that toys must meet in order to be placed on the EU market, whether they are manufactured in the EU or in third countries. This facilitates the free movement of toys within the Single Market.

However it has been found that there is a need for a higher level of protection against possible risks in toys, in particular those posed by harmful chemicals. In addition, the EU’s Chemicals Strategy for Sustainability (CSS) called for better protection of consumers and vulnerable groups from the most harmful chemicals. As a result, the European Commission is proposing new rules to ensure that only safe toys are sold in the EU.

Key points of the proposed Toy Safety Regulation

The new proposed Toy Safety Regulation will build on the existing legislation and update the safety requirements that toys must meet to be marketed in the EU, whether they are manufactured in the EU or elsewhere.

The proposed Regulation will mainly focus on increasing the protection from harmful chemicals but will also strengthen enforcement measures by introducing a Digital Product Passport. Details of the two measures are set out below.

1. Strengthening protection against harmful chemicals: The proposed Regulation will not only maintain the current ban on substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs), but will also ban the use of other harmful chemicals in toys. It targets chemicals that are particularly harmful for children such as endocrine disrupters, or substances toxic to a specific organ including the immune, neurological or respiratory systems. Specifically, the Regulation prohibits the use in toys of substances or mixtures classified in any of the following categories:

• Carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR): Category 1A, 1B or 2

• Endocrine disruption: Category 1 or 2

• Specific target organ toxicity: Category 1 (either in single exposure or in repeated exposure)

• Respiratory sensitisation: Category 1

Substances within these hazard classes are automatically banned in toys without the need to assess the specific risk they pose to children. 

These chemicals are particularly harmful for children as they can affect their hormones, their cognitive development or health in general. The introduction of  general bans for the most harmful substances as soon as their hazards have been established under the Classification, Labelling and Packaging (CLP) Regulation will ensure that children are protected more quickly from the possible risks of these substances when they are present in toys.

The proposed Regulation will only allow derogations from these general bans only in limited circumstances where the use of these substances in toys does not pose a risk to children and where  no alternatives are available.

The Appendices of the proposed Regulation list substances for which specific conditions such as migration limits are set. For example, nitrosamines and nitrosable substances are prohibited in toys intended for us by children under 36 months or in other toys intended to be placed in the mouth where the migration of those substances is equal to or higher than 0.01 mg/kg for nitrosamines and 0.1 mg/kg for nitrosable substances. They also set limits for, for example, flame retardants, preservatives in water-based toys, and fragrances and list substances subject to specific labelling requirements.

2. Strengthening enforcement: The proposed Regulation will ensure that only safe toys are sold in the EU. All toys will be required to have a Digital Product Passport, containing information on compliance with the proposed Regulation. Importers will have to submit Digital Product Passports for all toys at the EU borders, including for those sold online. In addition, if there are unsafe toys that pose risks not clearly covered by the Regulation, the proposal ensures that the Commission has the power to require that these toys are withdrawn from the market.

The full text of the proposed Regulation can be found here.

Timeline

The proposed Regulation will have to be adopted by the European Parliament and the Council under the ordinary legislative procedure. No precise timetable has yet been set.

On 8 September 2023, the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) adopted its opinion supporting France’ proposal to restrict the placing on the market, reuse of wood t...

On 8 September 2023, the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) adopted its opinion supporting France’ proposal to restrict the placing on the market, reuse of wood treated with creosote and related substances and banning the secondary use of such wood. The Committee for Socio-Economic Analysis (SEAC) also lends support to the proposed restriction in their draft opinion. The SEAC draft opinion is open for comments until 7 November 2023.

Understanding creosote

Creosote is a brownish-black oily liquid and is a distillation product of coal tars which themselves are by-products of the high temperature carbonization of bituminous coal. It is a complex mixture of hundreds of distinct substances, including bi- and polycyclic aromatic hydrocarbons (PAH), phenols as well as heterocyclic, oxygen-, sulphur- and nitrogen-containing substances. On average 35-43 % of creosote remains unidentified.

Creosote is classified as a Category 1B carcinogen under the Classification, Labelling and Packaging (CLP) Regulation. In addition, the Biocidal Products Committee (BPC) has identified certain components of creosote as carcinogenic, persistent, bioaccumulative and toxic (PBT) as well as very persistent and very bioaccumulative (vPvB).

Creosote is approved under the Biocidal Products Regulation (BPR) as an active substance for product-type 8 as a fungicide and insecticide against wood rotting fungi. It has been used to treat e.g. railway sleepers, agricultural fencing, and utility poles.

