May Regulatory Updates

  • Food:

EU adhesives and sealants body submitted guidance on MOH migration in FCMs.

The Association of the European Adhesive and Sealant Industry (FEICA) has published a guidance document on how to evaluate the potential migration of adhesives containing mineral oil hydrocarbons (MOHs) from food contact materials (FCMs).

The goal is to aid adhesive producers and users in the compliance with the rules on MOH release into food under article 3 of the EU FCM regulation.

EU authorities and experts have recognised printing inks used on graphic or newsprint paper as a major contributor to the presence of the substances in recycled paper, which can leech into packaged food, causing concerns over consumer safety.

This is further complicated, FEICA said, by the difficulties of MOH analysis in adhesive raw materials such as waxes, resins and oligomers.

The guidance appears ahead of the European Commission’s long-delayed proposal to redraft the FCM regulation which will not be ready until at least 2025.

 

  • Cosmetics:

European Commission presented regulatory action on more nanomaterials used in cosmetics.

The European Commission has changed its draft regulation concerning measures for certain nanomaterials in cosmetics products by adding a proposal to ban colloidal silver (nano) and to restrict hydroxyapatite (nano).

The move alters a February 2022 draft text that initiated a ban on five nanomaterials, or groups of them, which resurfaced almost seven years after the EU executive first launched a call for data on some of the substances.

The draft, which amends the cosmetics products regulation, now includes the following substances in Annex II – the list of those forbidden for use:

– styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano);

– copper (nano) and colloidal copper (nano);

– colloidal silver (nano);

– gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano) and acetyl heptapeptide-9 colloidal gold (nano); and

– platinum (nano), colloidal platinum (nano) and acetyl tetrapeptide-17 colloidal platinum (nano).

The Commission has proposed introduction of hydroxyapatite (nano)  given that potential risk to human health arises from the use of the chemical when the concentration surpass certain levels or when it is used in sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.

The EU executive is therefore planning to restrict it to a maximum concentration of 10% in toothpaste and of 0.465% in mouthwash.

For all these substances, the EU executive is suggesting a transition period of nine months after the regulation’s entry into force for industry to stop placing cosmetics products that contain them on the market.

There have been many developments on substances of concern in cosmetics products recently: in February, trade association Cosmetics Europe released a free online database where consumers can find information about 30,000 cosmetics ingredients.

 

The European Commission’s Scientific Committee on Consumer Safety has submitted a draft about concentration limits for the use of methyl salicylate in cosmetics for use by children.

Methyl salicylate is frequently used in fragrances, as a flavouring agent and as a soothing agent in oral hygiene products.

The substance is classified as reprotoxic (category 2) under CLP, triggering regulatory measures under the cosmetics regulation.

In its draft opinion, published on 16 May, the committee expands on its 2021 opinion, concluding that methyl salicylate is safe in certain cosmetics for children of six months to three years, used in concentrations of up to 0.02%. The conclusion explicitly covers shower gel, hand soap, shampoo, body lotion, face cream, hand cream and lip products.