Chemicals | Monthly bulletin | May 2023

Eurofins newsflash Chemical

Europe

New version of test method for nickel release

On 22^nd February 2023, the definitive text of a new version EN 1811 was approved by CEN/CENELEC for publication and was distributed by the Central Secretariat.

This standard specifies the test method for the release of nickel from all types of articles intended to come into direct and prolonged contact with the skin, and this way to determine whether such articles are in compliance with the Entry No 27 in Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH).

Eyeglass frames and sunglasses are excluded from the scope of this standard because they are subject to the requirements of EN 16128.

The main changes of the new version EN 1811:2023 are as follows:

The unit for nickel release is expressed as in the REACH regulation (“µg·cm-2·week-1”)
Update of terms and definitions, such as: homogeneous, surface finish and disassemble
Permittable of use of ready solutions in reagents added
Notes regarding the adhesion of wax to cover cracks and fissures.
Information on number of test samples added
The following points have been clarified:
- Definition of sample area
- Handling of small samples and filtering of release solution in the release procedure.
- Filtering of release solutions and blank solutions
Test report updated:
- The minimum information required in test reports for each determination
- The following information is to be included in the test report if requested:
  - Sample area used for calculation (cm²) and the information on the areas that have been excluded
  - Volume of test solution used
  - Limit of quantification (LOQ)
Annex B, requirements for quality control material deleted
Annex B, for preparation of samples revised
Table B.1, general procedure for post assemblies and inhomogeneous articles added
Figure B.9, flowchart for sample preparation and testing procedure for complete watches added
Bibliography updated

The date of withdrawal has been set as 31st August 2023, which means that national standards conflicting with this new version have to be withdrawn by this date. However, the standard is expected to be harmonised under EU REACH Regulation (EC) No 1907/2006 once it is accepted by the European Commission.

Eight recommended substances for REACH Authorisation List

On 12^th April 2023, ECHA published its eleventh recommendation for the REACH Authorisation List. In this publication, the ECHA recommends that, the European Commission, adds the following eight substances to the Authorisation List. The European Commission will decide which substances are to be included in the Authorisation List and which conditions apply to each substance.

#	Substance name	EC No	Examples of uses in the scope of authorisation	SVHC-relevant intrinsic property
1	Ethylenediamine	203-468-6	Use as processing agent in refinery streams, corrosion inhibitors, process additives, use in control of odour emissions	Respiratory sensitiser (Article 57(f) –human health)
2	2-(4-tert-butylbenzyl) propionaldehyde and its individual stereoisomers	-	Fragrance in washing and cleaning products, air care products, polishes and waxes	Toxic for Reproduction
3	Lead	231-100-4	Batteries, ammunition, cables, vehicles, machinery, electronics, radiation shielding, sanitary, construction, art and musical instruments	Toxic for Reproduction
4	Glutaral	203-856-5	Leather tanning, X-ray film development, corrosion inhibitor, crosslinker and auxiliary for polymerisation reactions	Respiratory sensitiser (Article 57(f) –human health)
5	2-methyl-1-(4-methyl thiophenyl)-2-morpho linopropan-1-one	400-600-6	Photoinitiator in UV-curable coatings, inks and adhesives	Toxic for Reproduction
6	2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone	404-360-3	Photoinitiator in UV-curable coatings, inks and adhesives	Toxic for Reproduction
7	Diisohexyl phthalate	276-090-2	No registered uses	Toxic for Reproduction
8	Orthoboric acid, sodium salt	237-560-2	No registered uses	Toxic for Reproduction

Once these substances have been added to the REACH Authorisation List with the aim to protect workers and the environment, companies will need to apply for authorisation to continue using them.

