Chemicals | Monthly bulletin | February 2022

Eurofins newsflash Chemical

Europe

New update of Candidate List of Substances of Very High Concern (SVHCs)

On 17^th January 2022, the ECHA (European Chemicals Agency) has released the new Candidate List of SVHCs. With the addition of 4 new substances, the current list of SVHCs contains 223 substances.

Below a table with the last substances included:

Nº	Substance name	EC number	CAS number	Reason for inclusion
1	tris(2-methoxyethoxy)vinylsilane	213-934-0	1067-53-4	Toxic for reproduction (Article 57c)
2	S-(tricyclo(5.2.1.0'2,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate	401-850-9	255881-94-8	PBT (Article 57d)
3	6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol	204-327-1	119-47-1	Toxic for reproduction (Article 57 (c))
4	(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) (3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 1782069-81-1 (1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 95342-41-9 (1S,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 852541-25-4 (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one EC No.: 253-242-6 \| CAS No.: 36861-47-9 (1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 741687-98-9 (1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 852541-30-1 (1R,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one EC No.: - \| CAS No.: 852541-21-0	-	-	Endocrine disrupting properties (Article 57(f) - human health)

Click here for getting the official List from ECHA’s website.

Amending Annex XVII to REACH Regulation

On 15^th December 2021, the European Union (EU) published Regulation (EU) No 2020/2081 with an amendment to, Annex XVII to Regulation (EC) No 1907/2006 of REACH as regards substances in tattoo inks or permanent make-up, which entered in force on 4^th January 2022.

This amendment adds the entry 75 of the Annex XVII and Appendix 13 – list of substances with specific concentration limits related to tattoo inks.

For more information about Tattoo inks and permanent make-up, consult the ECHA website here.

TiO₂ ban in food can be expected to other applications in near future

On 14^th of January, the European Commission published Regulation 2022/63 which bans the use of Titanium dioxide as colorant for food. The transitional period for the use is 6 months. This ban is exclusively applicable for the use of TiO₂ as food additive but it can be expected that this ban will also influence other applications for instance for the use of TiO₂ as pigment used in printing inks or in packaging for food. Also the pressure on the use of TiO₂ in cosmetic products is already increasing.

The Regulation will entry into force on 7^th February 2022.

Quantitative limits in 2022 for substances that deplete the ozone layer

On 20^th December 2021, the European Commission published the Commission Implementing Decision (EU) 2021/2257 which determinate the quantitative limits and allocating quotas for substances controlled under Regulation (EC) No 1005/2009 of the European Parliament and of the Council on substances that deplete the ozone layer, for the period 1^st January to 31^st December 2022.

Additional recent updates regarding REACH

The below table showcases a summary of the most recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

Summary of the Most Recent Updates
Date	Subject	Link
23/12/2021	Restriction on the placing on the market and use of substances containing polycyclic aromatic hydrocarbons (PAHs) in clay targets for shooting.	For more information about Submitted restrictions under consideration here.
23/12/2021	Publication of assessment concluding that at present there is no need to restrict the use of arsenic acid in articles in accordance with article 69(2) of REACH. However, ECHA will continue to monitor the situation, especially through their databases of substances of very high concern in articles (SiA and SCIP).	For more information on Assessment report for arsenic acid here
23/12/2021	European Court of Justice confirms identification of bisphenol A as an endocrine disrupter to human health.	For more information, consult the jusgement C-876/19 P here.
23/12/2021	Publication about the Horizon 2020 project about nanomaterials and their physicochemical characterization.	The Nanopinion guest column here.
17/01/2022	Updated SCIP candidate list package available	For more information, consult the ECHA website here.
19/01/2022	ECHA has submitted a proposal to restrict the use of per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams.	For more information, consult the ECHA website here.

Other interesting links about REACH from ECHA’s website

European public initiatives

Please find below a table summarising recent public initiatives (non-exhaustive):

Feedback period	About this initiative
20 January 2022 – 15 April 2022	Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment The chemicals strategy for sustainability announces actions to better protect people and the environment against hazardous chemicals and to encourage innovation to develop safe and sustainable alternatives.
30 November 2021 – 18 January 2022	Microplastics pollution – measures to reduce its impact on the environment This initiative aims to tackle microplastics unintentionally released into the environment. It will focus on labelling, standardisation, certification and regulatory measures for the main sources of these plastics.
28 October 2021 – 23 December 2022	Hazardous waste - updated concentration limits for chemical pollutants Persistent organic pollutants (POPs) are poisonous chemicals that break down slowly and get into the food chain, harming the environment and our health. The European Commission is once again reviewing the limits of POPs substances to: ensure that such waste is managed in an environmentally sound way achieve safer recycling.

