Europe Regulatory News

On 30 August 2023, the European Chemicals Agency (ECHA) encouraged all registrants of micro, small and medium-sized companies (SMEs) to check if their company size was registered correctly in REACH-IT...

On 30 August 2023, the European Chemicals Agency (ECHA) encouraged all registrants of micro, small and medium-sized companies (SMEs) to check if their company size was registered correctly in REACH-IT when their substance was registered. The deadline for reporting the correct company size is 25 September 2023. By declaring and correcting the company size before the deadline only the difference to the correct registration fee has to be paid.

How to declare company size

If a company size has been reported incorrectly, ECHA must be informed at sme‑verification@echa.europa.eu. Information on how to determine and declare the company size correctly can be found here. Furthermore, documentation supporting the claim must be uploaded in REACH-IT. If the correct company size is declared before ECHA starts a verification only the difference to the correct registration fee has to be paid.

Verification of company sizes

ECHA is continually launching new verifications of the SME company sizes declared when registering with REACH. If it is discovered during such a verification that the company size was declared incorrectly, an administrative charge of up to EUR 19 900 as well as the difference to the correct registration fee must be paid.

Determination of company size category

To determine the company size category for an SME the headcount and financial figures have to be established. Instructions can be found here. The table below gives the ceilings for the headcount and the financial limits that determine if a company can be considered a micro, small or medium-sized enterprise.

The European Chemicals Agency (ECHA) has announced that IUCLID 6 will replace the REACH-IT online dossier preparation functionality. IUCLID 6 is offered via the ECHA Cloud Services (IUCLID Cloud). ...

The European Chemicals Agency (ECHA) has announced that IUCLID 6 will replace the REACH-IT online dossier preparation functionality. IUCLID 6 is offered via the ECHA Cloud Services (IUCLID Cloud).

Changes

In 2024 the following REACH-IT online dossier preparation functionality will be removed:

• Downstream user notification of authorised uses

• Classification and labelling notifcations

Timeline

In January 2024 the initial online dossier preparation will be disabled. It will still be possible to update existing online notifications until April 2024. There is no deadline for the transition from the REACH-IT online dossiers to IUCLID dossiers. An update to an existing online dossier from REACH-IT can be prepared by downloading an old dossier from REACH-IT at any time and converting the dossier file to a dataset in IUCLID.

IUCLID

IUCLID (International Uniform Chemical Information Database) is a software application designed to record, store, maintain and exchange data on the intrinsic and hazard properties of chemical substances or mixtures, their uses of these substances and the associated exposure levels. It is a key software application for both regulatory authorities and the chemical industry where it is used in the implementation of various regulatory programmes.

ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the OECD. This collaboration enables the management of the IUCLID format with the aim of harmonising as much as possible the way in which data on chemicals are collected and exchanged in regulatory settings.

IUCLID 6 on ECHA Cloud Services (https://ecs.echa.europa.eu/cloud/home.html) is free of charge and always up to date.

The European Chemicals Agency (ECHA) has prepared a draft investigation report on carcinogenic, mutagenic and reprotoxic (CMR, cat 1A or 1B) substances that may be present in childcare articles. The p...

The European Chemicals Agency (ECHA) has prepared a draft investigation report on carcinogenic, mutagenic and reprotoxic (CMR, cat 1A or 1B) substances that may be present in childcare articles. The purpose of the current investigation is to support the European Commission in the preparation of a restriction to protect children from exposure to CMR 1A or 1B substances in childcare articles.

The consultation on the draft investigation report has started on 23 August 2023. Interested stakeholders can provide their comments on the report and the appendices until 29 September 2023 (23:59 Helsinki time). Comments can be submitted here.

It is intended for interested parties such as childcare article manufacturers, importers or retailers, industry associations, consumer protection associations, testing laboratories, customs, and enforcement authorities. Both EU/EEA and non-EU stakeholders are encouraged to participate. The information submitted will be used to finalise the investigation report that will be sent to the Commission at the end of October.

The Report and Appendices can be viewed under Related Documents in this link: https://echa.europa.eu/calls-for-comments-and-evidence/-/substance-rev/74151/term

Information can be submitted confidentially and will be treated as such by ECHA. Any statement, figure or information provided via this call for evidence should be supported with a robust justification, and reference and calculation whenever relevant. Where information is submitted in this call for evidence, but no reference to sources or calculations are made to justify such information, it is unlikely that ECHA will be able take the comments into account.

For any clarifications please contact: cmrs-childcare-articles@echa.europa.eu. Information on the background for above news can be found  here.

The European Committee for Cosmetics and Consumer Health (CD-P-COS) has revised the safety criteria for cosmetic products for young children under the age of 3. The 2nd edition (2023) of safety guidel...

The European Committee for Cosmetics and Consumer Health (CD-P-COS) has revised the safety criteria for cosmetic products for young children under the age of 3. The 2^nd edition (2023) of safety guidelines includes a chapter on ingredients, aligning exposure calculations with the Scientific Committee on Consumer Safety's Notes of guidance, and updating fluoride use in toothpaste.

The CD-P-COS is leading the Council of Europe's cosmetics activities, preparing standards and policies to enhance consumer health protection. The rapid increase in children's cosmetics has put pressure on market surveillance authorities to report unsafe products via the EU's Safety Gate system. CD-P-COS's technical standards aim to alleviate this burden.