Additional recent updates regarding REACH Regulation

The following table provides a non-exhaustive summary of some recent updates regarding REACH Regulation (EC) No 1907/2006:

Summary of the most recent updates
Date	Subject	Link
21/03/2023	Community rolling action plan update covering the years 2023, 2024 and 2025 Lists 24 substances suspected of posing a risk to human health or the environment, for evaluation by 12 Member State Competent Authorities, under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48).	More information on ECHA’s website here.
24/03/2023	A pilot project for restricted perfluorocarboxylic acids (PFCAs) Inspections as part of this pilot project will begin in 2023 and continue in 12 participating countries throughout 2024. The objective is to protect consumers from being exposed to PFCAs and related substances, including perfluorooctanoic acid (PFOA), which have been identified as substances of very high concern due to their hazardous properties.	More information on ECHA’s website here.
28/03/2023	Evaluating results from 55 extended one-generation reproductive toxicity studies under REACH. Publication of final report of the EOGRTS review project.	More information on ECHA’s website here.

Other interesting links about REACH from the ECHA’s website

Classification of substances and mixtures with endocrine disruption properties

On 31^st March 2023, the European Commission published an amendment related to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures with endocrine disrupting properties.

These substances and mixtures with endocrine disrupting properties pose a concern to public health and the environment. It has been proven that endocrine disruption can lead to certain disorders in humans, among others birth defects; developmental, reproductive or neurodevelopmental disorders; cancer; diabetes; and obesity. These disorders have a high and increasing incidence in both children, adults and animals.

This situation creates the need to establish a legal hazard identification, with classes of danger, indications of danger, pictograms and category codes, and amendment of annexes I, II, III and VI of Regulation (EC) No 1272/2008 related to the substances and mixtures with these types of properties.

It amends the following annexes to Regulation (EC) No 1272/2008, which relate to Endocrine disruption:

Annex I – Classification and labelling requirements for hazardous substances and mixtures
Annex II - Special rules for labelling and packaging of certain substances and mixtures
Annex III - List of hazard statements, supplemental hazard information and supplemental label elements
Annex VI - Harmonized classification and labelling for certain hazardous substances

For more information, consult the European Commission publication here.

Other interesting links about CLP on the ECHA’s website

Regulatory proposals notified to WTO

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number	Countries	Title
G/TBT/N/GBR/58	United Kingdom	*The Great Britain (GB) mandatory classification and labelling list (the GB MCL list).* For the purposes of transparency, the United Kingdom is signposting Members to the GB mandatory classification and labelling list, which is a list of all the mandatory classification and labelling requirements of substances and groups of substances made by the Secretary of St ate in accordance with Article 37 and Article 37A of the retained CLP Regulation (EC) No. 1272/2008 as amended for Great Britain.
G/TBT/N/GBR/60	United Kingdom	*Proposed Great Britain (GB) mandatory classification and labelling of 98 hazardous chemical substances* The purpose of this proposal is to amend the GB mandatory classification and labelling list (the GB MCL list), following review, by introducing new and revised entries for the mandatory classification and labelling of 97 hazardous chemical substances and removing one substance from the GB MCL list.
G/TBT/N/EU/966	Europe	Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures This proposal shall add new provisions to simplify labelling, by adapting the regulation to new market trends, such as online sales and digital labelling, by introducing classification rules for multi-constituent substances and by referring to new hazard classes, as well as streamlining some procedures.

France

Packaging check to transport of dangerous goods by land and sea

On 23^rd and 24^th March 2023, the French authorities published the following orders related to packaging intended for the transport of dangerous goods by land and sea:

Decree of 15 March 2023 approving the Technical Verification Office (BVT) for the inspection of packaging, large bulk containers and large packaging intended for the transportation of dangerous goods by land and sea.
Decree of March 15, 2023 approving FORM-EDIT - CeFEA Division for the control of packaging, large bulk containers and large packaging intended for the transportation of dangerous goods by land and sea.
Decree of March 15, 2023 approving the Metal Packaging Study and Research Laboratory (LEREM) for the inspection of packaging intended for the transportation of dangerous goods by land and sea.
Decree of 15 March 2023 approving the National Metrology and Testing Laboratory (LNE) for the inspection of packaging intended for the transportation of dangerous goods by land and sea.

