#regulation Tag

REACH:

Assessment of substance group published

A new report is now available for Acyl glycinates and sarcosinates.

ECHA submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) in firefighting foams in early 2022.

 

CLP:

New proposals and intentions to harmonise classification and labelling.

New intentions have been received for:

  • eugenol; 4-allyl-2-methoxyphenol (EC 202-589-1, CAS 97-53-0);
  • 2,3-epoxypropyl o-tolyl ether(EC 218-645-3, CAS 2210-79-9); and
  • Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene; Reaction products of diphenylamine with nonene, branched (EC -, CAS -).

Two proposals have been submitted for:

 

Hazardous substances:

Updates on toys regulation.

Two decrees transposing two Commission directives amending Directive 2009/48/EC on the safety of toys have been published in the Italian Official Journal. The amendments concern the ban on the use and labelling of allergenic fragrances in toys.

In particular, the decree transposing Directive 2020/2088/EU replaces the entry on citronellol and adds 61 new allergenic fragrances. In detail, the names of the allergenic fragrances shall be indicated on the toy, on the label, on the packaging and in the instructions attached to the toy, if present and added as such in the toy in concentrations greater than 100 mg/kg of the toy or its components.

 

ECHA:

Nine proposals to identify new substances of very high concern.

The substances and examples of their uses are:

  • 4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). The substance is used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
  • Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH.
  • Melamine (EC 203-615-4, CAS 108-78-1). The substance is 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). The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). The substance is used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
  • Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). The substance is used in paints and coatings.
  • Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). The substance is used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
  • 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH.

 

REACH:

Modified recommendations to registrants on how to cover mutagenicity information requirements.

ECHA’s Member State Committee (MSC) agreed to modify the approach for investigating chromosomal aberration under REACH dossier evaluation during its June meeting.

The main changes include:

To fulfil REACH Annex VIII 8.4.2 requirements, an in vitro micronucleus study (OECD Test Guideline 487) is the default test as it allows the mode of action (clastogenicity and/or aneugenicity) to be identified.

If a concern for chromosomal aberration is identified in vitro, a follow-up study combining an in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD Test Guideline 474) will be needed in most cases.

Recommendations to registrants have been modified to reflect these changes, which have applied since 1 September 2022.

The European Commission has granted an authorisation for the use of sodium chromate (EC 231-889-5, CAS 7775-11-3) to Ariston Thermo SpA with a review period expiry date on 26 August 2033.

 

Biocides:

Have your say: EFSA and ECHA guidance on the impact of water treatment processes on active substance residues in drinking water.

ECHA has collaborated with the European Food Safety Authority (EFSA) to launch a consultation on a draft guidance on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water.

The deadline for comments is 27 October 2022.

New report on European arthropods and their role in pollination 

A report has been published describing the biodiversity and the ecology of four insect orders: Diptera, Lepidoptera, Coleoptera and Hymenoptera, covering the majority of flower visiting insects. The report focuses on the sensitivity of these organisms to biocidal products.

 

SDS:

Publication of the updated version of the Guideline “SAFETY DATA SHEETS” – Part 4.

How to evaluate the (e)SDS and decide the subsequent actions” and the “Tool to verify compliance with exhibition scenarios” in the light of the changes that REACH has made in recent years to the format and content of the Safety Data Sheets and following the changes introduced by the latest revision of the ECHA Guidelines on descriptors.

 

Source: https://echa.europa.eu/it/information-on-chemicals

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Agrochemical:

  • Glyphosate: no change proposed to hazard classification

ECHA’s Committee for Risk Assessment (RAC) agrees to keep glyphosate’s current classification as causing serious eye damage and being toxic to aquatic life. Based on a wide-ranging review of scientific evidence, the committee again concludes that classifying glyphosate as a carcinogen is not justified.

https://echa.europa.eu/it/-/glyphosate-no-change-proposed-to-hazard-classification

REACH:

  • Assessments of two substance groups published.

