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Key Facts

France

Map of France

Reception Date

06.06.23

Category

GOODS AND MISCELLANEOUS PRODUCTS

GOODS AND MISCELLANEOUS PRODUCTS

Ministries & Departments

Ministère de la santé et de la prévention

Responsible Departments

Ministères économiques et financiers

Products & Services concerned

Intimate care products for external use (absorbent towels, panty liners, menstrual panties, etc.) and for internal use (tampons, menstrual cups, menstrual sponges, etc.)

Related EU Law

None

Explanation

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.

Summary

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.

Notification Timeline

This timeline summarizes key events in the notification process

Law is drafted in France France notifies the draft law 06.06.23 Draft law returns to France Commenting Periode Ends 07.09.23 1 Member States & EC Responses 0 Detailed Opinions 0 Comments 1 External Stakeholders Responses

Notification Comparison

Track the evolution of this law — uncover the changes made from draft to final version based on input from the Commission, key organisations, and Member States.

Highlighted sections mark additions, and crossed-out text marks what was removed.

Document Corner
EU Flag
Originating Department: Ministère de la santé et de la prévention
Responsible Department: Ministères économiques et financiers
Received: 2023-06-06 00:00:00
Country: France
Category: GOODS AND MISCELLANEOUS PRODUCTS

Decree on information on intimate care products

Notification No.: 2023-0344-FR

THE FRENCH REPUBLIC
Ministry for Health and Prevention
Decree on Information on Intimate Care Products
NOR:
Groups concerned: manufacturers, importers, distributors, consumers of these products
Purpose: Definition of the information which must appear on the packaging or leaflet of
intimate care products.
Entry into force: the text enters into force on 1st January 2024
Leaflet: It defines the content of the information which must appear on the packaging of
intimate care products placed on the market and the manner in which it is brought to the
consumer’s attention. Intimate care products include intimate care products for external use
– such as absorbent towels, panty liners, menstrual panties – as well as intimate care
products for internal use such as tampons, menstrual cups, menstrual sponges.
References: The provisions of the decree can be consulted, in their drafting resulting from
this modification, on the Légifrance website (https://www.legifrance.gouv.fr).
Decree No 2023-1427 of 30 December 2023 on Information
on certain Intimate Care Products
NOR: SPRP2329066D
ELI: https://www.legifrance.gouv.fr/eli/decret/2023/12/30/SPRP2329066D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2023/12/30/2023-1427/jo/texte
Official Journal of the French Republic No 0304 of 31 December 2023
Text No 112
 Annex
Groups concerned: manufacturers, importers, distributors, consumers of intimate
care products.
Purpose: Definition of the information which must appear on the packaging or
leaflet of intimate care products.
Entry into force: the provisions of this Decree enter into force on 1 April 2024,
under the conditions referred to in Article 7.
Notice: The Decree defines the content of the information which must appear on
the packaging of intimate care products (absorbent pads, panty liners, menstrual
panties, tampons, menstrual cups, menstrual sponges) placed on the market and the
manner in which they are brought to the consumer’s attention.
References: the Decree can be consulted on the Légifrance website
(https://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Economy, Finance and Industrial and Digital Sovereignty and
the Minister for Health and Prevention;
Having regard to Regulation (EU) 1007/2011 of the European Parliament and of the Council
of 27 September 2011 on textile fibre names and related labelling and marking of the fibre
composition of textile products and repealing Council Directive 73/44/EEC and Directives
96/73/EC and 2008/121/EC of the European Parliament and of the Council;
Having regard to the amended Regulation (EU) 2017/745 of the European Parliament and of
the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation
(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC;
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of information in the field of
technical regulations and of rules on Information Society services;
In view of the consumer code, in particular articles L. 412-1, L. 423-1, R. 412-1 and R. 451-1;
Having regard to notification No 2022/0XXX/F addressed on XXXX to the European
Commission;
On the report of the Minister of Economy, Finance and Industrial and Digital
Sovereignty and of the Minister for Health and Prevention;
Having regard to Regulation (EU) 1007/2011 of the European Parliament and of
the Council of 27 September 2011 on textile fibre names and related labelling and
marking of the fibre composition of textile products and repealing Council
Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European
Parliament and of the Council;
Having regard to the amended Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009;
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the
Council of 9 September 2015 laying down a procedure for the provision of
information in the field of technical regulations and of rules on Information Society
services, together with the notification addressed to the European Commission on
6 June 2023;