Technical publications

Please find below a table summarising recent technical publications (non-exhaustive):

Date

Entity

Title

15/12/2021

EFSA

(European Food Safety Authority)

Bisphenol A: EFSA draft opinion proposes lowering the tolerable daily intake

EFSA has re-evaluated the risks of bisphenol A (BPA) in food and proposes to considerably lower the tolerable daily intake (TDI) compared to its previous assessment in 2015. The public consultation is opened until 22 February 2022.

Recent Updates regarding CLP

The table below showcases a summary of the most recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

Summary of the Most Recent Updates
Date	Subject	Link
23/12/2021	Poison centres webinar recap: presentations and Q&A published	For more information, consult the ECHA website here.

Other interesting links about CLP from ECHA’s website

France

Bisphenol A as a substance of very high concern

On December 21^st 2021, the Court of Justice of the European Union confirmed on appeal the identification of Bisphenol A as a substance of very high concern (SVHC) for its endocrine disrupting properties for human health.

Ministère de la transition écologique has information available about this substance and the situation in France and Europe. Check their website for more information here.

Recent updates regarding UK REACH and GB CLP

The below table showcases a summary of the most recent updates (non-exhaustive) regarding UK REACH and GB CLP:

Summary of the Most Recent Updates
Date	Subject	Link
06/01/2022	Updating the GB mandatory classification and labelling list (GB MCL List)	HSE GB CLP publication table can be consulted here.

PFOS - New substances in California Proposition 65 list

On 24^th December 2022, perfluorooctane sulfonic acid (PFOS) and its salts and transformation and degradation precursors was added to the list of chemicals of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) by the Office of Environmental Health Hazard Assessment (OEHHA). The reason is that these substances have carcinogenic properties which was confirmed by the Carcinogen Identification Committee (CIC) on 6^th December 2021.

For more information, consult the OEHHA website here.

New flame retardants requirements in New York

The bill S4630B - Family and Fighter Protection Act was signed by the New York Governor. It bans the use of certain flame retardant chemicals in furniture and mattresses and also bans the use of certain flame retardant chemicals in electronic casings.

Beginning January 1^st 2024, the bill prohibits the sale of mattresses, or upholstered furniture that contain intentionally added identified flame retardant chemicals. As of January 1^st 2024 no person may offer for sale an electronic display that contains intentionally added organohalogen flame retardants.

For more information and additional effective dates, check the official publication here.

Oregon adds five new chemicals to HPCCCH list

On 1^st January 2022, the following five chemicals were added to the list of high priority chemicals of concern for children's health (HPCCCH). The Oregon Health Authority (OHA) announced a Permanent Rule Revision to Clarify Reporting and Revise Reportable Chemical List related to the Toxic Free Kids Act.

Entry	Chemical	CAS no	PQL (ppm)	Method
14	Dicyclohexyl phthalate (DCHP)	84-61-7	25.0	CPSC-CH-C1001-09.3
16	Diisobutyl phthalate (DIBP)	84-69-5	25.0	CPSC-CH-C1001-09.3
52	Bisphenol F (BPF)	620-92-8	1.0	Total Extraction/ EPA 1694
56	Ethylhexyl diphenyl phosphate (EHDPP)	1241-94-7	50.0	Total Extraction/ GC-MS
72	Chlorinated paraffins	108171-26-2	50.0	Total Extraction/ GC-MS

It entered in force on 1^st January 2022.

California Prop 65 settlement agreements in consumer goods

In 2021, several settlements have been reached for a variety of goods containing Prop 65 chemicals. Some of these agreements allow a Prop 65 warning as an alternative. Below, a summary (non-exhaustive) with some relevant chemicals involving consumer goods and the last Prop 65 settlement agreements:

