Eurofins | August 2019 regulatory Newsflash compilation | Chemicals

Europe

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

On 16^th July 2019, the ECHA (European Chemicals Agency) has released the new Candidate List of SVHCs.

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Recast of Regulation on Persistent Organic Pollutants

On 25^th June 2019, a Recast of the Regulation on persistent organic pollutants (POPs) was published in the Official Journal of the European Union.

“Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (Recast)”

This new Regulation entered into force on July 15^th 2019 and repeals the previous POP Regulation (EC) No 850/2004 and all its amendments.

The aim of this Recast is to give more clarity (the previous POP Regulation was modified 12 times) while ensuring an efficient implementation of legislation on chemicals and alignment with other relevant laws of the European Union, such as REACH and the latest amendments to the Stockholm Convention, which provides the global legal framework for the elimination of production, import and export of persistent organic pollutants.

Same as for REACH, CLP, BPR and PIC Regulations, now the European Chemicals Agency (ECHA) will also be responsible for the administrative, technical and scientific aspects of POP Recast Regulation.

This new regulation has toughened the requirements applicable to persistent organic pollutants and includes important changes to terminology to encourage consistency with REACH Regulation. Hence, the definitions for substances, mixtures (former “preparation”) and articles have been aligned with REACH.

In addition, “Unintentional Trace Contaminant”, also known as UTC, is now defined as the “level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods”.

Some relevant updates of POP Recast Regulation are summarized in Table 1 below (non-exhaustive list):

Table 1. Main updates of POP Recast Regulation.

For more information click here.

It has to be noted that, according to a guidance document issued by the European Commission regarding the relationship between REACH and the Stockholm Convention and POP Regulation:

“... Annex XVII to REACH already contains a restriction in relation to a substance which is subsequently listed under the POP Convention:

In these circumstances, the practice is to implement the listing in the POP Convention by means of amending the appropriate Annex(es) to the POP Regulation and to remove the restriction from Annex XVII to REACH (examples of this are PFOS, SCCPs and Penta-DBE).

 

Article 131 of REACH provides the enabling power for the Commission Regulation amending Annex XVII.

 

The entry in the appropriate Annex to the POP Regulation should cover at least the bans under the Stockholm Convention and existing restrictions in Annex XVII to the REACH Regulation.”

Based on the above, it is, therefore, expected that decaBDE and PCP (newly added to POP Regulation Recast) would be removed from Annex XVII to REACH Regulation.

Recent publications by European Commission

Below you will find some documents recently published in the Official Journal of the European Union.

Draft texts notified to the European Commission

The following draft document has been recently notified to the European Commission:

Additional Recent Updates Regarding REACH

Below table includes a summary of the main recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

Recent Updates Regarding CLP

Below table includes a summary of the main recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

Safety assessment of titanium dioxide for food contact materials

On 26^th June 2019, the European Food Safety Authority (EFSA) published the scientific opinion: “Safety assessment of the substance, titanium dioxide surface treated with fluoride‐modified alumina, for use in food contact materials”.

The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers should be limited. The Panel emphasizes that the existing specific migration limits for aluminium and fluoride should not be exceeded in any case.

Click here for getting the safety assessment by EFSA.

US

Regulatory proposals notified to WTO

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

US | Alaska

Anchorage, Alaska Approves Flame Retardant Ban

Anchorage Assembly unanimously passed Assembly Ordinance 2019-15(S), an ordinance that amends the Anchorage Municipal Code to add a new Chapter 15.100 and a new section which prohibits certain consumer products containing flame retardant chemicals.

Beginning from 1^st  January 2020, no person shall manufacture, sell or distribute any upholstered or reupholstered furniture and juvenile products that contain, or a constituent component of which contain banned flame retardant chemicals exceeding 1,000 parts per million within the municipality including:

• Halogenated, organophosphorus, organonitrogen, or nanoscale flame retardant chemicals
• Penta or octa mixtures of polybrominated diphenyl ethers, the deca mixture of polybrominated diphenyl ethers (PBDEs), or decabromodiphenyl ether (decaBDE)
• Antimony
• Chemical listed as 'designated chemicals' under Section 105440 of the Health and Safety Code
• Chemical covered in the Washington’s list of Chemicals of High Concern to Children

The following are not covered by this prohibition:

• Used or second-hand products
• Child restraint systems under 49 CFR 571
• Electronic products, electronic components of upholstered or reupholstered furniture or juvenile products and any associated casing for those electronic products
• Children's toys and clothing

Click here for the details.

US | Rhode Island

Rhode Island Increases Flame Retardants Levels in Upholstered Bedding and Furniture

On July 8, 2019, Rhode Island’s flame retardant Bill H 5119 (“An Act relating to health and safety- upholstered furniture and child products safety”) was signed into law by increasing the maximum amount of any non-polymeric organohalogen flame retardant chemical contained in residential upholstered bedding and furniture manufactured or sold in state from 100 ppm to 1,000 ppm.

Non-polymeric organohalogen flame retardant chemical includes any bromine or chlorine bonded to carbon chemical which is added to a plastic, foam, fabric, or textile. Following are exemptions from this rule:

• Internal electric and electronic components of residential upholstered furniture
• Bedding or residential furniture or bedding sold for use in commercial or public spaces

This act will come into force on 1^st January 2020. The prohibition of unsafe children’s products will also apply from 1^st January 2020. Products sold or in use prior to this date are not subject to this ban.

Click here for more information.

US | California

California Proposition 65 Reformulations (July, 2019)

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 some recent consent agreements are summarized as below:

US | Vermont

Vermont Passes Children’s Products Reporting Rule Amendment

On 19th June 2019, Vermont governor signed Bill S.55 into law which amends the existing Chemicals of High Concern (CHCC) reporting rule.

CHCC reporting rule requires manufacturers of children’s products to report to the Vermont Department of Health if their product contains CHCC above the threshold from 1 January 2017. Following points are the major amendment of Act 188:

• Manufacturers of children’s products containing a CHCC now shall provide notice to the Department of Health annually instead of biennially. The next reporting deadline will be due by 31st August 2020
• Manufacturers of children’s products containing a CHCC now shall report the brand name, the product model, and the universal product code if the product has such a code

This amendment came into effect on 1^st July 2019.

Document (PDF): [Vermont S. 55] in English.

Click here to access Health Vermont website.

Canada

Proposal of Formaldehyde Emissions from Composite Wood Products Regulations

On 29^th June 2019, Canada published proposed Regulations for Formaldehyde Emissions from Composite Wood Products for indoor use which would align with similar requirements in the United States.

The proposed Regulations would establish the following maximum emission levels for formaldehyde emissions from composite wood products, the same limits as those in the U.S. regulations:

• 0.05 parts per million (ppm) for hardwood plywood
• 0.09 ppm for particleboard
• 0.11 ppm for medium-density fibreboard
• 0.13 ppm for thin medium-density fibreboard
• 0.05 ppm for laminated products

Non-exempted composite wood products sold in, offered for sale in or imported into Canada, must be tested to ensure that they meet the above emission limits and are labelled as meeting the requirements.

This proposal would come into force six months after publication of the final Regulations in the Canada Gazette, Part II.

Click here for more information.