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Consumer Products | Bimonthly bulletin | May 2021

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Europe

ECHA proposes seven substances for authorisation to be included in Annex XIV

ECHA recommends that the European Commission add the following seven substances to the Authorisation list.

Substance name	Hazardous properties	Examples of uses in the scope of authorization
Octamethylcyclotetrasiloxane (D4)	PBT, vPvB	Electronic articles production, non-metal surface treatment
Decamethylcyclopentasiloxane (D5)		Electronic articles production, dry cleaning, scar and wound treatment
Dodecamethylcyclohexasiloxane (D6)		Formulation of personal care, washing and cleaning products, scar and wound treatment
Terphenyl, hydrogenated	vPvB	Heat transfer fluid, plastics, adhesives, sealants
Dicyclohexyl phthalate (DCHP)	Toxic for reproduction, Endocrine disrupting	Phlegmatizer in organic peroxides, plasticiser in polymers
Disodium octaborate	Toxic for reproduction	Paints, adhesives, construction materials
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA)	Respiratory sensitising properties	The substance has no uses in the scope of authorisation but is recommended based on grouping considerations as it could potentially replace two structurally similar substances (HHPA and MHHPA) used as epoxy resin hardeners that have already been recommended. This is to avoid regrettable substitution.

The final decision to include these substances of very high concern (SVHCs) in the Authorisation List will be taken by the European Commission together with the EU Member States and the European Parliament. These decisions will also indicate the sunset date, as well, as the latest application date.

Once on Annex XIV, companies will need to apply for authorisation to continue using them.

Revision of REACH and CLP regulations

The Commission has published two inceptions impact assessments (roadmaps), one on the revision of REACH and the other on CLP, looking for stakeholder feedback. These roadmaps describe possible options on how to change the two pieces of legislations to solve some of the following issues (non-exhaustive list):

Gaps in knowledge of many substances including intermediates, polymers and substances in the lowest tonnage range and no assessment of risks is required for non-threshold substances.
Incomplete information about hazards to human health and the environment
The registrant´s safety assessments do not take combination effects of chemicals into account.
The authorisation procedure is too heavy and inflexible and the restriction process is too slow to sufficiently protect consumers and professional users against risks from hazardous substances.
The control and enforcement is not equally effective in all Member States.

The deadline to submit comments is 1 June 2021. Give comments on REACH | Give comments on CLP

Updated guidance on safety data sheets

ECHA´s guidance on safety data sheets has been revised in line with the latest version of Annex II to REACH according to Regulation (EU) 2020/878 and translations are now available. The content has been updated to reflect changes introduced by the new legal text, including on nanoforms, the unique formula identifier (UFI), endocrine disrupting properties, and an expanded Section 9 covering physical and chemical properties. It also provides an explanation of the application of the two-year transition period (until 31^st December 2022).

Existing SDSs compliant with Regulation (EU) 2015/830 may be used only until 31^st December 2022, the deadline to update all existing SDSs to be compliant with Annex II.

More information is available on ECHA´s website.

The European Union sets a limit as UTC for pentachlorophenol under the POP Recast Regulation

On 23^rd February this year, the European Union published Regulation (EU) 2021/277 amending Annex I to Regulation (EU) 2019/1021 on persistent organic pollutants as regards pentachlorophenol and its salts and esters.

Pentachlorophenol (PCP) is toxic to human health and the environment and it is used as preservative for wood, leather and textiles to protect against the attack of moulds, fungus and bacteria.

When the POP Recast regulation was published, pentachlorophenol and its salts and esters were listed in Annex I without an Unintentional Trace Contaminant (UTC) limit value. However, the European Commission determined the presence of these substances as an impurity in some articles, including imported textiles and recovered wood chips for the production of wood panels. To allow the continuation of recycling of wood chips and to facilitate the enforcement, a UTC limit equal to or below 5 mg/Kg (0,0005% by weight) was set under “Specific exemption on intermediate use or other specification” in Part A to Annex I to POP Recast Regulation. This limit value applies to PCP, its salts and esters when they are present in substances, mixtures or articles. This amendment became effective on 15^th March.