Assessments of regulatory needs are now available for:

Methylene diphenyl ureas; and Aralkylamines

https://echa.europa.eu/it/assessment-regulatory-needs?utm_source=echa-weekly&utm_medium=email&utm_campaign=weekly&utm_content=20220601&_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

  • Consolidated texts for UK REACH and CLP laws published

https://chemicalwatch.com/484152/consolidated-texts-for-uk-reach-and-clp-laws-published

Nanomaterials:

  • Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices

https://euon.echa.europa.eu/nanopinion/-/blogs/urinary-microrna-based-early-cancer-detection-using-nanowire-based-devices?_cldee=tg0Kup3vx6_GlvuqZTICneBIo83xMR9d74aNqTQv0mfoJZqqRQF5iZbcKxRm4IXcOJFnsT_NfrOK-z3YfvJ_-g&recipientid=lead-67c0fcd4c0e0e71180fa005056952b31-948887e921a44a9db97c5ca582fa4681&esid=3f5e0192-84e1-ec11-813c-005056b9310e

Cosmetics:

  • Danish Consumer Council exposes ‘undesirable’ substances in sunscreen products

https://chemicalwatch.com/493607/danish-consumer-council-exposes-undesirable-substances-in-sunscreen-products

Food:

  • Efsa issues final list of plasticisers in FCMs prioritised for risk assessment

https://chemicalwatch.com/486442/efsa-issues-final-list-of-plasticisers-in-fcms-prioritised-for-risk-assessment

 

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CLP:

Ad hoc consultation on harmonised classification and labelling of glyphosate

The proposal for the harmonised classification and labelling of glyphosate (EC 213-997-4, CAS 1071-83-6) was proposed by Sweden and subject to a consultation, which ended on 22 November 2021.

Meanwhile, new articles potentially relevant to the classification of the substance have been published. They concern to the following hazard classes:

  • respiratory sensitisation,
  • specific target organ toxicity – single exposure (respiratory irritation),
  • germ cell mutagenicity,
  • carcinogenicity,
  • reproductive toxicity, and
  • hazardous to the aquatic environment.

ECHA is looking for comments related to these.

The deadline for comments is 12 April 2022.

 

Biocides:

Guidance on human health information requirements updated

We have published an update to the guidance document for the Biocidal Products Regulation (BPR) Volume III – Human Health – Information Requirements (Part A). The update aligns the guidance with the new information requirements of the BPR (Annexes II and III) amended by Regulation (EU) 2021/525, which will enter into force on 15 April 2022.

 

QSAR:

QSAR Toolbox updated

The web client of the QSAR Toolbox has been updated, simplifying its use. The new functionalities contain the possibility to run QSAR models or access the details of study results.

The OECD QSAR Toolbox is a freely available software for animal-free evaluation of chemical substances. It has over 25 000 users worldwide from regulatory authorities, industry, academia, and non-governmental entities. The Toolbox is co-developed by ECHA and the OECD.

 

EU PFAS restriction will have ‘very limited’ derogations, says dossier submitter:

An EU restriction dossier for a universal ban on per- and polyfluoroalkyl substances (PFASs) will have “very limited” derogations even without essential use criteria contained in it, the project lead at the Dutch National Institute for Public Health and the Environment (RIVM) has said.

The comments from one of five European competent authorities jointly preparing the dossier come after a European Commission official established last week that the restriction would not incorporate essential use because criteria would not be ready in time, even though the Montreal Protocol concept was first pictured, in the context of chemicals, for a ban on PFASs

 

Cosmetics:

European Commission begins consulting on cosmetics Regulation revision

The European Commission has begun public consultation on the targeted revision of the EU cosmetic products Regulation, which is set to introduce significant changes to the law.

It opened on 29 March and will regard five measures under consideration. They are:

·         the generic risk assessment (GRA) approach, which would automatically ban the most hazardous chemicals and only allow their use if they are found to be essential to society;

·         a new measure to account for combination effects from exposure to chemicals from different sources;

·         a review of the definition of nanomaterials;

·         improving the labelling information on cosmetic products; and

·         streamlining the scientific assessment of cosmetic products by integrating the Scientific Committee on Consumer Safety (SCCS) into Echa.

The consultation is based off of a questionnaire and is for all relevant stakeholders, ranging from EU citizens to professional users of cosmetics, industry associations, civil society organisations, and member state authorities, including those involved in customs and market surveillance.

REACH:

Resorcinol to be added to REACH candidate list after long battle

The European Commission has won its battle over the identification of resorcinol as an SVHC based on endocrine disrupting properties for human health, after its controversial draft Decision narrowly won the backing of EU member states.

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Introduction:

The end of the state of emergency will be the end of the derogation regime which, in view of the exceptional situation resulting from the SARS-cov-2 pandemic, has introduced into our legislation the possibility of placing on the market surgical masks authorised by derogation. From 1 April 2022, manufacturers who want to continue to market surgical masks in Italy will have to comply with the ordinary legislation on medical devices.

