ECHA is looking for comments on nine proposals to identify new substances of very high concern. Give comments by 17 October 2022.
Helsinki, 7 September 2022 – The substances and examples of their uses are:
4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). Used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
Melamine (EC 203-615-4, CAS 108-78-1). Used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). Used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.
The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
Safety Data Sheets (SDS) are documents for communicating information on the hazards of chemicals and mixtures and the risks they pose to human health and the environment.
The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS):
COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements.
The new requirements include:
Alignment of SDS with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revisions 7 and 8;
Inclusion of Unique Formula Identifiers (UFIs) to Section 1 (in line with Regulation (EU) 2017/542);
Additional information requirements for substances placed on the market as a nanoform (in line with Regulation (EU) 2018/1881) and for substances and mixtures with endocrine-disrupting properties;
Addition of the Specific Concentration Limits (SCLs), multiplying factors and acute toxicity estimates (ATE), if available, set in accordance with CLP 1272/2008.
The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12.
Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.
Notifications from 1 026 sites across Europe submitted by May 2021. confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.
Enforcement authorities can now carry out inspections as necessary.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets.
The chromium trioxide applications for REACH authorisation by companies is now accelerating.
Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.
Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!
On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
DDAC – biocidal active substance approval is coming
Legal procedure for implementing changes to the CLP Regulation
Update of the Blue Guide
Skin sensitizing substances in consumer mixtures
SSbD – Safe and sustainable design
New concerning the authorisation of biocidal products
News on cosmetic products
DDAC – biocidal active substance approval is coming
There is already a draft Commission Implementing Regulation (EU) approving didecyldimethylammonium chloride as an active substance for use in biocidal products of product groups 1 and 2, in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. If you sell DDAC products for PT1 PT 2 product groups, you must apply under the new European procedures before the indicated deadline.
Legal procedure for implementing changes to the CLP Regulation
The last meeting raised the question of whether the European Commission has the power to adopt amendments under the current CLP legislation. The Commission plans to adopt some changes to its mandate under the CLP revision by means of a delegated act without the involvement of the European Parliament.
The European Commission has published an update of the Blue Guide, which provides information on the implementation of EU product rules and their implementation on the European market. The guide aims to better understand EU rules on products and to facilitate their uniform application in all sectors across the single market.
France, Ireland and Germany invite interested parties to submit information on skin sensitisers in mixtures intended for consumers. Deadline for data delivery: 30/09/2022.
The JRC technical report has been published. “Safe and sustainable design of chemicals and materials” containing a framework of criteria and definitions for the safety assessment of chemicals and materials.
New concerning the authorisation of biocidal products
Germany has requested the European Commission to approve the authorisation for the biocidal product group L+R Propanol PT1 Family for professional use only. The evaluating country was Switzerland. L+R Propanol PT1 Family contains propane-1-ol and propane-2-ol as active substances which are included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. The authorisation for PT 1 (Human personal care) has been granted until 30 June 2032.
Belgium has requested the European Commission to approve the authorisation for the Contec Hydrogen Peroxide Biocidal Product Family for professional use only. The evaluating country was Slovenia. Contec Hydrogen Peroxide Biocidal Product Family contains hydrogen peroxide as an active substance which is included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product type 2 . The authorisation for PT 2 (Disinfectants and algaecides not intended for direct application to humans or animals) has been granted until 30 June 2032.
Germany has requested the European Commission to approve the authorisation of the biocidal product Bioquell HPV-AQ for professional use only. The Netherlands was the evaluating country. Bioquell HPV-AQ contains hydrogen peroxide as an active substance which is included in the list of approved active substances
Union’s list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 31 July 2032.
Belgium has requested the European Commission to approve the authorisation for INTEROX Biocidal Product Family 1 for professional use only. The evaluating country was Finland. INTEROX Biocidal Product Family 1 contains hydrogen peroxide as an active substance, as an active substance included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algicides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 30 July 2032.