In addition, on 2^nd February this year, the European Union published Regulation (EU) 2021/115 amending Annex I to POP regulation as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds.

Proposal to list chlorpyrifos as Persistent Organic Pollutant (POP)

The Council decision asks the European Commission to submit a proposal on behalf of the European Union to list chlorpyrifos (EC 220-864-4, CAS 2921-88-2) in Annex A to the Stockholm Convention on persistent organic pollutants. The manufacture and use of substances in this annex is prohibited.

After the submission later this spring, the POPs Review Committee will discuss the proposal next autumn.

The Council Decision (EU) 2021/592 was published in the Official Journal on 13^th April 2021.

Updated Poison centre guidance on Annex VIII to CLP Regulation to help companies notify

The guidance on Annex VIII to CLP (version 4.0) has been updated addressing issues identified by certain industry sectors resulting from the requirements for poison centre notifications introduced in 2017.

The guidance has been updated to reflect changes concerning bespoke paints that are formulated in stores to satisfy customer demand. Sector–specific solutions have also been included for fuel, petroleum and construction products, as mixtures used in these sectors often have a high or unpredictable composition variability. The solutions help companies to reduce the number of notification and unique formula identifiers (UFIs) required. The labelling and packaging guidance has also been updated to reflect changes concerning bespoke paints.

More information is available on ECHA´s website.

Updated the Community rolling action plan (CoRAP) for the years 2021-2023

The updated Community rolling action plan (CoRAP) for the years 2021 – 2023 lists 58 substances for evaluation by the Member State competent authorities under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). The plan contains three newly allocated substances and 55 substances already published in the previous CoRAP update on 18 March 2020. The substances are distributed for evaluation in years 2021, 2022 and 2023 between 16 Member States.

Eight of the substances are planned to be evaluated in 2021, while the rest are listed for evaluation in 2022 and 2023. Registrants are invited to consider if dossier updates would be needed to bring new relevant information, for example, on tonnages, use and exposure.

More information is available on ECHA´s website.

SVHCs list public consultation

On 9^th March 2021, The European Chemicals Agency (ECHA) opened a public consultation on proposed substances of very high concern (SVCHs) to be included in the Candidate list in the 25^th update, in summer 2021. The deadline for receiving comments was until 23th April 2021.

The proposed substances are:

Name	EC number	CAS number	Consumer uses
1,4-dioxane	204-661-8	123-91-1	There are no consumer uses, but it cannot be excluded that there are uses of substances or related mixtures, where 1,4-dioxane is contained as constituent or impurity.
2,2-bis(bromomethyl)propane1,3-diol (BMP) 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) 2,3-dibromo-1-propanol (2,3-DBPA)	221-967-7 253-057-0 202-480-9	3296-90-0 36483-57-5 1522-92-5 96-13-9	Polymer production manufacture of plastics products
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers	-	-	It is used in many different uses such as coatings and paints, thinners, paint removes; Fillers, putties, plasters, modelling clay; Finger paints, Ink and toners
4,4'-(1-methylpropylidene)bisphenol; (bisphenol B)	201-025-1	77-40-7	It may be used in the manufacture of phenolic and polycarbonate resins and it has a structure similar to Bisphenol A.
Glutaral	203-856-5	111-30-8	In leather tanning, finishing, impregnation and cosmetics/personal care between other uses.
Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17]	-	-	In rubber articles; Paper products; Textile (fabrics, textiles, apparel, and leather articles); PVC (plastic articles); Production of cables (machinery, mechanical appliances, electrical/electronic articles).
Orthoboric acid, sodium salt	237-560-2	13840-56-7	Uses include solvent and corrosion inhibitor
Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)	-	-	The substance is further used in the manufacture of chemicals, rubber products and plastic products.