For authorised masks already placed on the market, the Circular of 4 March 2022 (https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86093&parte=1%20&serie=null ) indicates that they may be made available only until 31 May 2022 and that only masks that are part of existing stocks available to personnel participating in efforts to contain the virus and prevent its further spread may be made available until such stocks are exhausted and at the latest by 31 July 2022.

The circular of 4 March 2022 clarified certain aspects of the procedures for placing surgical masks on the market in view of the imminent expiry of the state of emergency.

The circular recalls that from 26 May 2021 it is no longer possible to place on the market surgical masks marked CE pursuant to Directive 93/42/EEC, implemented in Italy with the d.lgs. 46/97, and it is stressed that manufacturers who intend to place on the market surgical masks, must ensure compliance with the requirements of Regulation (EU) 2017/745.

 

Technical Documentation:

According to MDR 2017/745 before placing a device on the market, the manufacturer is obliged to prepare the technical documentation that must enable it to assess its compliance with the general performance and safety requirements(GSPR) set out in Annex I to the Regulation.

This documentation shall be presented in a clear, organised, unambiguous and easily searchable format and shall include methods and test results to support compliance with the specifications. For surgical masks, these are mainly tests of bacterial filtration (BFE) efficiency, respirability (Pa/cm2), microbial contamination (cfu/g), splash resistance (kPa) (only in the cases provided, type IIR masks) and biocompatibility.

The manufacturing, design and performance requirements and test methods for surgical masks are set out in UNI EN 14683:2019 “Medical face masks – Requirements and test methods”, which, although not yet harmonised in accordance with the Regulation (cf. Circular of 12 November 2021) is the main tool for the manufacturer to demonstrate the conformity of the device.

 

Quality Management System (QMS):

To ensure that series production continues to comply with the requirements of the Regulation, the manufacturer establishes, documents, applies, maintains, updates and constantly improves a quality management system, in accordance with the obligations laid down in art. 10, paragraph 9 of the Regulation.

 

Post Market Surveillance:

The manufacturer shall establish and update a post-market surveillance system throughout the life cycle of the device.

 

In conclusion, the manufacturers of surgical masks already CE marked, in accordance with Directive 93/42/EEC, and persons who have obtained derogation authorisations for the production and marketing of surgical masks having an interest in continuing to regularly place on the EU market its own masks such as medical devices, must follow all the indications contained in the Circular and in the reference standards indicated.

 

For more information:

https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5834

 

 

 

 

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WHAT HAPPENED THIS MONTH?

 

REACH:

  • The European Chemicals Agency submits a proposal for an EU-wide restriction on all per-and polyfluoroalkyl substances (PFASs) in firefighting foams. The proposal’s goal is to prevent further groundwater and soil contamination and health risks for people and the environment. 
  • ECHA has updated its recommendations to help companies improve their registration dossiers and has added more advice on using read-across and weight of evidence. Statistics are available on the progress made in evaluating registered substances in 2021.

 

Hazardous substances:

  • European Commission to end exemptions for use of mercury in certain lamps +e European Commission has published 12 delegated Acts that will end exemptions for uses of mercury in general purpose compact (CFL) and linear fluorescent (LFL) lamps, while renewing several others.

 

CLP:

  • Ad hoc consultation on the harmonized classification and labelling of S-metolachlor (ISO)

 

The proposal for the harmonized classification and labelling (CLH) of S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (RaSa)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide [contains 80-100% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20% 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide] (EC -, CAS 87392-12-9) was brought forward by Germany and subject to a consultation, which ended on 3 September 2021.

As, in the meanwhile, additional data on carcinogenicity has been released, we are looking for comments on this new information.

The deadline is 7 March 2022.

  • New proposals to harmonize the classification and labelling

 

Three proposals have been introduced for:

  • (RS)-S-sec-butyl-O-ethyl-2-oxo-1,3-thiazolidin-3-ylphosphonothioate; fosthiazate (ISO) (EC 619-377-3, CAS 98886-44-3);
  • 2,3-epoxypropyl isopropyl ether (EC 223-672-9, CAS 4016-14-2); and
  • 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one; proquinazid (ISO) (EC 606-168-7, CAS 189278-12-4).