Germany has requested the European Commission to approve the authorisation for the Knieler & Team Propanol Family of biocidal products for industrial and professional use. The evaluating country was Switzerland. Knieler & Team Propanol Family contains propane-1-ol and propane-2-ol as active. substances which are included in the Union list of approved. active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product types 1, 2 and 4. Authorisations for PT 1 (Human personal care), PT 2 (Disinfectants and algicides not intended for direct application to humans or animals) and PT 4 (Food and feed area) were granted until 31 July 2032.
Commission Regulation (EU) 2022/1181 regulates the threshold for formaldehyde-releasing substances as a preservative in both non-washable and washable cosmetic products.
The use of formaldehyde is prohibited in cosmetic products due to its classification as a carcinogen (category 1B). Annex V to Regulation (EC) No 1223/2009 lists the substances that are allowed to be used as preservatives in cosmetic products. Some of the substances listed release formaldehyde gradually to perform the function of preservative in the final cosmetic product. In order to inform formaldehyde-sensitive consumers about the presence of formaldehyde, which can cause an allergic reaction, a threshold of 0,05 % (500 ppm) is set in the finished product and the product must be labelled with a specific warning ‘contains formaldehyde’.
The Scientific Committee on Consumer Safety concluded that the current threshold does not sufficiently protect. formaldehyde-sensitive consumers and therefore proposed to lower the current threshold. to 0.001% (10 ppm), regardless of whether the product contains one or more formaldehyde-releasing substances.
All finished products containing formaldehyde-releasing substances that comply. with the requirements of Regulation (EC) No 1223/2009. as applicable from 30 July 2022 may be placed on the Union market until 31 July 2024 and may. be made available on the Union. market until 31 July 2026.
Commission Regulation (EU) 2022/1176, based on the opinion of the Scientific Committee. on Consumer Safety, tightens the concentrations for Benzophenone-3 and Octocrylene used. as UV filters in cosmetic products due to their properties as potential endocrine disruptors.
The substance Benzophenone-3 is safe for the consumer when used as a UV filter:
in concentrations up to 2.2 %: Cosmetic body products including in aerosol spray and pump spray form
in concentrations up to 6 %: Cosmetic products for face, hands and lips, excluding aerosol spray and pump spray products
When used at a concentration of 0,5 % to protect. the composition of the product, the content used as a UV filter shall not exceed 1,7 %.
The substance Octocrylene is safe for the consumer when used as a UV filter:
at a concentration of up to 10 % alone
in concentrations up to 10 %: Cosmetic products for face, hand and lip, except aerosol spray and pump spray products
in concentrations up to 9 %: Aerosol spray products
SSdB – JRC Technical Report published – Safe and sustainable by design chemicals and materials – Framework for the definition of criteria and evaluation procedure for chemicals and materials.
The EU Chemicals Strategy for Sustainability (CSS) action plan foresees the development of a framework to define safe and sustainable by design (SSbD) criteria for chemicals and materials.
The SSbD is an approach to support the design, development, production and use of chemicals and materials that focuses on providing a desirable function (or service), while avoiding or minimising harmful impacts to human health and the environment.
The SSbD concept integrates aspects for the domain of safety, circularity and functionality of chemicals and materials, with sustainability consideration throughout their lifecycle, minimising their environmental footprint. SSbD aims at facilitating the industrial transition towards a safe, zero pollution, climate-neutral and resource-efficient economy, addressing adverse effects on humans, ecosystems and biodiversity from a lifecycle perspective.
Skin sensitising substances in consumer mixtures: Current call for comments and evidence
The France, Ireland and Germany request interested parties to submit information on skin sensitising substances in mixtures intended for consumers, including data on types of uses, planned substitutions, epidemiological data on allergic contact dermatitis and information on healthcare costs.
Deadline for providing input: 30/09/2022.
