We inform you that additional
dates for virtual training sessions are available on the EUDR Information
System by the Commission:
- 3 July (14:00),
- 10 July (14:00).
Next training dates will be announced from September.
The Commission Delegated
Regulation (EU) 2025/1222 of 2 April 2025, amending Regulation (EC) No
1272/2008 of the European Parliament and of the Council as regards the
harmonised classification and labelling of certain substances, has just been
published in the Official Journal of the European Union.
It brings changes to the classification and labelling of some existing
harmonized substances and adds new harmonized substances in Part 3 of Annex VI.
In particular, we draw your attention on ozone (CMR), Protoxyde d’azote (CMR)
and Chrysanthemum cinerariaefolium, extract from open and mature flowers of
Tanacetum cinerariifolium obtained with supercritical CO2 and with hydrocarbon
solvents (skin sensitizer and STOT).
>> FICHE PAYS ESPAGNE
Dans le cadre de notre collaboration avec Ingrecos et la FEBEA sur la rédaction
de fiches pays qui visent à informer des démarches d’accès et de partage des
avantages (APA) auprès des autorités nationales compétentes de chaque pays,
vous trouverez ci-jointe la fiche actualisée de l’Espagne, qui a été validée
par les autorités nationales compétentes ou par les points focaux.
En tout état de cause, ce document n’a aucune valeur juridique, il ne dispense
pas de consulter les textes et lois officiels mais ils sont un bon support
d’information.
N’hésitez pas à nous faire part de vos remarques suite à vos expériences.
>> FICHE PAYS INDE
Un nouveau règlement pour gérer le partage des bénéfices générés par
l’utilisation des ressources biologiques a été notifié le 29 avril dernier.
Nous prévoyons de soumettre prochainement au point focal une actualisation de
notre fiche avec le règlement pour validation finale tout en soumettant un
certain nombre de questions, en particulier sur la période de mise en place et
par rapport aux guidelines de 2014 qui ne semblent pas abrogés.
IL NOUS SERAIT TRES UTILE DE RECUEILLIR EGALEMENT LES QUESTIONS QUI SE POSENT A
VOUS D’ICI LE 25 JUIN ; une réunion de compilation de toutes les questions des
entreprises est prévue à la fin du mois.
Merci par avance pour votre contribution.
Sur l’ensemble des pays listés, seuls quatre pays figurent dans la catégorie
"risque élevé" (Biélorussie, République populaire démocratique de
Corée, Myanmar/Birmanie, Fédération de Russie) et les autres dans la catégorie
"risque faible". Le niveau standard est maintenu pour tous les pays
ne figurant pas dans ces deux listes.
Cette classification vise à permettre aux autorités compétentes des États
membres de définir et de planifier leurs contrôles de conformité annuels lors
de leurs importations, à savoir 1 % pour les pays à faible risque, 3 % pour
ceux à risque standard et 9 % pour ceux à risque élevé, dans le cadre d'une
approche fondée sur le risque. En outre, elle vise à inciter les pays à
améliorer la durabilité de leurs systèmes de production agricole et à réduire
l'impact de la déforestation et de la dégradation des forêts.
Une méthodologie est détaillée dans un document de travail des services de la
Commission. Elle est basée sur les données de l'évaluation des ressources
forestières mondiales menée par l'Organisation des Nations unies pour
l'alimentation et l'agriculture. Les données nationales peuvent être consultées
sur le site web public de la FAO.
> Règlement d’exécution n° 2025/1093.
> Document de travail de la Commission (en anglais).
Par ailleurs, vous trouverez en annexe le calendrier des prochaines sessions de
formation et d’utilisation du système d’information EUDR pour le mois de juin.
We inform you that the 7th
Omnibus Regulation on CMR substances has been published by Commission
Regulation (EU) N° 2025/877 of 12 May 2025 (Official Journal of the EU of 13
May 2025) amending Regulation (EC) N° 1223/2009 of the European Parliament and
of the Council on cosmetic products.