For more information, read the official publication on the ECHA website here.

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
26/04/2021	Companies must review registrations transferred from the UK More than 8 000 UK-based registrations have been successfully transferred to companies in the EU, EEA or Northern Ireland. These companies must review and, if needed, update the information in these registrations.	For more information, visit the ECHA’s website here
21/04/2021	ECHA identified 290 chemicals as candidates for regulatory action In 2020, ECHA assessed around 1.900 registered chemicals in groups. 290 of these may be candidates for further regulatory risk management at EU level if their hazards are confirmed. Most of these will require more data to be generated and confirmation of hazards before any actions take place.	For more information, visit the ECHA’s website here
24/02/2021	REACH Evaluation Joint Action Plan Evaluation activities were sped up by checking similar chemicals in groups in a more efficiently manner for the assessment. In 2020, ECHA checked 1900 chemicals to identify needs for further assessment. Registrations for 258 chemicals were also checked for compliance with REACH requirements. Better quality safety data from companies is still needed to clarify the long-term effects of chemicals on human health or the environment. ECHA published the list of the substances evaluated in 2020 including details on the information requests that have been issued to companies as part of ECHA´s recommendations on how to improve their registration data.	For more information, visit the ECHA’s website here
24/02/2021	Implementation of the REACH action Plan for review/improvement of Registration Dossiers Lessons learnt from pilot studies in developing voluntary testing strategies to avoid unnecessary animal testing and costs were published in January 2021 and can be applied to future testing strategies.	For more information, visit the ECHA’s website here
17/03/2021	Mapping of the chemical universe progresses An updated list of mapped substances is now available on ECHA´s website. Registered substances are divided into five pools based on the regulatory actions in place, initiated or considered for them. The mapping will contribute to the annual report on ECHA’s Integrated Regulatory Strategy, which will be published in April. The aim is to have all registered substances screened and allocated to pools by 2027, indicating whether they are: A priority for regulatory risk management; A low priority for further regulatory action; or A priority for data generation. You can download the list of REACH registered substances divided in pools by clicking here.	For more information, visit the ECHA’s website here
09/03/2021	Substances of Very High Concern identification ECHA launched on 9^th March this year the first public consultation on eight proposals for potential Substances of Very High Concern (SVHC). Four of them are food contact chemicals (FCCs) including: bisphenol B, 1,4-dioxane, medium-chain chlorinated paraffins (MCCP), and phenol alkylation products with C12-rich branched or linear alkyl chains from oligomerization (PDDP). If the proposals are accepted and the substances are identified as an SVHC, they will be added to the Candidate List for eventual inclusion in the Authorisation List. The deadline for submitting comments is on 23^rd April.	For more information, visit the ECHA’s website here
10/03/2021	OECD publishes guidance on identifying chemical alternatives In March 2021, the Organization for Economic Co-operation and Development (OECD) published a guidance document on the identification and selection of safer chemical alternatives. This guidance aims to advance broader agreement on a general approach and criteria for the selection of safer alternatives, with a focus on chemical substitution and to determine that a chemical alternative is safer than the one it would substitute.	Guidance on Key Considerations for the Identification and Selection of Safer Chemical Alternatives can be consulted here
12/03/2021	ANSES proposes bisphenol B as REACH SVHC The French agency for food, environmental and Occcupational Health&Safety (ANSES) proposes listing bisphenol B as a substance of very high concern (SVHC) under REACH regulation and preventing the substitution of BPA. According to a review by ANSES, bisphenol B has similar or even more pronounced endocrine disrupting properties compared to bisphenol A which it is intended to replace. Public consultation was opened until 23^rd April 2021.	For more information, visit the ANSES website here
04/03/2021	Recommended occupational exposure limits for titanium dioxide nanoparticles Titanium dioxide in nanoparticle form or TiO2-NP is one of the most widely used nanomaterials in various industrial sectors in France. It is therefore a major source of potential exposure in the workplace. ANSES is now recommending an occupational exposure limit (8h-OEL) of 0.80 microgram per cubic metre. In addition, due to the lack of available data on the immediate or short-term effects of TiO₂-NP and in accordance with its methodological guide, ANSES also recommends not exceeding the concentration of 4 micrograms per cubic metre over a 15-minute period. Compliance with this value should help limit the size and number of exposure peaks over the working day.	For more information, visit the ANSES website here
12/03/2021	European Commission proposes a change on intermediate criteria under REACH regulation Intermediate substances are exempt from authorisation process and also require less data requirements for REACH registration. However, according to the 38^th meeting of Competent Authorities for REACH and CLP (CARACAL) that took place on 3^rd – 4^th March this year, the European Commission considered making changes to REACH on the definition of intermediate uses or to complement those criteria by more explicit provisions following the Judgment of the Court of Justice in case e C-650/15/P (“Acrylamide Judgment”). The preparatory work will include options to amend the legal text on intermediates according to Article 3(15) and the revision of the existing guidance.	Summary conclusions of the 38^th Meeting of Competent Authorities for REACH and CLP (CARACAL) can be consulted here
16/03/2021	Supporting Montenegro and Serbia to prepare for EU chemicals laws ECHA supports the accession countries to build capacity ahead of joining the EU. A study has assessed the gaps and needs of aligning to and implementing EU chemicals legislation such as REACH, CPL, BPR and PIC regulations in Montenegro and Serbia and proposes national action plans on how to move forward.	For more information, visit the ECHA’s website here

