Chemical compliance

What’s happening? Here is an update for July 2024:

Chemical regulations enforcement: next EU projects announced
Mercury: new EU bans approved
Mineral oils: upcoming restriction on use in France
Restriction of siloxanes: EU and USA make progress

Chemical regulations enforcement: next EU projects announced

The European Chemical Agency’s (ECHA) Enforcement Forum – a network of enforcement authorities from the EU and EEA who are responsible for coordinating enforcement of European chemical regulations – has selected its next EU-wide REF-14 project.

Throughout 2026, inspectors will check if hazardous mixtures in products, such as air fresheners or electronic cigarettes, are classified, labelled and packaged correctly to protect consumers and children from chemical hazards.

These consumer products are widely available on the market and known to contain hazardous mixtures, such as nicotine products with acutely toxic substances or air fresheners with sensitising or irritant substances.

The authorities have also noted that these products are sometimes not classified and labelled correctly or do not have child resistant fastening, which may expose children to risk.

The Forum also agreed that its next pilot enforcement project will focus on Only Representatives who register imported substances on behalf of non-EU manufacturers.

Landbell Group’s chemical consultancy, H2 Compliance is strongly present in both services – hazard communication and representative services – helping companies with assessments and implementation of compliance solutions.

Visit the ECHA website for more information.

Mercury: new EU bans approved

On 30 May 2024, the Council of the European Union (EU) adopted an amendment to the Mercury Regulation to completely ban the use of dental amalgams and to prohibit the manufacturing, import and export of other mercury-added products.

The updated rules aim to address the remaining use of mercury in line with the EU´s zero pollution ambition.

Current rules already ban the use of dental amalgam for children under 15 years old, and for pregnant or breastfeeding women.

The new ban will extend to all patients in the EU as of 1 January 2025 (with exceptions if dental practitioners deem the use of filling material to be strictly necessary).

Exporting dental amalgam will be prohibited from 1 January 2025; the ban on manufacturing and import in the EU will apply from 1 July 2026.

An import and export ban on six additional mercury-containing lamps will also take effect from 31 December 2025 and 31 December 2026.

The regulation is to be signed and published in the Official Journal of the EU before entry into force.

The European Commission will review the exemptions on the use of dental amalgam by 31 December 2029, taking into account the availability of mercury-free alternatives.

It will also review measures taken by Member States on mercury emissions from crematoria and the impact of the Commission’s guidance on relevant abatement technologies.

Adopted in 2017, the EU mercury regulation is one of the key instruments transposing the Minamata Convention, an international treaty signed in 2013 to protect human health and the environment from the adverse effects of mercury.

It covers the full life cycle of mercury, from primary mining to waste disposal.

Mineral oils: upcoming restriction on use in France

From 1 January 2025, France will implement stricter regulations on the use of mineral oils in packaging and inks with bans on the following substances for use in printing inks:

• Mineral oil saturated hydrocarbons (MOSH) with 16 – 35 carbon atoms, and
• Mineral oil aromatic hydrocarbons (MOAH) with 1 – 7 aromatic rings

Mineral oils, derived from petroleum hydrocarbons, are commonly used in the manufacture of inks.

The health impacts of these substances vary with MOAH potentially acting as genotoxic carcinogens and some MOSH known to accumulate in the liver and lymphoid system.

Regulatory Timeline

The regulation came into effect in 2023 and foresees the following deadlines:

• Until 31 December 2024: the ban applies to MOAH concentration in ink exceeding 1%
• On 1 January 2025: the ban extends to the use of:
  1. MOAH where the concentration exceeds 0.1% or mass concentration in ink compounds with 3-7 aromatic rings exceeds 1 ppm (mg/kg), and
  2. MOSH where the concentration exceeds 0.1% in the ink

Some exceptions apply to printing services, if duly authorised.

Additionally, packaging and printed paper manufactured or imported before the relevant deadline can be stocked for up to 12 months after the deadline.

Landbell Group company, H2 Compliance supports companies in complying with the restrictions on mineral oil.

Find more information on the H2 Compliance website.

Restriction of siloxanes: EU and USA make progress

In May 2024, the European Commission adopted a restriction on the use and marketing of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6). See article in June’s COMPASS here.

Commonly found in silicone rubbers, gels, solvents and resins, these chemicals are integral to various industries, including cosmetics, textile cleaning products, healthcare and construction.

From 6 June 2026, the restriction will prohibit the use or sale of these substances or mixtures containing them in a concentration of 0.1% by weight or higher.

Deferred timelines from 2027 to 2034 are foreseen for specific uses in cosmetic, medicinal and veterinary products, medical devices and dry cleaning, as well as certain industrial uses, art restoration and lab reagents.

The European Commission has also initiated a draft proposal to nominate these substances as persistent organic pollutants (POPs) under the Stockholm Convention in 2020. The European Council is reviewing the proposal.

In the US, the Environmental Protection Agency (EPA) began a TSCA risk evaluation for D4 in 2020 at the industry’s request, but this review is not expected to be completed soon due to a backlog of evaluations.

Meanwhile, individual US states like Washington and Vermont are considering their own measures to regulate these substances.

To avoid non-compliance, companies impacted by the restriction should check the use of siloxanes in their products and update their restricted substances lists and chemical policies to sufficiently communicate the risk and obligations to their suppliers.

Find more information on the H2 Compliance website.