This regulation amends Annex II adding 21 banned substances and 1 revised
banned ingredient. It also amends Annex III with the deletion of 1 substance.
No request for use in cosmetic products by way of exception has been submitted
for these substances.
Omnibus VII shall enter into force on the 2 June 2025 and will apply from the
1st of September 2025.
Comme annoncé dans notre
information du 18 mars dernier, nous vous informons que la Commission
européenne a actualisé son document d’orientation sur le règlement UE
n°2023/1115 (RDUE) (en anglais) et sa Foire aux questions (FAQ) fournissant aux
entreprises, aux autorités des États membres de l'UE et aux pays partenaires
des mesures simplifiées supplémentaires et des clarifications sur la manière de
démontrer que leurs produits sont sans déforestation :
La Commission organise également une consultation publique ouverte jusqu’au 13
mai 2025 sur le projet de règlement délégué modifiant l’annexe I du règlement
2023/1115 relatif à la déforestation importée (RDUE).
Par ailleurs, vous trouverez en annexe le calendrier des prochaines sessions de
formation et d’utilisation du système d’information EUDR pour le mois de mai.
UNITIS, en collaboration avec
INGRECOS et la FEBEA, travaille sur la rédaction de fiches pays qui vise à
informer des démarches d’accès et de partage des avantages (APA) auprès des
autorités nationales compétentes de chaque pays.
Dans ce cadre, nous souhaiterions savoir si vous avez des questions
particulières concernant l'Afrique du sud.
N’hésitez pas à nous faire part de vos questions par retour de mail à mbesse@unitis.org.
We would like to inform you of
several developments concerning the European regulation on deforestation and
forest degradation (RDUE).
Firstly, an agreement between the European co-legislators was reached on
December 3 to postpone the date of application of the EUDR by one year. This
means that regulatory obligations for businesses will apply from December 30,
2025, with an extra six months for small and micro-businesses, i.e. June 30,
2026.
In addition, the implementing act for the information system has been published
in the Official Journal of the EU, and the European Commission has announced
that it will go live.
In addition to the user guide and training materials for the information
system, new training dates are proposed by the Commission:
- 16 december 13h30
- 16 december 15h
- 19 december 13h30
- 19 december 15h
- 9 january 13h30
- 9 january 15h
- 13 january 13h30
- 13 january 15h
- 16 january 13h30
- 16 january 15h
- 20 january 13h30
- 20 january 15h
A tutorial with French subtitles should also soon be available online.
To familiarize itself with the system, the Commission maintains a test
platform, the ACCEPTANCE server, which allows users to explore the
functionalities of the information system.
Access to the information system to formally enter due diligence statements is
via the LIVE server. Due diligence declarations submitted via this server will
have legal value, and must concern products intended to be placed on the market
or exported after the date on which the regulation comes into force.
Both services are available in all EU languages.
For any technical questions relating to the information system, please contact SANTE-TRACES@ec.europa.eu.
On Thursday 13 November 2024, the
European Parliament approved the report by one year of the law against deforestation
(see our news item of October 16th, 2024). Operators will therefore have to
comply with the obligations arising from the legislation from December 30,
2025, while small businesses will have until June 30, 2026.
Parliament also created a new category of countries with “zero risk” of
deforestation, in addition to the three existing categories of “low”,
“standard” and “high” risk. Products from countries classified as “zero risk”
would have lighter obligations, including not being subject to due diligence
requirements.
Parliament's amendments have rekindled discussions, and the Commission and
member states must now validate them.
Note : It is now possible for companies concerned by the RDUE obligations to
register in the information system in which due diligence declarations must be
recorded. To access the system, simply follow this link: https://eudr.webcloud.ec.europa.eu/tracesnt/login.
Submission of due diligence declarations will not be possible until December
2024.
Detailed information on the information system, including training videos and
the user guide, is available on the European Commission website.
