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.
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
A new definition of a nanomaterial
POP’s Persistent Organic Pollutants
Summary of the RAC and SEAC committees
Enforcement Forum Inspection Reports
Further reviews of the active substances in biocidal products
Group assessment of chemicals
Another substance on the candidate list
New developments concerning the authorisation of biocidal products
Confirmed projections of an increase in sales of heated tobacco products in EU countries
A new definition of a nanomaterial
The EC proposed new definition of nanomaterials, which will replace the one from 2011. Nanomaterial is subject to regulatory control, it has the power to regulate chemicals (REACH) as well as regulations regarding their use in certain applications, such as biocides, cosmetics or food.
The Commission adopts an agreement to protect human health and the environment against persistent organic pollutants (POPs). The agreement paves the way for the establishment of strict limits for these chemicals in waste. Existing limits have been tightened for five substances and new limits have been agreed for four new substances
The Committee adopted opinions on the harmonized classification and labelling of glyphosate and silver and the restriction of lead content in shooting and fishing ammunition. Opinion supporting the restriction of 2,4-dinitrotoluene (2,4-DNT) in articles has been completed. The Committee also adopted an opinion on the reduction of Dechlorane Plus. The consultation on the draft opinions started in June and you can submit your comments on the ECHA website.
The inspectors carried out checks on the REACH authorization requirements for substances from Annex XIV of REACH. Another project examined whether substances recovered from waste should be registered under REACH or whether they could benefit from an exemption. EU-wide inspections of biocidal products containing approved or not yet approved active substances are also ongoing until the end of the year. Reports on the results of the inspection will be published at the end of 2022.
Further reviews of the active substances in biocidal products
The ECHA Committee adopted a record number of opinions at its June meeting. They concern nine opinions on EU authorization, five on applications for active substances, including: active chlorine, calcium compounds, peracetic acid, lactic acid and IPBC. The Committee does not support the EU authorization for hydrogen peroxide in group 2. Please note that biocidal products containing approved active substances are subject to product registration under the new European procedures.
ECHA published the 4th substance evaluation report in 2021. In 2021, evaluations of over 1,900 substances were finalized, most of them grouped on the basis of their structural similarity. About 25% of the substances assessed require further risk management. Companies need to proactively update their REACH registrations with up-to-date information on substances. The ECHA report also highlights the sharp increase in the number of substances requiring harmonized classification and labeling (CLH).
N- (hydroxymethyl) acrylamide was added to the Candidate List as it may cause cancer or genetic defects. These substances may be included in the authorization list in the future. If a substance is on this list, its use will be prohibited unless companies apply for authorization and the European Commission allows them to continue using it.
New developments concerning the authorisation of biocidal products
The biocidal product SOPUROXID contains peroxyacetic acid as an active substance which is included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012. Authorised by the European Union with effect from 12 July 2022 to 30 June 2032 for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT3 (Veterinary hygiene) and PT4 (Food and feed area) in the form of a soluble concentrate for indoor industrial and professional use, method of application – hand treatment (mopping).
Confirmed projections of an increase in sales of heated tobacco products in EU countries
The European Commission has published an analysis of sales and use of heated tobacco products among consumers under 25, confirming an increase in sales at retail level of more than 10% between 2018 and 2020 in more than five Member States from data in the EU-CEG database.
We encourage you to read the current news of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
ATP-18 to the CLP Regulation
Company size verifications and corrections in REACH-IT
Next version of EuPCS
New consultations for applications for authorisation
Consultation on harmonised classification and labelling
Committee meetings in May/June
News concerning the approval of plant protection products
ATP-18 to the CLP Regulation
On May 3, 2022, the European Union (EU) issued Regulation (EU) 2022/692 to amend Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP). The revision: adds 39 new entries, replaces 17 entries, deletes 1,5-naphthylene diisocyanate. According to ATP-18, it will enter into force on May 23, 2022.
ECHA is continually initiating new verifications on the size of companies who have declared they are an SME at the time of their REACH registration. If the company realised that the company size in REACH-IT were declared incorrectly, there were short period of time to make a corrections. Such information had to be provided to ECHA via e-mail: sme-verification(at)echa.europa.eu by 31 May 2022. Administrative charge in case of wrong company size claimed is up to EUR 19 900. Ekotox Centers can help you if you need help with your REACH-IT data and dossier management.
The next version of the European Product Categorisation System (EuPCS) is planned for April 2023. Ahead of its release, ECHA was launching a survey to collect feedback on how it could be improved which was open until 18 May. The previous EuPCS vol. 2 has been updated with changes for e-liquids, medical devices, alloys, and pyrotechnic products. Companies can use the EuPCS to describe the main intended use for their mixtures when preparing their notifications in Poison Center system.