Other interesting links about REACH

Recent Updates regarding CLP

The below table 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
20/04/2021	Published the 16^th ATP of the CLP regulation (esto lo cambié despues de proof reading) Commission Delegated Regulation (EU) 2021/643 of 3 February 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Some notes set out in subsection 1.1.3 of Part 1 of Annex VI to CLP that generated a degree of uncertainty has been amended at the request of some Member States and stakeholders.	Commission Delegated Regulation (EU) 2021/643 can be viewed here
21/04/2021	Webinar on how to prepare a poison centre notification The questions and answers session from the poison centre notifications webinar that took place on March 31 is now published. You can also watch the recording and presentations. The webinar gave useful tips on how to prepare a poison centre notification, and is particularly helpful if you are new to dossier preparation, your dossier has failed the validation rules or you need to update your notification.	For more information, visit the ECHA’s website here
07/04/2021	Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation (Poison Centre Notification) In order to facilitate companies the notification process, ECHA has published a visual summary document that shows the status of each Member State.	Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation is available here
18/03/2021	EU proposes to update EU CLP Regulation to cover endocrine disruptors The European Commission is proposing that endocrine disrupting chemicals (EDCs) be classified under CLP as either ‘category 1: known or presumed’ or ‘category 2: suspected’ and to separate out human health endocrine disrupters from environmental ones. In addition, the definition of an endocrine disruptor is expected to be completed by the end of 2021. Expected concentration limits would be in line with current CMRs (≥0,1% for Category 1 and ≥1% for Category 2). The drafting proposal for revision of CLP is expected on September 2021 and its adoption by the Commission at the end of this year.	For more information, visit the ECHA’s website here
10/02/2021	ANSES proposes a classification under the CLP Regulation for the substance hexyl salicylate used in cosmetics, household cleaners and detergents The substance hexyl salicylate, used in cosmetics and household cleaners, can have various effects on health, ranging from allergic skin reactions to abnormal foetal development. In order to better inform and protect consumers, ANSES has submitted a classification proposal to the European Chemicals Agency (ECHA) under the CLP Regulation. If validated, this classification will have direct consequences on the labelling of products containing this substance at European level as follows: May cause an allergic skin reaction; Category 1 (H317)" "Suspected of damaging the unborn child; Category 2 (H361d)" The public consultation was open until 9^th April 2021. On the basis of the opinion issued on the classification of hexyl salicylate by the ECHA´s Committee for Risk Assessment, the European Commission will make its final decision.	For more information, visit the ANSES website here