Current regulations for creosote

In October 2022 the approval of creosote as an active biocidal substance was renewed under the BPR for a maximum of seven years subject to several specific conditions. This approval, effective from 30 April 2023, allows creosote-based biocidal products for railway sleepers and utility poles only. Currently, the EU-REACH regulation permits some reuses and secondary uses of creosote-treated products, a provision challenged by France's proposal.

France’s proposal

The French restriction proposal targets reducing risks to health (in particular to the general public) and the environment associated with the reuse and secondary use of wood treated with creosote and creosote-related substances by amending entry 31 of Annex XVII of the REACH Regulation. As defined by the Dossier Submitter, reuse means the use for the same purpose as the original use (e.g. railway sleepers reused as railway sleepers), secondary use means the use for other purposes than the original use (e.g. railway sleepers used for agricultural fencing, residential landscaping, etc.).

Committee opinions

The RAC concluded in its opinion, that an EU-wide restriction is necessary to minimise environmental emissions and public exposure, as creosote and related substances are carcinogenic, persistent, bioaccumulative and toxic and can cause harm at very low levels of exposure.

The committee supports the ban on all secondary uses as safer alternatives are available. It aligns with SEAC’s opinion to allow reuse of creosote-treated railway sleepers and utility poles by all professionals in the same country rather than limiting it to the ‘same original user’ as proposed by France. This approach is expected to lead to greater environmental benefits compared to the purchasing of new creosote-treated wood, which is the most likely alternative. Newly treated wood is expected to leach more than older treated wood.

Additionally, the RAC considers wood creosote, one of the nine substances in France's proposal, as potentially exempt due to different hazardous properties.

Timeline

As mentioned above, the 60-day consultation of the SEAC draft opinion is open until 7 November 2023. It is expected that the committee will adopts its opinion in December 2023.

On 22 September 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published its opinion on the use of Methyl Salicylate in cosmetics for children. Methyl Salicylate, an ingredient used i...

On 22 September 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published its opinion on the use of Methyl Salicylate in cosmetics for children. Methyl Salicylate, an ingredient used in fragrance mixtures and oral hygiene products, was classified as 'Toxic for Reproduction Category 2' by the European Commission, and its safety has been assessed by the SCCS. Regulation (EU) 2022/1531 restricted its use in cosmetic products, and it is listed in entry 324 of Annex III to the Cosmetic Regulation.

The committee found that Methyl Salicylate is safe for children aged 0-3 years when used up to a maximum concentration of 0.02% in all regulated cosmetic products, except toothpaste. The use of Methyl Salicylate is safe for children aged 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, and hair conditioner. However, the SCCS has not considered the age group of children under 6 months in this safety assessment.

The SCCS has deemed Methyl Salicylate safe for use in cosmetic products for children of age 3-6 years, including shower gel, hand soap, shampoo, body lotion, face cream, lip products, and hair conditioner, up to the allowed concentrations, and safe for toothpaste up to 2.52%.

Table: Currently allowed Concentration of Methyl Salicylate in various cosmetic products

On 25 September 2023, the European Commission adopted new rules under EU-REACH to restrict microplastics intentionally added to products. The amendment, Commission Regulation (EU) 2023/2055, to Annex ...

On 25 September 2023, the European Commission adopted new rules under EU-REACH to restrict microplastics intentionally added to products. The amendment, Commission Regulation (EU) 2023/2055, to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) was published in the Official Journal of the European Union on 27 September 2023 and will enter into force on 17 October 2023.

The new rules prohibit the sale of microplastics as such and of products to which microplastics have been intentionally added and that release those microplastics when used. The restrictions are expected to prevent the release of about half a million tonnes of microplastics to the environment over the next 20 years.

Why are restrictions for microplastics needed?

Microplastics are a concern because once they are released into the environment, microplastics do not undergo biodegradation and are virtually impossible to eliminate. They accumulate in animals, including fish and shellfish, ultimately leading to their ingestion by humans when these animals become part of the food chain.

Microplastics have been detected in marine, freshwater, and terrestrial ecosystems, as well as in food and drinking water supplies Their continued release contributes to permanent pollution of our ecosystems and food chains.  Laboratory studies have established a connection between exposure to microplastics and a variety of adverse ecological and toxicological effects on living organisms.

A significant part of microplastic pollution arises unintentionally, from processes such as the breakdown of larger pieces of plastic waste, wear and tear of tires and road markings, or the washing of synthetic textiles. Nevertheless, minuscule particles of synthetic or chemically altered natural polymers are also intentionally produced for direct use or inclusion in various products.