New consultations for applications for authorisation
ECHA have launched a consultation on 13 applications for authorisation covering 16 uses of:
chromium trioxide (EC 215-607-8, CAS 1333-82-0) used for etching and electroplating of plastics, in functional chrome plating, and in decorative/functional plating; and
trixylyl phosphate (EC 246-677-8, CAS 25155-23-1) used in closed systems as a hydraulic fluid.
The consultation will be open until July 13 and you can submit your comments on the ECHA website.
The agendas of the upcoming meetings of ECHA’s scientific committees are available online:
Committee for Risk Assessment will meet onsite in Helsinki on 30 May – 3 June 2022;
Committee for Socio-Economic Analysis will have a hybrid meeting on 31 May – 3 June and 7-8 June 2022; and
Biocidal Products Committee will meet online on 8-9 and 14-16 June 2022.
News concerning the approval of plant protection products
For the active substance bifenazate, the approval is extended until 30 June 2037 subject to the following conditions: only authorised for use on non-edible crops in permanent greenhouses. Conditions of use must include risk mitigation measures where appropriate.
For the active substance bispyribac, the period of approval was shortened to 31 July 2022. This was due to the withdrawal of the application for renewal of the approval.
For the active substances paraffin oils (CAS 64742-46-7, CAS 72623-86-0, CAS 97862-82-3) the conditions of use have been extended. Currently paraffin oils can be used as insecticides, acaricides and fungicides. Risk mitigation measures must be included in the conditions of use, as appropriate.
The active substance 1,3-dichloropropene is not currently approved as a plant protection product due to insufficient data to assess the risk to consumers, operators, workers, residents and concerns have been substantiated for groundwater, non-target arthropods (including bees), birds and mammals and soil organisms.
We encourage you to read the current news of EkotoxInfo chemical news.
In the summary of last month you will find the following topics:
Update of the safety data sheets by the end of 2022
Mapping of potentially harmful chemicals
Summary of the March meeting of the Biocidal Products Committee
Summary of the RAC and SEAC meeting
New CoRAP substance evaluation list for 2022-2024
Revision of the REACH and CLP regulations
Updating the registration requirements for substances in REACH
Five more substances added to the REACH Authorization List
Updating the list of chemicals subject to export notification
New developments concerning the approval of biocidal products
Update of safety data sheets by the end of 2022.
We remind you that in June 2020. Regulation 2020/878 / EU was published, amending Annex II [the content of the safety data sheet] to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The new template for safety data sheets takes into account, inter alia: the need to provide specific concentration limits, as well as multiplication factors and acute toxicity estimates; obligation to provide information on nanoform of particles and the presence of endocrine disruptors.
All existing safety data sheets without changes can be used until December 31, 2022. After this date, only safety data sheets that comply with the latest template as defined in Regulation 2020/878 / EU may be in circulation.
In 2021. ECHA assessed a total of 1900 chemicals and categorized them based on the further regulatory needs for each substance. ECHA’s goal is to review by 2027 all registered chemicals above 1 tonne per year, assign them to the appropriate category and evaluate the further regulatory action of each substance (or group of substances).
On the ECHA website you will find the full list of substances with the assigned category, or information on whether the substance is subject to further regulatory needs, whether the evaluation has already been completed or is under development.
The results of the assessment are a key issue for entrepreneurs as they can affect:
inclusion of a substance in the authorization list
restrictions on the use of certain substances, including ED substances
the need to update REACH registration
Summary of the March meeting of the Biocidal Products Committee
During the meeting, the committee adopted 3 opinions for active substances:
methylene dithiocyanate – no support for use in group 12
(13Z) -hexadec-13-en-11-yn-1-yl acetate – approval in group 9 supported
propiconazole – identified as meeting the exclusion criteria in Group 8
In addition, the committee adopted the following four positive opinions on EU authorizations:
Propan-1-ol – PT1
Propan-2-ol – PT2 and PT4
L – (+) lactic acid – PT2
Active chlorine released from sodium hypochlorite – PT2
Entrepreneurs using the substances listed in the above product groups, after their official approval, will have to apply for registration in European procedures in order to keep the products on the market.
Summary of the RAC and SEAC meeting
In March, a meeting of the Risk Assessment Committees (RAC) and the Socio-Economic Analysis Committee (SEAC) was held. Norway’s proposed restrictions on Dechlorate Plus were supported, arguing that each of the proposed options could be proportional to the benefits to society and the costs incurred. At the meeting, both committees adopted an opinion on the review and evaluation of the industrial use of 1,2-dichloroethane and two opinions on the establishment of occupational exposure limit values (OELs) for 1,4-dioxane and isoprene. In addition, 10 opinions on harmonized classification and labeling were adopted, including the classification of sulfur and multi-wall carbon nanotubes.