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New Regulation sets out the requirements for the manufacture and marketing of  articles intended to come into contact with food

 

As we all know, food comes into contact with many materials and articles during its production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs).

FCMs are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use; it includes direct or indirect contact (ex. Containers for transporting food, machinery to process food, packaging materials, kitchenware and tableware).

Regulation (EC) 10/2011 (the “Plastics Regulation“) sets out the requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general rules laid down in Regulation (EC) No 1935/2004 (the “Framework Regulation”) on materials and articles intended to come into contact with food.

Article 16 of the EU food contact material Framework Regulation (EC) 1935/2004 requests the Declaration of Compliance (DoC); more details are set out in Annex IV of the Plastics Regulation (EU) 10/2011.

The DoC is a document delivered by the supplier to his customer at marketing stages up to but excluding the retailer. It has two main aims:

  • It confirms to the customer the compliance of the product with the relevant requirements of the Plastics Regulation and the Framework Regulation.
  • It provides the consumer with relevant information necessary to establish or check the compliance of the product with relevant legislation.

The purpose of the DoC is to demonstrate that the product is fully compliant with certain regulations and specify the testing methods applied to prove this. Ultimately it comes down to demonstrating that the food contact product is safe and doesn’t contain or transfer restricted chemicals or heavy metals.

It means that all European manufacturers of plastic material that comes into contact with food (including recycled plastics), active and intelligent materials, ceramics and regenerated cellulose film are obliged to issue a DoC for the articles and products they provide. For other types of food contact materials (i.e, paper, inks), DOC is not mandatory at the moment.

The DoC requirement extends all the way from the chemical supplier to any intermediate plastic supplier (suppliers of things like plastic granules and masterbatch) to the supplier of the finished plastic article, to the distributor and finally to the end-user.

According to Annex IV of the “Plastic Regulation”, there are 9 important items that have to be on a DoC:

  1. The identity and address of the business operator issuing the declaration of compliance. A DoC needs to contain information to ensure that the product is traceable if needed.

 

  1. The identity and address of the business operator that manufacturers or imports the plastic material or article. The official name and address of the manufacturing company. If the same company is issuing the DoC and manufacturing/importing the product, points 1 and 2 can be combined into one. This information, together with that contained in point one above will help

determine responsibility and traceability of the FCM if necessary

 

  1. The identity of the plastic material or article. Including the trade name, manufacturer’s code, catalogue reference number or any other code identifier that will allow the downstream user to adequately identify and trace the material. You need to know which product/products are covered in the DoC. The products should be specifically identifiable via something like an item number. With regard to the materials used, it is important to declare the type of polymer used in the material. Other materials – such as adhesives, coatings or inks – should also be listed.

 

  1. The date of the declaration. This date indicates that the product was compliant with the legislation in place at that time. Given that the legislation is ever evolving, it is possible that it can become more restrictive and compliant products can subsequently become non-compliant due to legislative amendments.

 

  1. Confirmation that the plastic material or article complies with all applicable regulations. This confirms that the plastic article is manufactured using only monomers, other substances and additives that are listed and authorised under (EU) 10/2011. The DoC should also mention that the article complies with the overall migration limit (OML). Details about the test conditions, such as any food simulants used and the OM test number according to Annex V to (EU) 10/2011, can be included.

Part of complying with (EU) 10/2011 is that a company’s manufacturing processes must comply with good manufacturing practices (GMP) as set out in Regulation (EC) 2023/2006. This regulation should therefore also be mentioned, if appropriate.

  1. Information on substances with restrictions in Annex I or II of (EU) 10/2011. This provides the identity of any substances with specific migration limits (SML) in Annex I and II of (EU) 10/2011, or information about the presence of any such substances. There should also be confirmation that the substances featuring SMLs do not migrate above the migration limit, if used under the specified conditions.

 

  1. Dual use additives. Dual-use additives are substances that can be used by food business to perform a technological function in food as well as having a function as additives in the manufacture of certain FCMs. Information on the use of dual-use additives should be provided to guarantee they are compliant with the legislation applying to Food Additives/ Flavourings and Food Contact Materials.
  2. Specifications on the use of the FCM, that includes:

(i) type or types of food with which it is intended to be put in contact; It is important to know which kind (aqueous, acidic, alcoholic, fatty and/or dry) of food the plastic product is intended for use with. Only products that have been tested in the food simulants 10% ethanol, 3% acetic acid and olive oil are suitable for use in contact with all food types. You should be aware of any restrictions in food types.

