🚀 Released on 29th July 2022
The following 20-minute video explains what types of materials and parts can contain the new declarable substances and how to update your Regulatory Compliance Declarations (RCDs) and Packaging Compliance Statement.
A quick reference guide to help you update your declarations is also available:
- 1 new REACH Candidate List substance not normally found in concentrations > 0.1% w/w in supplied articles
- 7 new Proposition 65 substances:
- 2 substances not normally found in supplied articles
- 1 substance already included in BOMcheck
- 4 substances that can be found in supplied articles
- 2 new Swiss ORRChem substances under other legislation
- 1 new single-use plastic packaging restriction for oxo-degradable plastic
- 2 new French Mineral Oil Restriction substances in both RCD/FMD tools and the Packaging Compliance Statement
Resources (XML & CSV)
New REACH Candidate List substance
On 10 June 2022, the European Chemicals Agency added one new substance to the REACH Candidate List which now contains 224 substances.
- N-(hydroxymethyl)acrylamide (NMA) CAS: 924-42-5
BOMcheck will automatically update your Regulatory Compliance Declarations for this new substance as this substance is not normally found in concentrations > 0.1% w/w in supplied articles.
New Proposition 65 substances
On 17, 24, 31 December 2021 and 25 February 2022, OHHEA added 7 substances to Proposition 65. 2 out of 7 of these substances cannot be found in supplied articles and do not require notification:
- 2-Ethylhexyl acrylate (2-EHA)
- Trimethylolpropane triacrylate (TMPTA), technical grade
1 out of 7 of these substances is already included on the Proposition 65 list and the Other legislation list in BOMcheck:
- Perfluorooctanoic acid (PFOA)
A new listing for this substance was added by OHHEA to also include Cancer under the type of toxicity. As such, no new additional declaration is required in BOMcheck for this substance.
The following 4 out of 7 new substances can be found in supplied articles and may require notification:
|Substance||Likely to be found in supplied articles?|
|Perfluorononanoic acid (PFNA) and its salts||Yes - exposure to this substance is possible via PVDF plastic, commonly used in applications such as electrical wire insulation, piping, coatings and films|
|Perfluorooctane sulfonic acid (PFOS) and its salts and transformation and degradation precursors||Yes - exposure to this substance is possible via any products with water, oil and grease-resistant coatings or adhesives that could potentially contain PFOS|
|Methyl acrylate (MA)||Yes - exposure to this substance is possible as although Methyl Acrylate is reacted during the manufacturing process some residual monomer will remain|
|Tetrahydrofuran (THF)||Yes – exposure to this substance is possible. Evidence provided from one manufacturer states that THF is present in granules of neat resins. They emphasised that THF is always formed when the PBT-resin is molten. The formation of THF cannot be avoided when using PBT, regardless of the production process for the resin or other heat applying subsequent processing steps.|
New restriction on PFHxS and C9-C14 PFCAs
In April 2022, the Chemical Risk Reduction Ordinance (ORRChem) in Switzerland was updated to include new restrictions on PFHxS and C9-C14 PFCAs. From 1st October 2022, the maximum concentrations of these substances in articles are restricted to:
- PFHxS its salts and related substances at 25 ppb (sum of related substances at 1000 ppb)
- C9-C14 PFCAs their salts and related substances (sum of related substances at 260 ppb)
New restriction on oxo-degradable plastic
From July 2021, the EU’s Directive on single-use plastics (Directive EU 2019/904) required EU Member States to implement laws restricting the placing on the market of any products made from oxo-degradable plastic.
Oxo-degradable plastic only has application in single-use packaging (such as carrier bags, coffee cups, agricultural film and water bottles). This substance will be added to the packaging compliance statement in BOMcheck.
New French mineral oil restriction
An amendment to Article 112 of decree no.1010-105 on the ‘Fight against waste and the circular economy’ introduces restrictions in France on two categories of mineral oils in ink included on packaging and printing material intended for the public at the following concentrations:
From January 2023,
- MOAH (containing 1-7 aromatic rings) not greater than 1% w/w in the ink
From January 2025,
- MOAH (containing 1-7 aromatic rings) not greater than 0.1% (1000 ppm) or MOAH (containing 3-7 aromatic rings) not greater than 0.0001% (1 ppm) w/w in the ink
- MOSH (16-35 carbon atoms) not greater than 0.1% (1000 ppm) w/w in the ink
A 12-month period for the exhaustion of packaging stocks (all types) and printed papers manufactured or imported is permitted.
These two mineral oil categories will be added to BOMcheck under the Other legislation list and the Packaging compliance statement.
IF YOU HAVE CREATED FULL MATERIALS DECLARATIONS (FMDs) ON BOMcheck THEN YOU WILL NOT NEED TO TAKE ANY ACTION. The RCDs which are generated from your FMDs have been updated automatically for these new substances. The Approval Date for these RCDs has been set to 29 July 2022. The Approval Date for your FMD declarations remains the same.
If you have created RCDs on BOMcheck then you need to sign in and update your declarations for the above substances by following the v6.6 Guidance Video and v6.6 Quick Reference Guide provided by the BOMcheck Team.