Other interesting links about CLP

Regulations proposals

Please find below a table summarising recent regulation proposals made to the European Commission (Non-exhaustive):

Notification number	Countries	Title
2021/262/A	Austria	The legislative amendment transposes requirements from Directive (EU) 2019/904 into national law, specifically updating the Waste Management Act 2002, concerning packaging. In addition, requirements from the amended Directive 2008/98/EC are being transposed in relation to the extended producer responsibility regime for packaging.
2021/256/NL	Netherlands	In the Netherlands, objects made of gold, silver or platinum must bear a hallmark issued by a designated assay office that guarantees the fineness of the precious metal in question. The assay requirement and the rules for assaying and assay bodies (the designated assay offices) are contained in the Assay Act 2019 [Waarborgwet 2019] (previously notified under Notification No 2018/495/NL) and the Hallmarking Order 2019 [Waarborgregeling 2019] (previously notified under Notification No 2019/422/NL). However, the rules on composite objects contain two gaps. These concern mainly composite objects with a (extremely thin) precious metal top layer. The bill rectifies these two apparent gaps in the Assay Act 2019. This bill was previously notified (2020/347/NL), but is notified again due to some changes to the proposal.
2021/161/P	Portugal	This draft Decree-Law transposes into national law Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (SUP Directive).
2021/160/P	Portugal	This draft Decree-Law regulates Article 321 of Law No 75-B/2020 of 31 December on the 2021 State Budget Law. This draft legislation prohibits the placing on the market of cosmetic products, hygiene products, detergents and cleaning products containing plastic microspheres consisting of synthetic particles of less than 5 millimetres in diameter.

New UK authorities’ publications and updates

UK authorities have updated the following guidance, documents and corrigendum in relation to import, export and customs for businesses (non-exhaustive list):

Apply for authorisation for the UK Trader Scheme if you bring goods into Northern Ireland
Agreements reached between the United Kingdom of Great Britain and Northern Ireland and the European Union
Rules of origin for goods moving between the UK and EU
E-Alert relating to Legislation number: 2020 No.1647 - The Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020 SCHEDULE A1:
The concentration value of Cadmium, currently given as 0.1% instead of 0.01% in Schedule A1 of SI 2020 No.1647, is a typographical error.
A formal amendment to correct the error will be implemented shortly.
You should, therefore, continue to work to the 0.01% threshold for Cadmium under the RoHS Regulations.

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
28/10/2021	Downstream user import notification (DUIN) 28/10/2021: Deadline to submit a notification to the Agency regarding the substances you wish to continue importing into the GB from the EU. It should be noted that, having notified under Article 127E, you are not obliged to register unless you wish to continue importing the notified substance after 300 days plus either two (28/10/2023), four (28/10/2025) or six (28/10/2027) years of the end of the transition period. This only needs to be done once per legal entity and covers all substances that you wish to continue importing from the EU.	For more information visit HSE´s website
01/04/2021	Following public consultation, HSE published the statement from UK REACH Agency on the use of independent scientific knowledge and advice (ISA)	For more information visit HSE´s website
31/03/2021	Questions and answers for companies In this Q&A section, you can find detailed advice on the impact of the UK’s withdrawal from the EU on the chemical legislations managed by ECHA i.e. REACH, CLP, BPR, PIC and POPs. There is also a section on Northern Ireland where these regulations continue to apply.	For more information visit ECHA´s website
23/03/2021	Restrictions under UK REACH for first time Government has laid out plans for restriction work that will be carried out in the first year of UK REACH. The UK REACH programme includes plans to initiate the restriction process on lead ammunition widely used in the shooting industry, harmful substances in tattoo inks and permanent make-up and per- and polyfluoroalkyl substances (PFAS).	For more information visit GOV.UK website
19/03/2021	Submitting chemicals information to the National Poison Information Service (NPIS) On 1 January 2021, the GB CLP Regulation came into force. GB-based importers and downstream users, and NI-based downstream users directly supplying the GB market with qualifying Northern Ireland goods, are encouraged to voluntarily submit information relating to emergency health response, and preventative measures on hazardous mixtures placed on the GB market, to NPIS using a safety data sheet (SDS).	For more information visit HSE´s website

