Eurofins PPE Monthly Bulletin (January 2024)

EUROPE

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

On 23 January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 substances.

See below a table indicating the latest substances addition:

Nº	Substance name	EC number	CAS number	Reason for inclusion	Examples of use(s)
1	2,4,6-tri-tert-butylphenol	211-989-5	732-26-3	Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d)	Manufacture of another substance; formulation of mixtures and in fuel products.
2	2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol	221-573-5	3147-75-9	Very persistent and very bioaccumulative (vPvB) (Article 57e)	Air care products, coating products, adhesives and sealants, lubricants and greases, polishes and waxes and washing and cleaning products.
3	2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one	438-340-0	119344-86-4	Toxic for reproduction (Article 57c)	Inks and toners, coating products.
4	Bumetrizole	223-445-4	3896-11-5	vPvB (Article 57e)	Coating products, adhesives and sealants and washing and cleaning products.
5	Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol	700-960-7	-	vPvB (Article 57e)	Adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, inks, toners and polymers.

Legal obligations for companies using SVHC substances include:

Suppliers provide customers and consumers with enough information to allow for safe use of products that contain a substance of very high concern (SVHC) above a concentration of 0.1 % (weight by weight)
Importers and producers of these products must notify the ECHA if their article contains SVHC substances above a concentration of 0.1% weight by weight (w/w) and the substance is present in those products in quantities totalling over 1 tonne per producer or per importer per year. The notifications must be submitted within six months from the date that the substance is included in the list.
Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, must provide their customers with a safety data sheet.
Under the Waste Framework Directive (Directive 2008/98/EC on waste- WFD), any supplier of an article containing a substance of very high concern (SVHC) in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit a SCIP Notification on that article to ECHA, as of 5 January 2021. SCIP is the database holding information on Substances of Concern in articles, as such or in complex objects (products), established under the WFD. The SCIP database complements the existing notification obligations for Candidate List substances in articles subject to REACH regulation and its related communication through the supply chain, according to Articles 7 (2) and 33 respectively.

Click here to view the official List from the ECHA’s website.

Changes to product safety standards

On 11 December 2023, the European Commission published Decision 2023/2752 which amends the Implementing Decision (EU) 2023/941 as regards harmonised standards for mountaineering equipment, helmets for equestrian activities and gloves drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council.

Annex I to Implementing Decision (EU) 2023/941 is amended in accordance with the following table:

Entry	Amendment
63a	The following text is inserted: EN 892:2012+A3:2023 - Mountaineering equipment – Dynamic mountaineering ropes – Safety requirements and test methods
77a	The following text is inserted: EN 1384:2023 - Helmets for equestrian activities
84	It is deleted
84a	The following text is inserted: EN ISO 10819:2013 - Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013) EN ISO 10819:2013/A1:2019 EN ISO 10819:2013/A2:2022
112a	The following text is inserted: EN 13089:2011+A3:2023 - Mountaineering equipment – Ice-tools – Safety requirements and test methods

Standard updates

The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: The latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

CEN
Reference	Title	*Date of withdrawal ()**	Supersedes
EN 360:2023	Personal fall protection equipment - Retractable type fall arresters	30 June 2025	EN 360:2002
EN ISO 12311:2023	Personal protective equipment - Test methods for sunglasses and related eyewear (ISO 12311:2023)	30 June 2024	EN ISO 12311:2013

PRODUCT RECALLS / ALERTS

Below you will find a monthly summary of product recalls and alerts in Europe (Source Safety Gate (RAPEX)).

Europe

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

The following 5 alerts regarding Personal Protective Equipment were reported between week 51 of 2023 to week 3 of 2024.

Type of Risk	Number of alerts	Notes
Health risk / other	1	Particle filter mask The total filtration capacity of the mask is insufficient. The product does not comply with the Personal Protective Equipment Regulation.
Health risk / other	4	Particle filter mask The particle/filter retention of the material is insufficient. These products do not comply with the Personal Protective Equipment Regulation or EN 149.

OPSS issues Product Safety Alerts to the UK market.

The following 1 alert regarding Personal Protective Equipment (PPE) was issued between week 51 of 2023 to week 3 of 2024.

Type of Risk	Number of alerts	Notes
Injuries	1	Rope connection and redirection link The product was not supplied with the required compliance documentation or markings to demonstrate that they have been adequately conformity assessed. The absence of such independent assessment for such a product may increase the risk to the consumer that the product may not perform as expected when relied upon as a buoyancy aid. The product does not meet the requirements of Regulation (EU) 2016/425 on personal protective equipment.