New training sessions will be offered shortly by the European Commission and
published on its website.
The European Directorate for
the Quality of Medicines & Healthcare (EDQM), a body of the Council of
Europe, has published the second version of its “Guidance on essential oils in
cosmetic products” with best practices for safety assessment.
It includes:
• an overview of the current regulatory context and guidance;
• quality criteria, from raw materials to production, for essential oils;
• evaluation of risk-assessment approaches to safety data and toxicological
thresholds;
• practical recommendations regarding safety assessment.
Guidance - English version.
Guidance - French version.
UNITIS, en collaboration avec
Ingrecos et la FEBEA, a travaillé sur la rédaction de fiches pays qui visent à
informer des démarches d’accès et de partage des avantages (APA) auprès des
autorités nationales compétentes de chaque pays.
Vous trouverez ci-joint les fiches de la Croatie, du Japon, de l’Afrique du
Sud, de l’Espagne, de l’Éthiopie, de la Polynésie française et des Pays-Bas.
Ces dernières ont été validées par les autorités nationales compétentes ou par
les points focaux.
En tout état de cause, ces documents n’ont aucune valeur juridique, ils ne
dispensent pas de consulter les textes et lois officiels mais ils sont un bon
support d’information.
N’hésitez pas à nous faire part de vos remarques suite à vos expériences.
Consulter les fiches pays :
- Afrique du Sud,
- Croatie,
- Espagne,
- Éthiopie,
- Japon,
- Pays-Bas,
- Polynésie Française.
La Commission européenne a
annoncé dans un communiqué de presse qu’elle déposait une proposition
législative relative au règlement n°2023/1115 contre la déforestation et la
dégradation des forêts, dit RDUE (cf. notre information du 24 novembre 2023),
proposant un délai supplémentaire de 12 mois avant son entrée en vigueur
complète. Cette décision fait suite aux demandes des partenaires mondiaux,
exprimant des préoccupations quant à leur état de préparation.
Ainsi, la date d'application du règlement devrait être repoussée au 30 décembre
2025 pour les grandes entreprises et au 30 juin 2026 pour les microentreprises
et les petites entreprises.
Cette proposition législative devra être approuvée par le Parlement et le
Conseil de l’Union Européenne pour être adoptée.
Par ailleurs, la Commission a publié des orientations supplémentaires afin de
clarifier les modalités d'application du règlement. Ces documents incluent des
clarifications notamment sur les exigences en matière de traçabilité et sur les
définitions clés comme la "dégradation des forêts" ou les sanctions
prévues, ainsi que la dernière édition de la foire aux questions, dans laquelle
plus de 40 nouvelles questions ont été ajoutées.
Une page internet dédiée aux obligations des PME ainsi qu’une page qui liste et
explicite certaines contre-vérités relatives au RDUE ont été mises en ligne.
Un cadre stratégique de coopération a été publié mettant en avant les principes
et les modalités d'actions à l'international dans l'objectif d'accompagner et
soutenir la lutte contre la déforestation dans les pays tiers dans le contexte
du RDUE.
Le cadre méthodologique qui sous-tendra l'évaluation des pays à risque sera a
priori publié d'ici peu, la Commission ayant indiqué qu'une majorité des pays
sera classée à faible risque selon cette approche.
Enfin, la Commission a également développé un système informatique dédié pour
enregistrer les déclarations de diligence raisonnée des entreprises. Les
déclarations de diligence raisonnée devront être enregistrées dans cette
interface en amont de la mise sur le marché, la mise à disposition sur le
marché de l'UE ou l'export de produits listés à l'annexe 1 du RDUE.
La Commission européenne a partagé sur son site deux vidéos de présentation du
système d'information avec des explications sur la manière de soumettre une
déclaration de diligence raisonnée. Les instructions d'utilisation de cette
interface devraient également être très prochainement mises à disposition sur
cette page internet.
