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Chemicals | Monthly bulletin | June 2022

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Europe

 

Draft restriction for formaldehyde and formaldehyde releasing substances in articles

 

On 2nd May 2022, the World Trade Organization (WTO) published Draft European Commission Regulation Amending Annex XVII to Regulation (EC) No 1907/2006 as regards formaldehyde and formaldehyde releasers.

 

This proposed restriction aims to decrease exposure to formaldehyde via inhalation in indoor air, including inside road vehicles.

 

The restriction for articles where formaldehyde or formaldehyde releasing substances have been intentionally added in production is:

 

Articles

If concentration of formaldehyde released exceeds

Wood-based articles and furniture

0.062 mg/m3

Other articles

0.08 mg/m3

Road vehicle

0,062 mg/m3

 

For more information, consult the WTO publication here.

 

Recent updates regarding REACH

 

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

 

Summary of the Most Recent Updates

Date

Subject

Link

25/03/2022

European Commission published COMMISSION REGULATION (EU) 2022/477 which amends the Annexes VI to X to REACH Regulation (EC) No 1907/2006.

The main point is that only representatives must identify the non-EU manufacturers they represent and provide their contact information by 14 October 2022.

The official publication in European Commission website here.

25/04/2022

Publication of COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability, which is an important step forward in providing detailed information on all ongoing work on future restrictions under the EU's chemical legislation REACH. 

The official publication in European Commission website here.

04/05/2022

Updated ECHA Guidance on harmonised information relating to emergency health response – Annex VIII to CLP (version 5.0)

For more information, consult the ECHA guidance here.

11/05/2022

SCIP manuals: Translations available in 23 EU languages. When preparing a SCIP notification, these manuals will help you protect your data and  refer to already submitted data.

For more information, consult the ECHA manual here.

11/05/2022

ECHA's Bisphenols Assessment Group studied 148 compounds and recommended the restriction of more than 30 due to their potential harm to human health and the environment. The evaluation grouped structurally similar substances based on the presence of "bisphenol" in their compositions, reviewing a total of 148.

For more information about the restriction proposal, consult the Assessment here.

 

Other interesting links about REACH from the ECHA’s website

 

 

Update in Annex VI to Regulation (EC) No 1272/2008 (CLP)

 

On 3rd May 2022, the European Commission published the following amendment related to CLP:

 

COMMISSION DELEGATED REGULATION (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

 

The main points which affect Part 3, table 3 of Annex VI of CLP Regulation are:

 

  • 39 new entries are inserted.
  • 17 entries have been revised and replaced (index numbers: 014-001-00-9; 023-001-00-8; 601-024-00-X; 603-014-00-0; 603-107-00-6; 604-030-00-0; 607-111-00-9; 607-230-00-6; 607-253-00-1; 607-254-00-7; 607-734-00-6; 607-735-00-1; 607-736-00-7; 608-032-00-2; 609-042-00-X; 613-012-00-1; 616-164-00-7).
  • The entry corresponding to index number 615-007-00-X has been deleted.

 

Other interesting links about CLP from the ECHA’s website

 

 

Public Initiatives related to chemicals, POP and RoHs

 

The below table includes some recent publications related to Chemicals POPs and RoHs:

 

Status

Category

Publication

In preparation

Chemicals

Chemical safety – better access to chemicals data for safety assessments

The initiative will make it easier to access and use all available data and will increase transparency. It will also enable EU and national authorities, where necessary, to commission testing and monitoring of chemical substances as part of the regulatory framework.

Draft act

Feedback period

17 May 2022 - 14 June 2022

POP

Persistent organic pollutants (POPs)- perfluoroctanoic acid (PFOA)

This act concerns PFOA, its salts, and PFOA-related compounds (included in Annex I of Regulation (EU) 2019/1021). It amends the PFOA concentration as an unintentional trace contaminant in substances, mixtures and articles, and removes a specific exemption that is no longer needed in the EU.

In preparation

RoHs

Hazardous substances in electrical and electronic equipment – list of restricted substances (update)

The Commission regularly reviews the list of restricted substances to keep up with technical progress, protect human health and the environment, and improve waste management. Following a technical assessment, this initiative proposes adding tetrabromobisphenol A (TBBP-A) and medium-chain chlorinated paraffins (MCCPs) to the list of restricted substances.

In preparation

RoHs

Hazardous substances in electrical and electronic equipment – exemption for cadmium in quantum dots for LED applications

The Commission has assessed three exemption requests on the use of cadmium in quantum dots in LED lighting and displays. This initiative proposes amending the list of restricted substances in Annex III to Directive 2011/65/EU.

 

Technical and Official publications about detergents and FCM

 

The below table includes some recent publications related to detergents and food contact materials (FCM):

 

Entity

Date

Publication

Ministero della Salute

(Italy)

21/04/2022

The Istisan Report on the Surveillance of Exposures to Detergents has been published, produced by the Higher Institute of Health (CNSC - National Center for Chemicals, Cosmetic Products and Consumer Protection), in collaboration with the Ministry of Health and the Poison Control Centers (CAV) of Bergamo and Foggia.

