The legal framework for regulating chemicals in the EU is Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH came into force on 1 June 2007.
REACH requires registration of chemical substances that are manufactured or imported into the EU in quantities of 1 Tonnes per Annum (TPA) or more, unless the substance is exempted from the scope of registration. This applies to substances on their own, in mixtures, or in articles when the chemicals are intended to be released under normal or reasonably foreseeable conditions of use of the article. Registered substances can in principle circulate freely on the internal market.
European REACH regulation is currently in the Evaluation Phase and substances and dossiers are being evaluated. The evaluation phase, within which your substance of interest may be, can be checked in the following tab “Check the Regulatory Status of the Registered Substances (evaluation phases)”. Further you can find updates on other EU regulations such as EU-Cosmetic, Poison Centre Notification (PCN) (with deadline to notify on or before 31st Dec. 2020), and SCIP database notification for articles containing SVHC to have notification requirements (5th Jan 2021).
Check the Evluation status and PCN requirements for your substance
Sep-27-2023
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.
Sep-22-2023
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.
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