(ii) time and temperature of treatment and storage in contact with the food; How long can you use the product in contact with food and at which temperatures? This information is crucial for the safety of your food products.

(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article; This is technical information from the test laboratory about the ratio of food contact surface area to volume that has been used to determine the compliance of the product. This figure is often given in dm2/ml.

  1. Functional barrier. When a functional barrier is used in multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of the Plastics Regulation (EU) 10/2011. This point is only relevant for multi-layer articles that feature a functional barrier. This point confirms that the non-authorised additives behind the functional barrier are not mutagenic, carcinogenic or toxic for human reproduction, and are not in nano-form. It also confirms that the non-authorised substances comply with the detection limit of 0.01 mg/kg.

 

With this, you should be updated about all the requirements featured in DoC and what to look for the next time you receive one.

In order to allow the exchange of relevant information, the information to be included in the DoC is set out in standard format in Annex IV of the Plastics Regulation.

It is recommended that the DoC and the Adequate Information are issued in one or more EU languages that are easily understood both by the supplier and by the customer. The information given has to be clear and distinct. Information should relate to the actual composition of the material. Several materials with different composition leading to significant differences in reportable substances cannot be covered by one DoC.

One DoC can cover a number of variations of a material or article which differ in their size, shape, thickness or colour or in the source of supply of one or a few of the components, leading to a limited number of variations in the reportable substances, provided that all reportable substances are listed.

The EU Rules on food contact materials can be of general scope, i.e. apply to all FCMs or apply to specific materials only. EU law may be complemented with Member States national legislation if specific EU rules do not exist.

The safety of FCM is evaluated by the European Food Safety Authority (EFSA).

The safety of Food Contact Materials is tested by the business operators placing them on the market, and by the competent authorities of the Member States during official controls. Scientific knowledge and technical competence on testing methods is being maintained by the European Reference Laboratory for Food Contact Materials (EURL-FCM).

Union legislation on food contact materials at EU level aims to:

  • Protect consumers’ health
  • Ensure the effective functioning of the internal market

An EU declaration of conformity (DoC) is a mandatory document that a manufacturer or his European authorised representative (if the manufacturer is based outside the EU) needs to sign to declare that their products comply with the EU requirements.

By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product by Reg. No 10/2011 on plastic materials and articles intended to come into contact with food (the “Plastics Regulation”).

The EU Declaration of Conformity

 

 

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The planned REACH revision is one of the actions announced in the Chemicals Strategy for Sustainability

 

We have already spoken about the new discussion about polymers’ registration. Of course, this is “THE” massive change in the REACH, however it is not the only one.

As some of you have noticed, the European Commission has launched a public consultation on the revision of the REACH, with the deadline scheduled for 15th April 2022.

As part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal, the European Commission published the “Chemicals Strategy for Sustainability” the preceding on 14 October 2020.

 

  1. Increased information on critical hazards

To better protect human health and the environment, the Chemical Strategy for Sustainability has committed to increase the information requirements under REACH for all chemicals, especially for so-called critical hazards such as carcinogenicity, mutagenicity and reproductive toxicity, endocrine disruption. This may imply the need for companies (registrants of substances, i.e. manufacturers and importers of substances) to test more chemicals for more hazardous properties.

  1. Information on substances marketed at the lowest tonnage level

The REACH regulation seeks to address information deficits on chemicals by requiring manufacturers and importers to provide toxicological and ecotoxicological information on substances placed on the market in quantities of more than 1 tonne per year.

Article 138 of REACH requires the Commission to undertake reviews of the requirements for 1-10 tonnes substances and the Chemicals Strategy for Sustainability notes that information required for substances in the low and medium tonnages under REACH does not fully allow substances with critical hazard properties to be identified and their risks managed.

  1. Information requirements to provide information on endocrine disruption

As part of the impact assessment on the revision of the REACH Regulation, the Commission is assessing options for introducing standard information requirements at each tonnage level that will allow EDs to be identified.

  1. Information on environmental footprint

The Chemicals Strategy for Sustainability concludes that the EU is still lacking a comprehensive information base on all substances placed on the market and on their overall environmental footprint, including their impact on climate, and that this hinders the proper management of chemicals and products and does not allow for a full sustainability assessment. Therefore, to improve the availability of chemical data, the Chemicals Strategy for Sustainability asks for an assessment of how to best introduce information requirements under REACH on the overall environmental footprint of chemicals, including on emissions of greenhouse gases.