Les inscriptions seront possibles à partir de mi novembre et le système sera
mis en service le 2 décembre avec la possibilité de soumettre les premières
déclarations.
Nous restons à votre disposition pour toute question.
A la suite de Cosmetic 360,
Andrew JONES, Membre d’UNITIS, vous invite le vendredi 18 octobre matin à
participer à des conférences et échanges à Paris s’articulant autour de deux
thématiques :
Les informations concernant le lieu, l’horaire et le programme vous seront communiquées ultérieurement. N’hésitez pas à nous faire part de votre intérêt pour cet évènement à welcome@unitis.org
Dans le prolongement de notre information du 11 juin 2024 concernant le système d'information européen qui sera utilisé
pour la mise en application du règlement n°2023/1115, dit règlement
contre la déforestation de l'UE (RDUE), nous tenions à vous informer que
la Commission européenne a développé deux applications supplémentaires
pour l'interface de programmation d'applications (API) qui permettront
aux utilisateurs de modifier ou de retirer une déclaration de diligence
raisonnée via l'API.
Les tests de conformité pour ces deux nouvelles applications peuvent
désormais être réalisés, néanmoins ils ne sont pas nécessaires pour
pouvoir se connecter à l'environnement de production.
Les spécifications techniques détaillées (test 5 et test 6) sont également
disponibles sur le site internet Europa où vous pourrez retrouver de
plus amples informations sur le système d'information. Veuillez noter
que les spécifications peuvent faire l'objet de mises à jour.
Vous trouverez ci-joint le
support présenté par le Ministère de la transition écologique ainsi que par le
Commissariat général au développement durable lors d’une réunion organisée le 4
juillet dernier avec l’ensemble des fédérations (UNITIS, FEBEA, INGRECOS,
PRODAROM…).
Cette présentation apporte notamment des réponses aux questions soulevées par
les adhérents de l’ensemble des fédérations.
Pour information, comme mentionné dans la diapositive numéro 9, dans le cadre
du programme européen LIFE, la Commission européenne a publié un nouvel appel à
propositions pour des projets portant sur des priorités législatives et
politiques de l'UE. L'une d'entre elle concerne le renforcement des capacités
et la formation des acteurs du secteur privé pour la mise en œuvre du règlement
contre la déforestation de l'UE (RDUE).
L'objectif de cet appel est de soutenir les efforts des États membres de l'UE
pour sensibiliser les entreprises soumises au RDUE, et plus particulièrement
les PME, et soutenir ainsi la mise en conformité de ces acteurs.
La contribution maximale de l'UE est de 1 million d'euros, avec un taux de
cofinancement maximal de 90 %. La durée prévue du projet est de 36 mois. La
date limite pour la soumission des propositions est le 19 septembre 2024 à
17h00.
Pour plus d'informations, nous vous invitons à consulter le portail des appels
d'offres et des financements de l'UE,
ainsi que la fiche de l'appel LIFE.
Veuillez noter qu'un appui peut être apporté par le ministère de la Transition
écologique et de la cohésion des territoires dans la constitution et le dépôt
d'un projet LIFE (pour en savoir plus : https://www.ecologie.gouv.fr/programme-europeen-financement-life).
Pour toute question, information ou difficulté, n'hésitez pas à nous contacter.
We inform you that the European Commission
published on 1 July 2024 an update of the Rolling List of (groups of)
substances for restriction of REACH Restrictions Roadmap under the Chemicals
Strategy for Sustainability, intially launched in April 2022 (see our
information of 4 May 2022).
The roadmap outlines ongoing efforts and future plans for restrictions under
REACH. It prioritises group restrictions for the most harmful substances to
human health and the environment, in line with the EU’s Chemicals Strategy for
Sustainability.
Consult the Rolling
List of (groups of) substances for restriction updating Annex I to the
Restrictions Roadmap.