Having regard to the scientific and technical support note of the National Agency for Food,
Environmental and Occupational Health & Safety of 21 July 2022;
Having regard to Directive 2000/31/EC of the European Parliament and of the
Council of 8 June 2000 on certain legal aspects of information society services, in
particular electronic commerce, in the Internal Market (‘Directive on electronic
commerce’), together with the notification addressed to the European Commission
on 7 September 2023;
Having regard to the Consumer Code, in particular Articles L. 120-1, L. 321-1, L.
412-1, L. 421-1 to L. 421-7, L. 422-1 and R. 412-1 thereof;
Having regard to the opinion of the National Agency for Food, Environmental and
Occupational Health & Safety of 21 July 2022;
Having regard to notification No 2023/0344/F of 6 June 2023 and the notification
of 7 September 2023 addressed to the European Commission;
Having heard the Council of State (Finance section),
Hereby decrees
Hereby decrees:
Article 1
The provisions of this Decree apply to intimate care products imported or introduced into
French territory, held for sale or distribution free of charge, offered for sale, or distributed free
of charge.
The following definitions apply: “Intimate care products” means single use or reusable
products, intended to absorb or retain body fluids and to be put in contact with the internal or
external genitourinary system of the pubescent human body.
The provisions of this Decree shall not apply to medical devices as defined in Regulation
(EC) No 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC)
No 1223/2009 and repealing the Council Directives 90/385/EEC and 93/42/EEC referred to
above.
The provisions of this Decree apply to single use or reusable products, intended
to absorb or retain body fluids and to be put in contact with the internal or
external genitourinary system of persons who have reached puberty and which
are kept for sale or for distribution free of charge.
These provisions do not apply to medical devices defined by the above-
mentioned Regulation of 5 April 2017.
Article 2
I. – The packaging of intimate care products shall bear the following information:
(1) the composition of the product, in the form of a list containing all the components that are
present and for each of these components, the details of the substances and materials that each
includes intentionally incorporated during the manufacturing process of the finished product.
This provision does not apply to textile products, subject to the specific provisions of
Regulation No 1007/2011 of the European Parliament and of the Council of 27 September
2011 on textile fibre names and related labelling and marking of the fibre composition of
textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and
2008/121/EC of the European Parliament and of the Council referred to above;
(2) the terms and precautions of use, in particular those specified in the annex to this Decree;
(3) the health risks associated with the composition or use of the product (in particular
irritations, intolerances, allergies, micro-trauma). In particular, for intimate care products for
internal use, this information contains the information detailed in the annex to this Decree on
menstrual toxic shock syndrome and on the symptoms that should lead to prompt medical
consultation.
The information mentioned from (1) to (3) shall be in indelible, visible, legible and
comprehensible characters in the French language.
The packaging of products mentioned in Article 1 shall bear the following
information written in French and in indelible, visible, legible and
understandable characters:
1. The composition of the product, in the form of a list containing all the
components that are present and, for each of these components, the details of
the substances and materials intentionally incorporated during the
manufacturing process of the finished product. This provision does not apply to
textile products, which are subject to the specific provisions of the above-
mentioned Regulation of 27 September 2011;
2. The health risks associated with the composition or use of the product, in
particular as regards irritations, intolerances, allergies, micro-trauma;
3. The terms and precautions for the use of these products as well as the health
risks mentioned in point 2 are set out in the Annex to this Decree.
Article 3
When the products mentioned in Article 1 are offered for sale by means of

II. – When intimate care products are offered for sale by means of distance communication,
the information referred to in I shall be provided before the completion of the purchase and
shall appear on the distance selling medium.
III. – When several intimate care products are distributed in the same packaging designed to
constitute a sales or distribution unit for the end user or the consumer, certain information
referred to in I may appear on an accompanying leaflet. In this case, the packaging shall
indicate:
(1) at least the following information: the risk of menstrual toxic shock syndrome related to
the use of intimate care products for internal use, the maximum wear period for these
products, the recommendation for wearing intimate care products for external use at night, the
appropriate choice of protection in relation to the menstrual flow and the composition as
defined in (1) of I.
(2) that details of the terms and precautions of use as well as the health risks associated with
the composition or use of the products are set out in the leaflet.
IV. – When intimate protective products are intended to be sold or distributed free of charge
individually or in bulk in accordance with the provisions of Article D.120-5 of the Consumer
Code, or where the size of the product and its packaging makes it manifestly impossible to
comply with the requirements of I, the information required shall be contained in a leaflet
accompanying the product.
Article 3
The provisions of this Decree shall not prevent the placing on the market in France of intimate
care products lawfully manufactured or marketed in another Member State of the European
Union or in Turkey, or lawfully manufactured in a State party to the Agreement establishing
the European Economic Area, in so far as they are accompanied by information ensuring a
level of safety equivalent to that required by this Decree.
distance communication, the information referred to in Article 2 shall be
provided before the completion of the purchase and shall appear on the distance
selling medium.
Article 4
This Decree shall enter into force on 1st January 2024. Products which do not comply with
the provisions of this Decree placed on the market before this date may continue to be offered
for sale or distributed free of charge for six months from this date.
Where the size of the packaging does not allow all the information referred to
in Article 2 to appear in it, it may appear on a package leaflet accompanying it.
In this case, the packaging shall indicate at least the following information: the
composition, the risk of menstrual toxic shock syndrome related to the use of
products for internal use, the maximum wear period for these products, the
recommendation for wearing products for external use at night, the appropriate
choice of protection in relation to the menstrual flow.
Article 5
The Minister of Economy, Finance and Industrial and Digital Sovereignty, the Keeper of the
Seals, the Minister of Justice, the Minister for Health and Prevention, the Minister Delegate
attached to the Prime Minister, responsible for gender equality, diversity and equal
opportunities, the Minister Delegate attached to the Minister of Economy, Finance and
Industrial and Digital Sovereignty, responsible for small and medium-sized enterprises, trade,
Where the products referred to in Article 1 are intended to be sold or
distributed free of charge individually or in bulk in accordance with Article L.
120-1 of the Consumer Code, the information required shall be contained in a
leaflet accompanying the product or displayed nearby.
Article 6
The provisions of this Decree shall not prevent the placing on the market in
France of products lawfully manufactured or marketed in another Member
State of the European Union or in Turkey, or lawfully manufactured in a State
party to the Agreement establishing the European Economic Area, in so far as
they are accompanied by information ensuring a level of safety equivalent to
that required by this Decree.
Article 7
This Decree shall enter into force on 1 April 2024.
Products which do not comply with the provisions of this Decree placed on the
market before this date may continue to be offered for sale or distributed free of
charge until 31 December 2024.
Article 8
The Minister of Economy, Finance and Industrial and Digital Sovereignty, the

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Commenting Organisations

This section lists all organisations that have submitted comments on this notification. Each entry includes the organisation’s name, the number of contributions made, and a link to view their comments. Explore the list to understand which stakeholders are actively engaging in the consultation process.
Organisation Comments Date Total Contributions
EDANA Download 2023-07-11 2
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