New CoRAP substance evaluation list for 2022-2024
The Community rolling plan (CoRAP) has been updated for the period 2022-2024 and is published on the website of the European Chemicals Agency. The plan provides for the evaluation of 27 substances suspected of posing a risk to human health and the environment. Of the 27 substances listed, two were reallocated and 25 substances were moved from the previous list (2021-2023) published on March 17, 2021. Registrants should check whether their dossiers for substances need to be updated with relevant new information, for example on hazard, tonnage, use and exposure, and that the registration dossier does not need to be updated.
Revision of the REACH and CLP regulations
The public consultation on the amendment to the REACH regulation ended on April 15, and the legislative process has moved to the next stage. The impact assessment should be finalized and presented with the Commission proposal in Q4 2022. The revision of the REACH regulation will have a significant impact on producers, workers and users of chemicals across Europe. Some planned changes to the REACH Regulation are expected to increase costs for industry. The CLP Regulation will also be subject to targeted revision, along with other sector-specific chemicals legislation, and the adaptation of the CLP revision is planned for Q2 2022.
Update of substance registration requirements in REACH
On March 24, 2022, the European Commission published amendments to Annexes VI to X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477). The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. In the second half of 2022, ECHA will publish an updated guide to registration requirements. Firms should start preparing to update their substance registration dossiers as the changes will apply in October 2022.
Five more substances added to the REACH Authorization List
ECHA has identified five substances as substances of very high concern (SVHC) due to their reprotoxic, carcinogenic or endocrine disrupting properties. The amendment of the legal act of the list of substances which cover the granting of authorization for use (Annex XIV to REACH) was published on April 11 in the EU Official Journal. Companies wishing to continue using these substances after the sunset date has been indicated will need to submit an application for authorization.
Update of the list of chemicals subject to export notification
The European Commission has updated Annexes I and V to the Prior Informed Consent Regulation (PIC Regulation, (EU) No. 649/2012). The PIC Regulation regulates the import and export of certain hazardous chemicals and places obligations on companies that wish to export these chemicals to non-EU countries. The update was released on April 20, 2022, and will take effect on July 1, 2022.
New developments concerning the approval of biocidal products
Biocide ARIEL chlorine Professional System 5 chlorine bleach for white wash – contains the active substance active chlorine released from sodium hypochlorite, which is included in the list of approved active substances. The authorisation was granted for the period from 24 April 2022 to 31 March 2032.
On the 25 April 2022, the European Commission published a “Restrictions Roadmap” as part of the EU’s Chemicals Strategy. It is in no way legally binding, but rather provides a view into future EU environmental compliance policy. The roadmap provides a list of groups of widely used chemicals of concern that will be targeted for restrictions at the European level in the coming years. This is important because this gives all stakeholders long-term visibility on planned regulatory action and thereby can facilitate existing and future substitution efforts towards safe alternatives.
The plan focuses on entire classes of chemical substances rather than regulating them individually or in small groups as is currently the case. The Restrictions Roadmap will use a group approach to regulating chemicals, in which the most harmful member of a chemical family defines legal restrictions for the whole family. If implemented as intended, thousands of chemical substances will rapidly be restricted in the EU. In total, the European Environmental Bureau (EEB) has estimated the Restrictions Roadmap will lead to the restriction of roughly 5,000 to 7,000, but industry association CEFIC say that up to 12,000 substances could ultimately fall within the scope of the new proposal, which would constitute the world’s “largest ever ban of toxic chemicals”.
European Environmental Bureau ingles out 6 groups of chemicals to be restricted:
Polyvinyl Chloride (PVC) and its additives
PFAS (non-essential uses)
Bisphenols, including BPA
Flame retardants
Chemicals in childcare products that cause cancer, genetic mutation or harm the reproductive system (CMRs)
Toxic chemicals in single use nappies / diapers
The roadmap sets out priorities for the European Chemicals Agency before the revision of the REACH Regulation (estimated for 2027). According to the roadmap, the restriction process will begin within two years by between 2025 – 2027. All substances will be gone by 2030.
COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability:
The European Commission has updated Annexes I and V to the Prior Informed Consent Regulation (PIC Regulation, (EU) No. 649/2012). The PIC Regulation regulates the import and export of certain hazardous chemicals and places obligations on companies that wish to export these chemicals to non-EU countries.
The change covers 22 chemicals, including 15 pesticides and 7 industrial chemicals. Exporters are now required to notify their intention to export these chemicals. In addition to export notification, most of these chemicals will also require the explicit consent of the importing country before export can take place. In addition, five chemicals previously only subject to export notification will now also require explicit consent.
The update was released on April 20, 2022, and will take effect on July 1, 2022.
Exporters should verify the list of chemicals they export that may be subject to additional obligations from July. The ePIC IT tool has been updated and companies can start notifying their exports now.
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