Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political and legal measures, with major impacts for all actors, including actors of the healthcare sector.

Key points

In this context of strong regulation in favour of the environment, it seems important to review the new obligations introduced by the Agec law, with which manufacturers in the healthcare sector are confronted, particularly with regard to:

• The display of sorting signs (“Triman” logo and “info-tri” instructions) on products and packaging, in particular for medicinal products and medical devices;
• Informing consumers about the environmental qualities and characteristics of products and packaging;
• A ban on the use of the words “environmentally friendly” or “any other equivalent term” on products and packaging;
• The use of mineral oils on packaging;

The presence of microplastics in medical devices or cosmetics.

The Agec law: a major impact for the protection of the environment

The AGEC law (on the fight against waste and on the circular economy), adopted on the 10^th of February 2020, covers many different areas of the law and introduces several significant measures with the aim of profoundly transforming our production and consumption system. These measures can be broken down through into five main areas:

(1) Phasing out of disposable plastic;

(2) Better informing consumers;

(3) Waste management by fighting against waste and for solidarity reuse; (here lie the measures regarding packaging recyclability, incorporation of recycled material, packaging reuse etc);

(4) Acting against obsolescence;

(5) Better production methods.

These objectives are reflected in a large number of new obligations, prohibitions and tools likely to have a direct or indirect impact on most companies across all sectors.

Extended producer responsibility (EPR): contributions extended to perforating medical devices and self-tests

The development of the circular economy requires the support of all manufacturers. Companies of the healthcare sector which products generate waste at the end of their life cycle will not be able to avoid being subject to these new obligations.

The Agec Law has therefore extended the list of sectors subject to EPR (which already included packaging, electrical and electronic equipments (EEE) and medicines[1]) to perforating medical devices (MD) and self-tests.

Any producer of medicinal products, medical devices, food supplements or cosmetics is likely to be concerned (even from just a packaging perspective), and must therefore be vigilant, given the diversity of the new requirements introduced by the Agec law and the importance of the measures that may be required to implement such requirements.

A priority area : information of consumers… and patients!

Measures relating to consumer information are particularly important in managing the end-of-life of products. The Agec law introduces two key measures: the obligation to affix harmonised labelling (“Triman” logo and “info-tri” instructions) on all products and packaging, and the obligation to inform consumers about the environmental qualities and characteristics of products and packaging.

• The obligation to display harmonised sorting signs (“Triman” logo and “info-tri” instructions)[2]

Each EPR sector concerned by this new obligation has its own sorting sign.

For medicines, a dedicated “info-tri” service has been developed by Cyclamed[3] in partnership with the eco-organisms for household packaging, to inform “consumer-patients” on the management of household pharmaceutical waste and thus limit the environmental impact of unused or expired medicinal products.

Due to the obligation to hold a safety stock of medicinal products destined for the national market[4], medicinal products and medical devices benefit from an extended stock clearance period.

It is important to note, however, that on the 15^th of February 2023, the European Commission opened an infringement procedure against France regarding the Triman and “info-tri” labelling obligation, in particular as a result of the absence of harmonisation at European level, the infringement of the principle of free movement of goods, and the risk linked to potential counterproductive effects on the environment (additional labelling materials, larger packaging sizes).

Pending the outcome of this procedure, compliance with French labelling rules remains mandatory.

• The obligation to inform consumers on the environmental qualities and characteristics of products and packaging[5]:

This obligation, which has been in force since the 1^st of January 2023, requires consumers to be informed, via a dematerialised display system (a “product information sheet”), with precise information depending on the product category concerned: incorporation of recycled material, use of renewable resources, durability, compostability, reparability, possibility of re-use, recyclability and the presence of hazardous substances, plastic microfibres, precious metals or rare earths.

However, it is not always easy to determine which elements qualify as packaging. Citéo (the eco-organism responsible of household packaging) has issued the following clarification concerning health products: measuring glasses, spoons, pipettes and other administration instruments are not considered household packaging and should not be sorted in the waste bin.

Overview of other measures likely to have an impact on the healthcare sector

• A framework for environmental claims[6]

An important measure concerns the regulation of environmental claims with the introduction of new strict requirements to prevent greenwashing practices: prohibition to display “environmentally friendly” or “any other equivalent term[7]” on products or packaging.

• Dispensing single units of medicines[8]

In order to fight against waste, the Agec law introduced an article allowing pharmacists to dispense single units of medicines, where their pharmaceutical form allows it, so that the patient is provided with only the needed quantity rather than a complete box.

As a result, from the 1^st of March 2022, pharmacists will be authorised to dispense antibiotics by the unit[9].

• Ban on the use of mineral oils on packaging[10]

The aim of this ban is to prevent the use of mineral oils containing substances that interfere with the recycling of waste or limit the use of recycled material because of the risks these substances present to human health. The terms of application of this ban, the maximum tolerated levels of MOSH and MOAH in inks and the deadlines for the entry into force of this ban have been specified by decree and order.

• Ban on microplastics[11]

As from 2024, medical devices containing microplastics will be prohibited (with the exception of those that are biodegradable or chemically unmodified).

Cosmetics are also concerned by this measure, in particular rinsed cosmetic products used for exfoliation or cleansing and, from the 1^st of January 2026, all other rinsed cosmetic products (shampoos, colouring products, shower gels and make-up removers) will be concerned.

[1]Article L. 4211-2-1 of the public health code

[2] Article 17 of the Agec law

[3] Government-approved eco-organism for unused medicines

[4] Article L. 5121-29 of the public health code

[5] Article 13 of the Agec law

[6] Article 13 of the Agec law

[7] In accordance with article L. 541-9-1 of the environment code

[8] Article 40 of the Agec law

[9] Order of 1^st March 2022 creating the list of specialties that may be subject to unit dispensing in application of article R. 5132- 42-2 of the public health code

[10] Article 112 of the Agec law

[11] Article 82 of the Agec law