The revised edition of the guide includes the following:

• New sections on endocrine disruptors and nanomaterials

• Updated safety margin calculations for cosmetic compounds

• Updated standards for evaluating the safety of final goods

• Recommendations for using goods, such as baby wipes, terpenes, sunblock, and fluoride

• Updated research and governing body references

All consumers of cosmetic items, regardless of age, should be protected from hazardous chemicals and endocrine disruptors. To address any recognized health hazards associated with cosmetics, it is vital to keep in mind that young children are particularly vulnerable to these substances. Cosmetics' appealing packaging and other features may enhance the possibility of poisoning or choking for youngsters who consume them. The Council of Europe Resolution CM/ResAP (2012) urges European governments to ensure that cosmetic products for infants undergo an appropriate safety assessment before being released on the market.

List of substances excluded to be used in infant cosmetic products

1. Substances of very high concern that are candidates for inclusion in Annex XIV of Regulation (EC) No. 1907/2009

2. CMRs category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No. 1272/2008

3. Endocrine disruptors mentioned in Annex 15

4. Substances that are potent allergens

The European Network of Official Cosmetics Control Laboratories has closely monitored cosmetics in toys-like containers, finding banned ingredients and high allergen concentrations. Consumers should be encouraged to select care products based on their intended use.

On 25 August 2023, the European Chemicals Agency (ECHA) announced that an amendment, Commission Delegated Regulation (EU) 2023/1656, has been made adding 35 additional hazardous chemicals to the EU’...

On 25 August 2023, the European Chemicals Agency (ECHA) announced that an amendment, Commission Delegated Regulation (EU) 2023/1656, has been made adding 35 additional hazardous chemicals to the EU’s Prior Informed Consent (PIC) Regulation. The amendment enters into force on 15 September 2023 and will apply from 1 November 2023.

Added chemicals

The 35 chemicals that were added to Annex I of the PIC Regulation include 27 pesticides and 8 industrial chemicals. The full list of chemicals can be seen below. These chemicals will require export notification and in addition most of them will also require an explicit consent from the importing country before exports can take place. The IT tool ePIC has been updated accordingly and companies can already start notifying their exports. 

* Sub-category: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for public use.

** Use limitation: sr — severe restriction, b — ban (for the sub-category or sub-categories concerned)

In addition to the 35 new entries to Annex I, four chemicals (triflumuron, cyfluthrin, chlorfenvinphos, and terbufos) that were previously subject only to an export notification, will now also require an explicit consent (i.e. they have been added to Part 2 of Annex I). 

Furthermore, it was decided at the tenth meeting of the Conference of the Parties (COP) to the Rotterdam Convention to include decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex III of that Convention. That means that those chemicals are now subject to the PIC procedure under the Rotterdam Convention. Consequently, those chemicals will be deleted from Part 2 of Annex I to Regulation (EU) No 649/2012 (the PIC Regulation) and instead added to Part 3 of Annex I. The entries in Part 3 are subject to the export notification requirement, and additionally to the explicit consent, except where an import response is published in the PIC circular of the Rotterdam Convention, and certain criteria are met.

Prior Informed Consent Regulation

The PIC Regulation (Regulation (EU) No 649/2012) implements the Rotterdam Convention within the EU. It promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on how to store, transport, use and dispose of hazardous chemicals safely.

It governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU. It places obligations on companies that wish to export these chemicals to non-EU countries or import them into the EU.

The European Commission updates PIC Annex I, which lists the chemicals subject to export notification and explicit consent from the importing country. It now includes 295 entries.

On 24 August 2023, the transition period for the amendment of Annex XVII REACH regarding restriction of diisocyanates ends. The amendment, Commission Regulation (EU) 2020/1149, came into force on 23 A...

On 24 August 2023, the transition period for the amendment of Annex XVII REACH regarding restriction of diisocyanates ends. The amendment, Commission Regulation (EU) 2020/1149, came into force on 23 August 2020 and included a transition period of 3 years to allow the concerned workforce to undergo the required training.

After the end of the transition period the Restriction establishes requirements for the use and placing on the market of diisocyanates as substances on their own, as a constituent in other substances, or in mixtures for industrial and professional use(s) in concentrations above 0,1% by weight unless the user has successfully completed a training on the safe use of the substance. The training must include instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace and must be conducted by an expert on occupational safety and health. The training must be renewed at least every 5 years. Details of the required training can be found in Regulation 2020/1149 here.

Placing on the market of diisocyanates has already been restricted since 24 February 2022. The requirements are that diisocyanates cannot be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) unless the concentration of diisocyanates individually and in combination is less than 0.1 % by weight and labelled with the information ‘As from 24 August 2023 adequate training is required before industrial or professional use’.

Diisocyanates are classified as respiratory sensitiser category 1 and skin sensitisers category 1. They are mainly used to make polyurethane products, such as foams, sealants, coatings and in the automotive industry.

Restricting the use of diisocyanates is estimated to prevent over 3 000 new cases of occupational asthma a year in the EU.

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of ...

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of the European Union.

The amendment grants authorisation for the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) in the production of plastic food contact materials (FCMs) and will come into force on 31 August 2023.

In the amendment DEHCH is added Annex I of Regulation No 10/2011 which establishes a Union list of authorised substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into contact with food.

The authorisation follows a safety assessment adopted by the Panel on Food Contact Materials, Enzymes, and Processing Aids (CEP) under the European Food Safety Authority (EFSA) in December 2019 on the use of DEHCH as a plasticiser in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact with refrigerated or frozen aqueous, acidic and low-alcohol foods.

Based on a scientific study the CEP concluded that DEHCH does not raise genotoxicity concerns and that no adverse effects were observed in the toxicity studies. The CEP, however, expressed an uncertainty regarding the potential for accumulation of the substance in humans. It was therefore concluded that the migration of the substance should not exceed 0.05 mg/kg food and that it should only be used in PVC in contact with foods, for which simulants A (10 % ethanol) and B (3 % acetic acid) are assigned, at room temperature or below.