Dans le cadre de la mise en
œuvre du règlement n°2023/1115, dit règlement déforestation de l'UE (RDUE), un
système d'information européen va être mis en place par la Commission
européenne. Les déclarations de diligence raisonnée devront être enregistrées
dans cette interface en amont de la mise sur le marché UE, la mise à
disposition sur le marché UE ou l'export de produits listés à l'annexe 1 du
RDUE.
Pour les entreprises souhaitant permettre une interopérabilité entre leur
propre système d'information de suivi de déclarations de diligence raisonnée
(DDR) et le futur système d'information européen, un test de conformité
préalable est requis par la Commission européenne. Ces tests de conformité
peuvent être réalisés depuis le 27 mai 2024, sans date limite.
Vous trouverez ci-après les notes techniques de la Commission ayant vocation à
guider ces tests de conformité :
- EUDR API specifications for Operators - Conformance Test 1,
- EUDR API specifications for Operators - Conformance Test 2,
- EUDR API specifications for Operators - Conformance Test 3,
- EUDR API specifications for Operators - Conformance Test 4.
Elles sont également disponibles sur le site de la Commission européenne qui
est susceptible de les mettre à jour si cela s’avérait nécessaire.
La Commission européenne a par ailleurs précisé que cette série de tests
s'adresse à un public technique car elle nécessite des connaissances
spécifiques relatives à la méthode d'accès fournie et des technologies
associées. Par ailleurs, il est important de comprendre que ces tests de
conformité ne constituent pas une deuxième série de test pilote, comme celui qui
s'est déroulé entre décembre 2023 et janvier 2024.
Le document PDF ci-après détaille quant à lui les spécificités du « format
GeoJason » qui sera le format requis pour les données de géolocalisation :
- EUDR GeoJson File Description.
Plus généralement, vous trouverez ci-dessous le calendrier européen relatif à
la mise en place du système d'information :
- Juillet-Août 2024 : partage de vidéos de présentation
- Septembre 2024 : partage des instructions d'utilisation
- Octobre 2024 : sessions de formation
- Mi Novembre 2024 : ouverture des inscriptions
- 16 décembre 2024 : mise en service du système d'information
Concernant les questions techniques relatives au système d’information, il est
possible de s'adresser à ENV-EUDR-IS-TEAM@ec.europa.eu
Il est également possible de retrouver les informations relatives au RDUE sur
la page dédiée du ministère de la Transition écologique et de la Cohésion des
territoires (MTECT).
UNITIS, en collaboration avec
Ingrecos et la FEBEA, a travaillé sur la rédaction de fiches pays qui visent à
informer des démarches d’accès et de partage des avantages (APA) auprès des
autorités nationales compétentes de chaque pays.
Après la fiche France qui vous a été communiquée le 30 novembre 2023, vous
trouverez ci-joint les fiches du Vietnam et du Mexique. Ces dernières ont été
validées par les autorités nationales compétentes ou par les points focaux.
En tout état de cause, ce document n’a aucune valeur juridique, il ne dispense
pas de consulter les textes et lois officiels mais il est un bon support
d’information.
N’hésitez pas à nous faire part de vos remarques suite à vos expériences.
Consulter les fiches pays Mexique et Vietnam.
UNITIS, en collaboration avec
ASPA-Ingrecos et la FEBEA, a travaillé sur la rédaction de fiches pays qui
visent à informer des démarches d’accès et de partage des avantages (APA)
auprès des autorités nationales compétentes de chaque pays.
L’objectif est de fournir à l’ensemble des acteurs concernés une bonne
compréhension des lois (définitions, champs d’application, procédure d’accès…)
et d’opérer en conformité selon le cadre légal en vigueur.
La première fiche élaborée qui est celle
de la France. Elle a été validée par le Ministère chargé de l’environnement
dans le cadre de notre groupe de travail Ministères/ inter-fédérations.
En tout état de cause, ce document n’a aucune valeur juridique, il ne dispense
pas de consulter les textes et lois officiels.