  1. Information requirements on use and exposure

Information on uses and exposures is one of the key building blocks of REACH, allowing registrants to implement and/or recommend operational conditions and risk management measures to downstream users (end users) that ensure the safe use of chemicals.

However, shortcomings in the currently available use and exposure data have been identified which impact regulatory management of chemical risk including the above-mentioned processes under REACH. The European Commission is therefore considering a potential revision of the registration requirements and downstream user obligations as regards the provision of information on uses and exposures.

  1. Introduction of a Mixture Assessment Factor

Various studies have shown that ‘unintentional’ co-exposure to substances can lead to adverse effects on people and the environment. Exposures at concentrations that are regarded as safe for individual substances (i.e., where no effects are expected) can still result in adverse (eco)toxicological effects when humans or other organisms are exposed to several substances together or subsequently.

Under REACH, registrants are required to document the safety of their substances, but they are not required to take into account the possibility of co-exposure to other substances. Indeed, they are seldom in a position to do so, as they usually do not have information on how other substances are used.

Assessment factors are already widely used in REACH to account for uncertainties in data: a mixture assessment factor (MAF) is a pragmatic approach to manage the unknown unintentional co-exposures.

When applying a MAF, exposure levels that are considered sufficiently safe for single chemicals are reduced by a certain factor (i.e., by MAF) to safeguard against risk from combined exposure to multiple chemicals.

The maximum risk ratio (RCR) demonstrating “safe use” for the substance is then equal to 1/MAF to account for unintentional co-exposures of substances.

  1. Changes to the provisions on the evaluation process

Companies must ensure that the information contained in their registration dossiers is correct at the time of registration and that any changes to this information are reported without delay. The REACH evaluation provisions give ECHA the responsibility to check whether registrations are in compliance.

However, update of registration dossiers by companies is still a weak point: most dossier owners do not routinely review their REACH data and most dossier updates only take place after prompting by the authorities.

The REACH review from 2018 identified specific weaknesses and opportunities to further increase the effectiveness of some of the evaluation provisions. Moreover, in relation to the announced zero tolerance approach to non-compliance, EU-wide measures are being considered to address persisting non-compliance established during an evaluation process.

  1. Including the concept of essential use in authorisations and restrictions

The Commission’s Chemicals Strategy for Sustainability outlines a number of commitments to tackle chemical pollution.

One of the commitments is to “define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health”.

At present, there is no common definition of “essential use of a chemical substance”.

Defining the criteria will be the first step. This will allow the adoption of criteria to be used in policy, ultimately to prevent the non-essential use of the most harmful chemicals, speeding up the authorization and restriction processes.

  1. Generic risk management approach

The Chemicals Strategy for Sustainability announced extending the generic risk management approach to further hazard classes and uses. This generic approach means that the existing mandate to the Commission to prohibit substances that may cause cancer (carcinogenic), gene mutations (mutagenic) or affect the reproductive system (reprotoxic), based on their hazard and on generic exposure considerations (e.g. used by consumers, used by children), will be extended to additional very harmful chemical substances and to professional uses (e.g. use by construction, equipment maintenance or cleaning workers), while allowing limited exemptions for essential uses.

This differs from a specific approach to risk management requiring proof of an unacceptable risk for each use before introducing a restriction.

 

(not exhaustive) Summary of “Chemicals Strategy for Sustainability”

Promoting safe and sustainable-by-design chemicals

The strategy promotes the transition to safe and sustainable by design chemicals and materials, which is a societal urgency as well as an economic opportunity. As a first step, the Commission is developing a framework defining the concept of ‘safe and sustainable by design’ and a set of criteria.

Achieving safe products and non-toxic material cycles

In a clean circular economy, it is essential to boost the production and uptake of secondary raw materials and ensure that both primary and secondary materials and products are always safe. the creation of a well-functioning market for secondary raw materials and the transition to safer materials and products is being slowed down by a number of issues, in particular the lack of adequate information on the chemical content of products.

To move towards toxic-free material cycles and clean recycling it is necessary to ensure that substances of concern in products and recycled materials are minimized.

As a principle, the same limit value for hazardous substances should apply for virgin and recycled material. However, there may be exceptional circumstances where a derogation to this principle may be necessary. This would be under the condition that the use of the recycled material is limited to clearly defined applications where there is no negative impact on consumer health and the environment, and where the use of recycled material compared to virgin material is justified on the basis of a case by case analysis.