TPCH adopts the updates model legislation for packaging

Last June, the Toxics in Packaging Clearinghouse (TPCH) proposed to update their Toxics in Packaging Model Legislation, mainly including the addition of PFAS and phthalates as regulated chemicals. And this proposal has come into effect in February 2021.

This newly updated Model Toxics in Packaging Legislation covers following major changes:

ortho-pthalates may not be present exceed 100 ppm in any package or packaging components;
PFAS may not be present above the detection limit in any package or packaging components;

The previous TPCH Model legislation was enacted in 19 states prohibiting the total incidental concentration of the four heavy metals (cadmium, lead, mercury, and hexavalent chromium) above 100 ppm. But it will be up to each state whether to adopt this updated legislation to their existing laws or to adopt a new law to address toxics in packaging no later than two years after this enactment.

Details can be found here.

California Proposition 65 Reformulations

California Proposition 65 is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, which has been effective for almost 30 years. Due to the implement of California Proposition 65, more and more court cases are settled to reduce the exposure of carcinogenic and reproductive chemicals by reformulating the consumer products containing such chemicals.

In order to keep retailers and manufacturers up-to-date, the highlights of the consent agreement are summarised as below:

Product	Chemical	Limit	Case No
Rain gauges with exterior decorations	Lead	100ppm 1.0ug	Out of court
Apple watch protectors/bumpers iPad case	BPA	Not exceed 3 µg per day of dermal exposure from solid materials	Out of court
Duck calls	BPA	Not exceed 3 µg per day of dermal exposure from solid materials	Out of court
Mobile Phone cases	BPA	BPA-Free	Out of court
Sandals/flats	DEHP, DBP, BBP, DINP, DIDP, DnHP	1,000 ppm of each	Out of court
Hammer	Lead	90ppm 1.0ug	Out of court
Squeegee Item	Lead DBP, DEHP and DINP	100ppm of lead 1000ppm each of DBP, DEHP and DINP	Out of court

New requirements for packaging and packaging components

In February 2021, the Model Toxics in Packaging Legislation was updated by the Toxics in Packaging Clearinghouse (TPCH).

This Legislation was developed in 1989 to reduce the amount of heavy metals in packaging and packaging components. TPCH Model Legislation prohibit the intentional use of lead, cadmium, mercury and chromium (VI) in any finished package or packaging component, as well as limiting, the total incidental concentration to 100 parts per million by weight (0.01%). This legislation was adopted by nineteen states: California, Connecticut, Florida, Georgia, Illinois, Iowa, Maine, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.

The main changes are as follows:

The sum of the concentration levels of phthalates should not exceed 100 parts per million by weight (0.01%).
Prohibition of sale or distribution of a package or packaging components containing PFAS.
Criteria for the identification and prohibition of packaging chemicals of high concern

This legislation shall become effective immediately upon adoption.

To read the official news, visit the TPCH’s website here.

Toxic-Free Kids Act: Implementation of Phase 3

On 1^st March 2021, the Oregon Health Authority published Phase 3 of the Toxic-Free Kids Act which requires manufacturers of children's products sold in Oregon to report products that contain one or more high priority chemicals of concern for children's health (HPCCCH), and ultimately remove these chemicals, look for an alternative to make the product less hazardous or seek a waiver approved by the Authority.

This Phase indicates detailed requirements for manufacturers of three specific categories of children's products:

Children under three years old;
"Mouthable" items, per ORS 431A.253(8); and
Children's cosmetics.