The report analyses exposures to detergents and related products collected by the Poison Control Centers in  the period 2016-2020.

EFSA ( European Food Safety Authority)

12/05/2022

Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food

EFSA ( European Food Safety Authority)

12/05/2022

Protocol for the exposure assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food.

 

France

 

Updated Environmental code in relation to hazardous substances in electrical and electronic equipment

 

On 4th May 2022, the French authorities published the Order of May 4, 2022 amending the order of March 5, 2020 regarding the limitation of the use of certain hazardous substances in electrical and electronic equipment.

 

The aim is to update the Environment Code, in relation to the modifications made by the European Commission to Annex III of Directive 2011/65/EU on the limitation of the use of certain hazardous substances in electrical and electronic equipment. In the 31st line of Table 1 of the Annex to the order of March 5, 2020, the following twelve new lines are added:

 

As of

Delegated Directive (EU)

Modification

01/10/2022

2022/274 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU as regards an exemption for the use of mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps for special purposes.

01/10/2022

2022/275 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in other high-pressure sodium vapor lamps for general lighting purposes.

01/10/2022

2022/276 of the Commission, of December 13, 2021

Annex III of Directive 2011/65/EU on an exemption for the use of mercury in single-ended (compact) fluorescent lamps for general lighting purposes.

01/10/2022

2022/277 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU as it refers to an exemption for the use of mercury in single-ended (compact) fluorescent lamps, for general lighting, of less than 30 W and with a useful life equal to or greater than 20,000 hours.

01/10/2022

2022/278 of the Commission, of December 13, 2021

Annex III of Directive 2011/65/EU on an exemption for the use of mercury in metal halide lamps.

01/10/2022

2022/279 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in other discharge lamps for special purposes.

01/10/2022

2022/280 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in other low pressure discharge lamps.

01/10/2022

2022/281 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in single-ended (compact) fluorescent lamps for special purposes.

01/10/2022

2022/282 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in non-linear triphosphor lamps.

01/10/2022

2022/283 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU as it refers to an exemption for the use of mercury in high-pressure sodium vapor lamps that have an improved color rendering index intended for general lighting use.

01/10/2022

2022/284 of the Commission, of December 16, 2021

Annex III of the Directive 2011/65/EU on an exemption for the use of mercury in two-ended linear fluorescent lamps for general lighting purposes.

01/10/2022

2022/287 of the Commission, of December 13, 2021

Annex III of the Directive 2011/65/EU of the European Parliament and of the Council on an exemption for mercury in fluorescent lamps for other general lighting and special purposes.

 

UK

 

Recent updates regarding UK REACH and GB CLP

 

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

 

Summary of the Most Recent Updates

Date

Subject

Link

20/05/2022

Updating the GB mandatory classification and labelling list (GB MCL List)

HSE GB CLP publication table  can be consulted here.

 

Switzerland

 

Closer to European chemicals legislation

 

On 1st April 2022, Ordinance on the reduction of risks associated with the use of particularly dangerous substances, preparations and objects (RO 2022 162 - FR, DE, IT) came into force which revised the Chemical Risk Reduction Ordinance, ORRChem, RS 814.81 (FR, DE, IT) and aligned it with Regulation (EU) 2019/1021 on persistent organic pollutants (POP recast regulation) and Annex XVII of Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH) in the European Union (EU)’.

 

The main changes are:

 

  • Annex 1.1 ‘Persistent organic pollutants, POP’
  • Annex 1.16 ‘Per- and polyfluoroalkyl substances, PFAS’
  • Annex 1.2 ’Halogenated organic substances’
  • Annex 1.4 ‘Ozone depleting substances’
  • Annex 1.5 ‘Substances stable in the atmosphere’
  • Annex 1.6 ‘Asbestos’
  • Annex 1.10 ‘Carcinogenic, mutagenic or reprotoxic substances, CMR substances’
  • Annex 2.9 ‘Plastics, their monomers and additives’
  • Annex 2.10 ‘Refrigerants’
  • Annex 2.11 ‘Extinguishing agents’

Other relevant effective dates which are compiled in this Ordinance are:

 

  • On 1st October 2022, Annex 1.16
  • On 1st April 2023, phytosanitary products (Art. 61, s.4 and 5).

Note: For more information, please consult the official publication on Swiss chemical Ordinances below:

 

  • The Chemicals Ordinance (ChemO 813.11) (FR, DE, IT)

 

US

 

New Hampshire Introduces PFAS Warning Label Bill

 

On March 15th, 2022, the State of New Hampshire introduced HB 1422, titled “Requiring warning labels on consumer products containing perfluorinated chemicals.” Under the proposed bill, manufacturers, producers, packagers, importers, suppliers, or distributors of a PFAS-containing consumer product or packaging shall do one of the following:

 

  • Beginning January 1st, 2024, provide warning labels on products or packaging, stating that it contains PFAS and that exposure to PFAS may have adverse health effects.
  • By January 1st, 2024, and annually thereafter, provide a written notice directly to the authorised agent for a retail seller and obtain written confirmation of receipt of the notice. The notice shall meet:
    • State that the product or the packaging may result in exposure to PFAS, an organic chemical containing at least one fully fluorinated carbon atom;
    • Include the exact name or description of the product or specific identifying information for the product, such as an universal product code; and
    • Be accompanied by labels or labeling that meet the requirements of section 5 of the regulation and, for a product to be sold by the retailer on the internet, warning language that meets the requirements of Section 5.