Definition of microplastics

In the adopted restriction the definition of microplastics covers all synthetic polymer particles smaller than 5 millimetres that are organic, insoluble and resist degradation as well as fibre-like particles below 15 mm in length. However, particles smaller than 0,1 μm (0,3 μm in length for fibre-like particles) will not be taken into account.

Affected products

The following are some common products that will be affected by the restriction:

• The granular infill material used on artificial sport surfaces which represents the largest source of intentional microplastics in the environment.

• Cosmetic products where microplastics are added for purposes such as exfoliation (microbeads) or to obtain specific textures, fragrances, or colours.

• Detergents and fabric softeners

• Glitter

• Fertilisers

• Plant protection products

• Toys

• Medicines and medical devices

Derogated products

The following products can continue to be sold as they are derogated from the sale ban:

• Products used at industrial sites.

• Products that contain microplastic but do not release them during use, e.g. construction materials.

• Products already such as medicinal products, food and feed that are already regulated by other EU legislation.

Manufacturers of such products will be required to provide instructions on how to use and dispose of the product to prevent microplastics emissions. Additionally, they must report the estimated microplastics emissions annually.

Products in which microplastics are not intentionally added but are inadvertently present, such as in sludge or compost, are not in the scope of the restriction.

Transitional periods

The first measures will come into effect on 15 October 2023, such as a ban on the sale of cosmetics containing microbeads, as their use is already being phased out, as well as loose plastic glitter. As for other cosmetics products, a transitional period ranging from 4 to 12 years will apply. The specific duration of the transitional period will depend on factors such as the complexity of the product, the need for reformulation, and the availability of suitable alternatives.

The ban on infill material for sport pitches will come into effect after 8 years. This timeframe offers pitch owners and managers enough time to transition to alternative materials and allowing most existing sports pitches to naturally complete their lifespan.

The complete Commission Regulation (EU) 2023/2055 that amends the REACH regulation as regards synthetic polymer particles can be found here.

On 12 September 2023, the European Commission notified the World Trade Organization (WTO) of decisions concerning two biocidal products. The disinfectant trihydrogen pentapotassium di(peroxomonosulfat...

On 12 September 2023, the European Commission notified the World Trade Organization (WTO) of decisions concerning two biocidal products. The disinfectant trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (KPMS) was approved as an existing active substance while Willaertia magna c2c maky was rejected. The final day for comments is 60 days from notification.

Trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate)

The notified document is a Draft Commission Implementing Regulation approving trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate), in accordance with Regulation (EU) No 528/2012

of the European Parliament and of the Council (Biocidal Products Regulation (BPR)), as an existing active substance for use in biocidal products of of the product-types (PTs) 2, 3, 4, and 5 as follows:

• PT 2: For professional and non-professional users to disinfect swimming pool water. For professional users to disinfect equipment and hard surfaces. KMPS is applied onto surfaces by spraying, mopping, and wiping.

• PT 3: For professional users in the veterinary hygiene for foot dips and for terminal disinfection of animal houses with a low-pressure sprayer.

• PT 4: For professional users for surface disinfection of food and feeding areas.

• PT 5: For professional users for continuous disinfection of animal drinking water by manual dosing of the header tank or through a dosing system.

For all product-types (2-5), KMPS shows a broad spectrum of antimicrobial activity and functions as a bactericide, yeasticide, fungicide, and virucide. The Biocidal Products Committee (BPC) supported the approval of this active substance for product-types 2, 3, 4 and 5 by consensus in June 2023.

The proposed date of adoption of the regulation is January 2024 and it will enter into force 20 days from publication in the Official Journal of the EU.

Willaertia magna c2c maky

In the second notification the notified document is a Draft Commission Implementing Decision not approving Willaertia magna c2c maky as an active substance for use in biocidal products of product-type 11 in accordance with the BPR .

Willaertia magna C2c Maky is a new active substance, and it is intended to be used by professionals to prevent the growth of Legionella pneumophila in industrial processing water systems (product-type 11). The BPC supported the non-approval of this active substance since the mode of action was not sufficiently investigated.

Thermally treated garlic juice

On 4 September 2023, the European Commission also notified the approval of thermally treated garlic juice as an existing active substance for use in biocidal products of product-type 19 (repellents and attractants). Biocidal products with this active substance are used in outdoor gardens to deter cats from defecating in treated areas such as lawns and flowerbeds.