Protect consumers, vulnerable groups and workers from the most harmful chemicals

One of the biggest health benefits of the EU chemicals legislation in the past decades has been the reduction in the exposure of citizens to carcinogenic substances. This has been possible in particular thanks to a preventive approach across legislation which has led to generally ban of carcinogenic substances from most consumer products.

Ample evidence and citizens’ worries justify that for the most harmful chemicals the generic approach to risk management becomes the default option.

·         Tier I: extend the generic approach to risk management to ensure that consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative

·         Tier II: extend to further harmful chemicals, including those affecting the immune, neurological or respiratory systems and chemicals toxic to a specific organ

·         Tier III: extend to professional users under REACH the level of protection granted to consumers.

A zero-tolerance approach to non-compliance

Enforcement and compliance of EU chemicals legislation must be stepped up. These are priorities to ensure the highest level of protection of health and the environment from hazardous chemicals as well as to ensure a level playing field. The Strategy announces a set of actions for all relevant players to work together – to step up enforcement of EU rules on chemicals nationally and at the EU borders, and to promote compliance.

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News sul nuovo regolamento UE n. 979/2021 della Commissione Europea

 

A decorrere dall’8 gennaio 2022 si applica il nuovo regolamento UE n. 979/2021 della Commissione che modifica gli allegati da VII a XI del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio concernente la registrazione, la valutazione, l’autorizzazione e la restrizione delle sostanze chimiche (REACH).

Tale regolamento è stato pubblicato in Gazzetta Ufficiale il 16 giugno 2021.

L’Agenzia e la Commissione, all’interno del piano d’azione comune per la valutazione REACH del giugno 2019, hanno fatto chiarezza sugli obblighi dei dichiaranti e sul ruolo e le responsabilità dell’Agenzia., introducendo prescrizioni supplementari relativamente agli studi sperimentali.

Gli allegati da VII a X del regolamento fissano le prescrizioni in materia di informazioni standard per le sostanze fabbricate o importate in quantitativi pari o superiori, rispettivamente, a una tonnellata, 10 tonnellate, 100 tonnellate o 1 000 tonnellate. L’allegato XI definisce invece le norme generali per l’adattamento del regime di sperimentazione standard di cui agli allegati da VII a X.

 

Per quanto riguarda l’allegato VII (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 1-10 ton/anno), vengono chiarite alcune disposizioni relative:

  • alle proprietà fisico-chimiche – tensione superficiale e idrosolubilità di metalli e composti metallici scarsamente solubili;
  • alle informazioni tossicologiche – studi in vitro di irritazione oculare

Per l’allegato VIII (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 10-100 ton/anno), vengono chiarite alcune disposizioni relative:

  • agli studi in vivo di irritazione cutanea od oculare e allo studio di tossicità a dose ripetuta (28 giorni). Si predilige sempre la scelta di uno studio in vitro, quando possibile;
  • allo studio di screening di assorbimento /desorbimento. Tale studio, poteva essere omesso sulla base del basso coefficiente di ripartizione ottanolo/acqua o in base alla rapida degradazione. La precisazione del nuovo regolamento impone di considerare un contesto più ampio, valutando anche altre proprietà della sostanza, come la liposolubilità, l’attività superficiale e la ionizzazione.

Per l’allegato IX (prescrizioni in materia di informazione per le sostanze nel range di tonnellaggio 100-1000 ton/anno):

  • vengono introdotte precisazioni in riferimento alla costante di dissociazione e alla viscosità, allo studio di tossicità subcronica e alla tossicità per la riproduzione;
  • vengono effettuate precisazioni sulla necessità di svolgere studi sul destino e sul comportamento della sostanza nell’ambiente, analoghe a quelle dell’allegato VIII.

Tali modifiche vengono assorbite dalla versione consolidata del REACH del 18 gennaio 2022 e sono da considerare in un eventuale aggiornamento del dossier di registrazione.

E’ già disponibile una versione draft del testo del REACH datata 1 marzo 2022 che assorbe anche la normativa più recente, il  Regolamento (UE) 2021/2204 della Commissione del 13 dicembre 2021 che modifica l’allegato XVII del REACH, per quanto riguarda le sostanze cancerogene, mutagene o tossiche per la riproduzione (CMR) .

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