To read the HPCCCH list, visit the Oregon Health Authority website here.

Proposal and addition of substances in Proposition 65

On 19^th March 2021, The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) noticed the state of the following substances:

The intention to list perfluorooctanoic acid (PFOA) (CAS RN 335-67-1) as known to the State of California to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
The addition of molybdenum trioxide (CAS No. 1313-27-5) and indium tin oxide (CAS No. 50926-11-9) to the list of chemicals known to the State of California to cause cancer for purposes of Proposition 65. The listing of these chemicals is pursuant to the “Labor Code” listing mechanism.

For more information, visit the OEHHA website here.

No Action Assurance for flame retardant PIP (3:1)

In March 2021, The US Environmental Protection Agency (EPA) announced a 60-day public comment period to collect additional input on five final rules for persistent, bioaccumulative and toxic (PBT) chemicals issued on 6^th January 2021 under the Toxic Substances Control Act (TSCA).

On 8^th March 2021, EPA is issuing a temporary 180-day “No Action Assurance” for prohibition of flame retardant PIP (3:1) because of received comments, for example from the electronics and electrical manufacturing industry. PIP (3:1) is used as a flame retardant and a plasticizer in plastic components such as PVC wire covers and casings which can be found such as in gaming consoles.

For more information, visit the EPA website here.

Canada

Draft guidance document for the notification and testing of new chemicals and polymers

The draft guidance is now available for use and comments until 30^th June 2021. Comments can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window or by email to eccc.substances.eccc@canada.ca. When finalised, this new guidance document will replace the 2005 Guidelines for the notification and testing of new substances – chemicals and polymers prepared to assist notifiers responsible for complying with the New Substances Notification Regulations (Chemicals and Polymers) (the Regulations) of the Canadian Environmental Protection Act, 1999 (the Act).

This new guidance document will provide assistance for complying with regulatory requirements, including step-by-step instructions for the completion of a New Substances Notification.

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/EU/797	Europe	This draft Commission Regulation aims to include within the scope of entries 28 to 30 of Annex XVII to REACH regulation several substances, with the effect of restricting their placing on the market or use for supply to the general public as substances on their own, as constituents of other substances or in mixtures and to impose the requirement to mark packaging with the label "restricted to professional users".
G/TBT/N/PER/129	Peru	The notified draft Technical Regulation establishes the technical and labelling requirements for biodegradable plastic bags in order to ensure that, as part of a circular economy model, no microplastic pollution or hazardous substances are produced as a result of their degradation.
G/TBT/N/MAC/17	Macao	Prohibition of import, export and transit of mercury and amalgam listed in The Minamata Convention on Mercury and contained in the Schedule annexed to Chief Executive's Decision No. 231/2020 in the Macao Special Administrative Region.
G/TBT/N/BRA/1151	Brazil	In March 2021, the Brazilian Ministry of Economy/National Institute of Metrology, Quality and Technology published INMETRO Ordinance No. 123 of February 16, 2021 (Portaria Inmetro No. 123, de 16 de Fevereiro de 2021) as the approved consolidated Technical Regulation for Jewelry and costume jewelry (Consolidated Technical Regulation).
G/TBT/N/EGY/288	Egypt	The Ministerial Decree No. 610/2020 mandating the Egyptian Standard ES 8398 "Safety data sheet for chemical products — Content and order of sections"
G/TBT/N/KOR/944	Korea	A draft revision of safety criteria for children's product

Product Recalls / Alerts

Below you will find a bimonthly summary table of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”)

Europe

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

The following alerts for chemical risks regarding different type of products have been reported, from week 8 to week 14 of 2021:

