Message 001
Communication from the Commission - TRIS/(2023) 1699
Directive (EU) 2015/1535
Notification: 2023/0344/FR
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20231699.EN
1. MSG 001 IND 2023 0344 FR EN 06-06-2023 FR NOTIF
2. France
3A. Ministères économiques et financiers
Direction générale des entreprises
SQUALPI
Bât. Sieyès -Teledoc 151
61, Bd Vincent Auriol
75703 PARIS Cedex 13
d9834.france@finances.gouv.fr
3B. Ministère de la santé et de la prévention
Direction générale de la santé.
Sous-direction de la prévention des risques liés à l’environnement et à l’alimentation (SD-EA)
Bureau environnement extérieur et produits chimiques (EA1)
14 avenue Duquesne
75350 Paris 07 SP
Ministère de l'économie, des finances et de la souveraineté industrielle et numérique
DGCCRF/Bureau des produits et prestations de santé et des et des services à la personne (5B)
4. 2023/0344/FR - X00M - GOODS AND MISCELLANEOUS PRODUCTS
5. Decree on information on intimate care products
6. Intimate care products for external use (absorbent towels, panty liners, menstrual panties, etc.) and for internal use (tampons, menstrual cups, menstrual sponges, etc.)
7.
8. This draft decree provides for the improvement of consumer information on intimate care products regarding the composition of these products, the modalities and precautions for their use, the health risks associated with the composition or mode of use of these products, in particular the risk of toxic shock syndrome.
This draft decree applies to intimate care products which include intimate care products for external use – such as absorbent towels, panty liners, and menstrual panties – as well as intimate care products for internal use such as tampons, menstrual cups, and menstrual sponges.
The draft decree defines the content of the information which must appear on the packaging and the leaflet accompanying intimate care products placed on the market, and specifies the manner in which it is brought to the consumer’s attention. This mandatory information shall relate more specifically to (i) the composition of the intimate care products which will be presented in the form of a list of components and for each of these components, the details of the substances and materials, ii) the modalities and precautions for the use of such products and (iii) the health risks associated with the composition or use of such products.
These new obligations apply to the person responsible for the first placing on the market of the product. As a matter of priority, it is the manufacturer (or the company on whose behalf the product is manufactured) or the importer who must also ensure that the products comply with the regulations.
The draft decree also contains a mutual recognition clause allowing an intimate care product lawfully manufactured or marketed in another EU Member State or in Türkiye, or legally manufactured in a State party to the Agreement establishing the European Economic Area, to be marketed in France.
Finally, the draft text provides for a transitional period of six months following its entry into force in order to allow economic operators time to comply and dispose of their stocks.
9. Article 5(1) of Directive 2001/95 provides that producers are to provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks.
The draft decree aims to require manufacturers of intimate care products to provide consumers with the relevant information to assess the risks inherent in such products, in accordance with this provision of Directive 2001/95/EC.
As regards the risks inherent in intimate care products, it should be noted that the European Parliament adopted on 24 June 2021 a resolution on the situation of sexual and reproductive health and rights in the EU, in the frame of women’s health (2020/2215(INI)), in particular point 24, which calls for access for all to toxin-free menstrual products. Requests to this effect from women’s associations have also been received by the French government.
The requirements set out in the draft decree, in consultation with stakeholders in France, aim to meet this objective of protecting women’s health and are based on the recommendations of the National Agency for Food, Environmental and Occupational Safety (ANSES). An initial ANSES opinion, published in 2018 (revised in 2019), concerned risks relating to intimate care products, recommending the improvement of transparency on the composition of these products, strengthening the information provided on the proper use of such products and the associated risks, in particular toxic shock syndrome. In July 2022, it was followed up by a scientific and technical note in support of the draft decree.
In this context, information on the composition, modalities of use and health risks associated with the composition or use of intimate care products to be affixed to the packaging of those products appears to be a necessary and appropriate measure to enable the safe use of such products. The draft decree sets out the minimum information to be provided to consumers when using intimate care products.
10. References to basic texts:
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