Chemicals	Hazards	Example of goods	Reformulation/warnings
Chromium (VI)	Cancer and reproductive toxicity	Gun slings, Leather hand grips	Warning for chromium (VI)
Bisphenol A (BPA, CAS 80-05-7)	Reproductive toxicity	Lab set glasses/goggles	BPA-free otherwise warning
		Airpod cases	≤ 3 ppm BPA otherwise warning
		Socks ( polyester with spandex)	Reformulation of the product or exposure warning
N-nitrosodiethylamine (NDEA, CAS 55-18-5)	Cancer	Latex resistance bands, swim caps	≤ 10 ppb n-nitrosodiethylamine (NDEA)
Perfluorooctanoic acid (PFOA, CAS 335-67-1)	reproductive toxicity	Makeup foundations	≤ 0.1 mg/kg PFOA for products in solid form ≤ 0.1 mg/L PFOA for products in liquid form
Di(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7)	cancer, birth defects, other reproductive harm or their combination cancer, birth defects, other reproductive harm or their combination	Cat mats	< 0.1% otherwise warning
		Headbands	≤ 1000 ppm otherwise warning
		Sleep bags	≤ 0.1% otherwise warning
Di-n-butyl phthalate (DBP, CAS 84-74-2)		Recharge hose	≤ 0.1% otherwise warning
Di-isodecyl phthalate (DIDP, CAS 68515-49-1 and 26761-40-0)		Notebook accessory mobile phone holders	< 0.1% otherwise warning
Diisononyl phthalate (DINP)		Children's suitcases, luggage, and accessory items with plastic components, Suitcases and luggage items with plastic components	≤ 0.1% otherwise warning
Phthalates: Butyl benzyl phthalate (BBP, CAS 85-68-7), di-n-hexyl phthalate (DnHP, CAS 84-75-3), DBP, DEHP, DIDP and DINP		Chair covers, Pet rain slickers, Tool kits, Vinyl covers	< 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP, otherwise warning
		Jackets/coats, Handle grips, Costume footwear, Vinyl/PVC jump rope cords and handle grips	≤ 0.1% each of BBP, DBP, DEHP, DIDP, DINP and DnHP, otherwise warning
Lead	Birth defects and reproductive harm	Ceramic planters	≤ 90 ppm lead and ≤ 1 μg lead (NIOSH 9100), otherwise warning
		Holiday decor bells with exterior decorations	≤ 90 ppm lead and ≤ 1 μg lead (NIOSH 9100), otherwise warning
		Ceramic photo frames	≤ 1 μg lead (NIOSH 9100) otherwise warning

For more information, consult the Search 60-Day Notice website here.

California - Revision of Prop 65 warning in short form

On 24^th December 2021, the California's Office of Environmental Health Hazard Assessment (OEHHA) issued the extension of the comment period for modification of text for proposed rulemaking – short form (Proposition 65) which was opened on 13 December 2021.

This public comment has the aim to modify Text Title 27, California Code of Regulations Proposed Amendments to Article 6 Clear and Reasonable Warnings – Short Form. The proposed rulemaking would amend the safe harbor warning regulations to improve the short-form warnings to provide consumers more specific information, and to limit the use of the safe harbor short form warning to small products.

These proposed changes are summarized below:

The maximum label size for short form warnings is increased from 5 square inches to 12 square inches.
The use of short form warning on websites and in catalogs is allowed.
Additional signal word options “CA WARNING” or “CALIFORNIA WARNING” to allow businesses to make clear that the warning is being given pursuant to California law.
An additional warning option that more directly addresses exposure to carcinogens or reproductive toxicants to provide an additional safe harbor warning that can be used on the product label.
The word “product” was removed and remains the term "label" from the proposed term “product label”.

The new deadline to accept comments was on 14^th January 2022.

International

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/MEX/505	Mexico	Draft Mexican Official Standard PROY-NOM-007-SCT2-2021: Provisions relating to the construction, UN marking and testing of packaging/containers, intermediate bulk containers (IBCs) and large packagings/containers used to transport dangerous goods. It is binding on shippers and consignees of dangerous goods within their areas of responsibility, as well as on manufacturers (builders) and distributors engaged in the construction and reconstruction of the packaging/containers, IBCs and large packagings/containers, who must ensure that each one can pass the tests referred to in this Mexican Official Standard, and on the person providing the dangerous goods to be transported, who must guarantee that the packaging/containers, IBCs and large packagings/containers comply with this Mexican Official Standard.
G/TBT/N/MEX/504	Mexico	Draft Mexican Official Standard PROY-NOM-011-SCT2/2021: Conditions for transporting dangerous goods packed in limited quantities It is binding on shippers, carriers and consignees of the specified dangerous goods.
G/TBT/N/EU/865	Europe	Proposal for a Regulation of the European Parliament and of the Council amending Annexes IV and V to Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants (COM(2021)656 final) It amends the annexes that deal with waste in the Regulation (EU) 2019/1021 (the POPs Regulation). These annexes set limits for persistent organic pollutants in waste and determine how waste that contains POP substances has to be managed in the EU.
G/TBT/N/TPKM/478	Taiwan, Penghu, Kinmen and Matsu	Proposal for Legal Inspection Requirements for Polyvinyl Chloride Floorcoverings. Polyvinyl chloride (PVC) products are possible to have plasticizer contamination, resulting in environmental hormone effects and carcinogenic risk due to the exposure to PVC.