Approval of the standard models of packaging intended for the transportation of dangerous goods and the control of the mass production of packaging in accordance with the standard models is carried out by inspection bodies approved by the Minister responsible for industrial safety. This is also the case for the periodic tests and inspections of intermediate bulk containers, and for the preliminary and periodic inspections of the industrial establishments authorised to carry out these tests and inspections themselves. These decrees authorise different entities to carry out these checks, inspections and tests.

These decrees came into force on April 1, 2023.

International

ISO 8124-3:2020+Amd.1:2023 New impact for migration of Heavy metal

On 23^rd March 2023, the International Organization for Standardization (ISO) Technical Committee: ISO/TC 181 issued a new amendment ISO 8124-3:2020+Amd.1:2023 for toy safety standards regarding heavy metal. The amendment will come into effect as long as the standard issued.

The main points of the new amendment are as follows:

Add new definition of Slime: Water-based gel or gel-like material, clear or coloured, which is viscous, slippery, and often non-Newtonian fluids, intended for play by hand manipulation, kneading and stretching.
Combine the putty definition into modelling clay as "Modelling Clay and Putty": Flexible solid or semi-solid mixtures that retain their shape and form when moulded into a shape, intended to create representations of objects by hand manipulation or to be extruded into profiles by the toy.
Add element Boron (B) migration limit for Slime and Modelling Clay and Putty:
Slime: 1250 mg/kg
Modelling Clay and Putty: 3750 mg/kg

Adjust specific element migration limit for Slime and Modelling Clay and Putty:
Slime: The migration limits for all eight elements align with those of finger paint
Modelling clay and Putty: The element Barium (Ba) migration limit is 350 mg/kg

Below are the new limits laid out by the amendment:

New limit of ISO 8124-3:2020+Amd.1:2023

Toys material	Element Limit(mg/kg)
Toys material	Antimony (Sb)	Arsenic (As)	Barium (Ba)	Cadmium (Cd)	Chromium (Cr)	Lead (Pb)	Mercury (Hg)	Selenium (Se)	Boron (B)
Any toy material given in Clause 1,except modelling clay and putty, finger paint, and slime	60	25	1000	75	60	90	60	500	--
Finger paint	10	10	350	15	25	25	10	50	--
Slime	10	10	350	15	25	25	10	50	1250
Modelling clay and putty	60	25	350	50	25	90	25	500	3750

Sustainability, environmental and circular economy

Miscellaneous technical publications relating to environmental, plastics, packaging and waste

The table below summarises the most recent publications regarding the environment, circular economy and sustainability (non-exhaustive):

Entity	Date	Publication
Direction générale de la concurrence, de la consommation et de la répression des fraudes (DGCCRF)	December 2022	Methodological note from the SCL – Analysis of nanoparticles and characterization of nanomaterials present in consumer products.
Organisation for Economic Co-operation and Development (OECD)	March 2023	WORKSHOP REPORT ON FLEXIBLE FOOD-GRADE PLASTIC PACKAGING Economic, Regulatory or Technical Barriers to Sustainable Design from a Chemicals Perspective – How Can Policy Makers Help? Series on Risk Management No. 76
The European Consumer Organization (BEUC)	March 2023	A CLIMATE-NEUTRAL FOOD BASKET TOO GOOD TO BE TRUE? 'Carbon neutral', 'CO2 neutral' or 'climate neutral', and other such types of eco-friendly claims, have sprouted on supermarket shelves in recent years. But they are scientifically inaccurate and can mislead consumers. BEUC (European Consumers' Organization) has collected some examples of these claims in 10 European countries in a recently published report. The report demonstrates their proliferation in the food sector and how these claims harm consumers.
The European Consumer Organization (BEUC)	March 2023	Promising EU plans to tackle greenwashing and promote repair
The European Consumer Organization (BEUC)	March 2023	REVISION OF THE PRODUCT LIABILITY DIRECTIVE Time to ensure effective and comprehensive protection for consumers damaged by defective products.