Chemical risks
Number of alerts	Notes
2	Childcare articles Mattress for babies and toodlers (Childcare): It contains dimethylformamide. It does not comply with REACH Regulation. Silicone corner protector: It contains short chain chlorinated paraffins (SCCPs) and an excessive amount of bis(2-ethylhexyl) phthalate (DEHP) and diisobutyl phthalate (DIBP). It does not comply with REACH Regulation and with POP Regulation.
3	Clothing, textiles and fashion items Leather gloves and sandals: they contain chromium VI. It does not comply with REACH regulation.
2	Construction products Black rubber mats for lawns and fall protection plate: The product contains an excessive amount of polycyclic aromatic hydrocarbons (PAH)s. The product does not comply with REACH regulation.
65	Jewellery Earrings, necklaces, hair accessories: The product contains excessive amounts of cadmium and of lead. It does not comply with REACH regulation. Earrings, necklaces, hair accessories: The product contains excessive amounts of nickel. It does not comply with REACH regulation.
	Stationary Thermal paper: The product contains excessive amounts of bisphenol A. It does not comply with REACH regulation.
20	Plastic toy: Article contains bis (2-ethylhexyl) phthalate (DEHP) and diisobutyl phthalate (DIBP), diisononyl phthalate (DINP). Does not comply with the REACH Regulation.
	Balloons: The amount of N-nitrosatable and nitrosatable substances generating n-nitrosodimethylamine (NDMA) substances released by the balloons is too high. It does not comply with the Toy Safety Directive and EN 71-12.
	Car toy: The soldered joints of the toy contain an excessive amount of lead. It does not comply with RoHS Directive.
	Jumpbag with foam: The foam material in the product contains an excessive amount of the flame retardant tris(2-chloro-1-methylethyl) phosphate (TCPP). It does not comply with the Toy Safety Directive.
	Toy slime: The migration of boron from the toy slime is too high. It does not comply with the REACH Regulation and the Toy Safety Directive and EN 71-3.

Between the 21^st February and 20^th April 2021, CPSC (Consumer Product Safety Commission) published the following recalls regarding chemical risks: 0 recall.

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Cosmetics & Personal Care

Check the compliance and safety of your products containing UV filters

Sunscreen is designed to protect your skin from the sun's damaging rays, and forms an important part of a complete sun protection strategy. UV filters, mainly used in sunscreen products and some other cosmetics and personal care products, play an important role in maintaining good health and are regularly subjected to specific verifications by scientific committees to ensure their safety and efficacy.

CENELEC / CEN
Reference	Title	*Date of Withdrawal ()**	Supersedes
EN 14387:2021	Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking	2021-08-31	EN 14387:2004 +A1:2008
EN 143:2021	Respiratory protective devices - Particle filters - Requirements, testing, marking	2021-08-31	EN 143:2000/ AC:2005 EN 143:2000/ AC:2002 EN 143:2000/ A1:2006 EN 143:2000
EN ISO 19734:2021	Eye and face protection - Guidance on selection, use and maintenance (ISO 19734:2021)	2021-09-30

Type of Risk	Number of alerts	Notes
Health risk/ other	3	Particle filter mask It advertises a protective potential against particles, but its filtering capacity has not been tested by a relevant competent European conformity assessment body. It does not comply with the Personal Protective Equipment Regulation.
	1	Particle filter mask The product bears a CE marking but is not certified as protective equipment by a relevant body. The labeling is confusing because on the cardboard box the mask is declared to be “non-medical” , but also claims to meet EN 14683: 2019.
	3	Particle filter mask The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified by the relevant (European) body.
	1	Particle filter mask The product advertises a protective potential against particles but its filtering capacity has not been tested by a relevant competent European conformity assessment body, and it misuses the CE marking and the model name of a different product from the same manufacturer, which is certified. The packaging of the two being identical, there is no possibility for the consumer to see that it is not the certified product.
	6	Particle filter mask The particle/filter retention of the material is insufficient (measured values too low).
	1	Particle filter mask The mask is presented as providing a protective function, however these claims are not backed by evidence. This could create a false sense of safety to the wearer of the mask and thus, even if combined with other recommended measures, not protect its user.