 

Maryland Enacts New PFAS in Products Law

 

On April 21st, 2022, the State of Maryland approved SB 273, Chapter 139, an Act concerning “Environment – PFAS Chemicals – Prohibitions and Requirements.” Effective January 1st, 2024, the new law will prohibit intentionally added PFAS chemicals in the following products:

 

  • Class B fire-fighting foam;
  • Rugs and carpets;
  • Food packages that are composed of paper, paperboards or other materials originally derived from plant fibers; and
  • Plastic disposable gloves used in commercial or institutional food service.


PFAS chemicals are defined as a class of fluorinated organic chemicals that contain at least one fully fluorinated carbon atom, including perfluoroalkyl and polyfluoroalkyl substances and are designed to be fully functional in Class B fire-fighting foam formulations.

 

Please see the table  below for a summary of the new PFAS law.

 

Substance

Product Category

Requirement

Remarks

Effective Date

PFAS

Class B fire-fighting foam

Prohibited

  • Use in airports, ports, refineries, or chemical plants exempted until September 30th, 2024
  • Use in terminals exempted until December 31st, 2027
  • Use by a person that is required to use a foam that contains intentionally added PFAS chemicals exempted until any applicable date specified by federal law

January 1st, 2024

Rugs and Carpets

Prohibited

  • Must establish a certificate of compliance to attest compliance
  • Used rugs are exempt

January 1st, 2024

Food packages that are composed of paper, paperboards or other materials originally derived from plant fibers

Prohibited

  • Must establish a certificate of compliance to attest compliance

January 1st, 2024

Plastic disposable gloves used in commercial or institutional food service

Prohibited

  • Must establish a certificate of compliance to attest compliance

January 1st, 2024

 

Washington to Ban PFAS in 5 Additional Types of Food Packaging

 

Under RCW 70A.222.070, the State of Washington restricted the manufacture, distribution, and sale of food packaging to which per- and polyfluoroalkyl substances (PFAS) have been intentionally added in any amount if safer alternatives to PFAS in food packaging are identified. As required under RCW 70A.222.070, in 2021, the Washington State Department of Ecology conducted an alternatives assessment and filed a first report to the legislature with findings of safer alternatives for four food packaging applications (Wraps and liners, plates, food boats, and pizza boxes). The prohibition against the sale of the specified PFAS-containing food packaging applications from the first report will take place in February 2023, two years from the date the report was submitted to the legislature.

 

In May 2022, the Washington State Department of Ecology released a second report to the legislature  with findings of safer alternatives for five additional food packaging applications (bags and sleeves, bowls, flat serviceware, open-top containers, and closed containers). The prohibition against manufacturing, sale, and distribution of PFAS-containing food packaging in these five food packaging applications will take effect two years from the date of submission of the second report to the legislature in May 2024.

 

Canada

 

Canada Proposes Prohibition of Certain Toxic Substances Regulations, 2022

 

On May 14th, 2022, Canada published in the Canada Gazette the proposed Prohibition of Certain Toxic Substances Regulations, 2022 (the “proposed Regulations”). The proposed Regulations would repeal and replace the Prohibition of Certain Toxic Substances Regulations, 2012 (the “current Regulations”), which prohibits the use, sale, offer for sale and import of certain toxic substances. The proposed Regulations would further restrict the following five substances, which are regulated under the current Regulations, by removing exemptions, or by imposing conditions on the remaining exemptions:

 

  1. Perfluorooctane sulfonate (PFOS), its salts and its precursors;
  2. Perfluorooctanoic acid, its salts, and its precursors (PFOA);
  3. Long-chain perfluorocarboxylic acids, their salts, and their precursors (LC-PFCAs);
  4. Hexabromocyclododecane (HBCD); and
  5. Polybrominated diphenyl ethers (PBDEs).

The proposed regulations also includes concentration thresholds for these substances at or below which their presence would be considered incidental, and thus the prohibition would not apply.  Please see Table 1 below for the concentration thresholds of each substance.

 

Table 1:

 

Substance

Concentration Threshold

PFOS

1 ppm

PFOA

1 ppm

LC-PFCAs

1 ppm

HBCD

100 ppm

PBDEs

  • 10 ppm for the presence of each PBDE congener (e.g. decaBDE, pentabromodiphenyl ethers) in a substance, mixture, polymer or resin;
  • 500 ppm for the presence of PBDE congeners in all other products.

 

The proposed regulations also introduce new restrictions on the following substances, with some exemptions:

 

  1. Dechlorane Plus (DP); and
  2. Decabromodiphenyl ethane (DBDPE).

 

Australia

 

Australian industrial chemicals

 

In April, the Australian Government – AICIS published the following updates related to chemicals:

 

Date

Tittle

29/04/2022

Updated record-keeping checklists for exempted and reported introductions

28/04/2022

New AICIS registered businesses search (beta) available