The objective of this Call for Evidence is to gather information on:
the sectors, and type of uses/applications concerned,
measures currently in place (e.g. changed formulation, reduction of concentration, specific packaging, conditions of use) to minimise consumer exposure,
experience regarding substitution efforts, availability and costs of alternatives or reasons for non-substitution,
the potency of the skin sensitising substances and their technical functions in the mixtures,
on safe use of consumer products,
epidemiology of allergic contact dermatitis and other health-related information including health costs,
analytical methods to detect the presence of skin sensitising substances in mixtures.
For any clarifications, please contact the German Competent Authority: chemg (at) baua.bund.de
The Blue Guide on the implementation of the product rules 2022 is published
The European Commission has published an update of the Blue Guide, which provides information on the implementation of EU product rules and their implementation on the European market. It is a collection of information on product law. The guide aims to better understand EU rules on products and to facilitate their uniform application in all sectors across the single market.
The product rules are aligned with the New Legislative Framework, which covers for instance toys, measuring instruments, radio equipment, low voltage electrical equipment, medical devices, fertilising products. The Blue Guide also provides explanations and advice regarding the European conformity assessment system, the accreditation of laboratories, the CE marking, and market surveillance.
The new version includes, inter alia, the new market surveillance regulation. It also elaborates on specific features such as distance sales, making products available on the market subject to physical modifications or software updates and the assessment of conformity assessment bodies.
One of the actions listed under the Chemicals Strategy for Sustainability under the European Green Deal is the targeted revision of the Regulation on classification, labelling, and packaging of substances and mixtures (CLP). The revision is expected to cover a number of issues as e.g. introducing new hazard classes (e.g. for endocrine disruptors) but also addressing practical issues with labelling or notification of information to poison centres.
CLP is a regulation of the European Parliament and of the Council, therefore all amendments to the regulation should be adopted under the ordinary legislative procedure, however, the European Commission has been empowered to amend certain parts, so in practice it can amend the annexes and certain articles by means of a delegated act instead of the ordinary legislative procedure.
The Commission plans to adopt certain amendments within the scope of its empowerment in the framework of the CLP revision via Delegated act. These amendments aim at introducing new hazard classes and criteria to assess some additional hazards to human health and the environment displayed by chemical substances and mixtures.
The question was raised whether the Commission is empowered to adopt such amendments under the current provisions of CLP.
The most important question is whether adding new hazard classes (such as endocrine disruptors and Persistent Bioavailable and Toxic) can be considered a non-essential element of the CLP Regulation that could be amended by the European Commission without the involvement of the European Parliament?
Didecyldimethylammonium chloride (DDAC) as an active substance in the biocidal products PT 1 and PT 2 will be approved most probably in 2024.
Draft Commission Implementing Regulation (EU) …/… approving didecyldimethylammonium chloride as an active substance for use in biocidal products of product-types 1 and 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Having biocidal products (BP) on the EU market registered under provisional conditions means that staying on the market you need to start preparing and submitting applications for authorisation in time.
Some countries will not accept applications submitted later than one year before the deadline for approval. You need to check carefully.
Also requirements for authorisation under BPR require much more of data, time and investments then for original registration of biocidal product. For example testing on the BP could be necessary to prove the efficacy. Analytical protocols need to by done for the final product with validity test for active ingredient(s) and substances of concern…
Failing to meet the deadlines means that you must stop selling products and remove them from the market.
In summary
Check that you have active national registrations in the Member States in which you want to continue seling your products under BPR.
Make a data gaps analysis.
Make a strategy.
Conduct studies, data gathering, dossiers development etc.
Apply in time for national authorisation or EU wide under the BPR.
In case you need help – experts of Ekotox Centers could help – just contact us !
Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
Ekotox Centers
Tel +421 2 45943712
e-mail on ekotox(at)ekotox.eu
We offer support and preparation of all documents. Required for registration / authorisation of a biocidal product for placing on the market in EU member states.
When you use our website, we may collect information to operate and improve your experience through cookies. By closing or accepting, you agree this use of cookies.Accept cookiesDeclinePrivacy policy