N’hésitez pas à nous faire part de vos remarques suite à vos expériences.
Consulter la fiche pays France.
Regulation (EU) 2023-1115 of
the European Parliament and of the Council of May 31, 2023 concerning the
placing on the market in the Union and the export from the Union of certain commodities
and products associated with deforestation and forest degradation and repealing
Regulation (EU) n°995/210 was published in the Official Journal of the European
Union (EU) on June 9, 2023.
It is designed to "minimize the EU's share of global deforestation and
forest degradation", as well as to "reduce the EU's share of global
greenhouse gas emissions and biodiversity loss".
It will come into force on December 30, 2024.
The regulation prohibits the marketing or export from the European market of products
that have contributed to deforestation or forest degradation after December 31,
2020.
It directly affects several raw materials used in cosmetics:
The exhaustive list includes : CATTLE, COCOA, COFFEE, PALM OIL, RUBBER, SOYA,
WOOD.
For each commodity concerned, a list of products concerned is detailed
according to EU customs codes.
Products of goods included in the regulation may only be placed on or exported
from the EU market if all the following conditions are met:
- They are deforestation-free;
- They have been produced in accordance with the relevant legislation of the
country of production; and
- They are subject to a due diligence declaration.
Traceability and transparency are therefore at the heart of the scheme, as the
companies concerned (operators and retailers) are obliged to make a reasoned diligence prior to exporting or marketing their product, in order to provide
sufficient information to guarantee that the product carries no or negligible
risk of deforestation.
This declaration is based on 3 elements:
- Information gathering requirements: in particular, companies must geolocate
the plot of land from which the product originates, as well as the date or
period of manufacture.
- Risk assessment, which must be reviewed at least once a year: the companies
concerned must verify and analyze the information gathered, and carry out an
assessment based on defined criteria.
- Risk mitigation measures supplemented by reporting obligations, such as
requesting additional information, data or documents, or carrying out
independent surveys or audits.
>> Please let us know :
- Are you concerned by the products in question, and if so, which ones?
- Would you be interested in setting up a working group on the subject?
UNITIS Flash - September 2023.
The Commission launched a call
for transition initiatives to achieve the green and digital transition of the
EU chemical industry. This call is key to working together with stakeholders to
co-implement the actions highlighted in the Transition Pathway for the Chemical
Industry. These actions aim to strengthen the EU chemical industry’s
competitiveness, reduce its vulnerability to a changing geopolitical landscape
while supporting investments in safe and sustainable chemicals.
The first deadline to submit your transition initiative is 11th October, when
the first stock-tacking will take place. A guidance document is available.
We inform you that the 6th
Omnibus Regulation on CMR substances has been published by Commission Regulation
(EU) N° 2023/1490 of 19 July 2023 (Official Journal of the EU of 20 July 2023)
amending Regulation (EC) N° 1223/2009 of the European Parliament and of the
Council on cosmetic products.
This list of the 31 substances banned in cosmetics results from the Regulation
N°. 2022/692 of 16 February 2022 amending the CLP (see our information of 9 May
2022).
The provisions of this regulation cover, in particular, the inclusion of
Theophylline, Margosa extract and Cumene in Annex II of the European cosmetics
regulation.
This Regulation shall enter into force on the 1st of December 2023.
Le premier guide sur
l’affichage de l’impact environnemental et sociétal des produits cosmétiques,
des compléments alimentaires et des produits de santé familiale et de bien être
destiné à toutes les entreprises, et piloté par le Consortium Green Impact
index, a été publié le 30 juin par l’AFNOR : AFNOR SPEC 2215.
Cet AFNOR SPEC est le fruit de 9 mois de travaux menés par 120 participants
issus de 26 organisations.
L’affichage du score environnemental et sociétal se fera par le biais du Green
Impact Index. Ainsi, grâce à une cotation graduée de A à E, les consommateurs
pourront choisir leurs produits cosmétiques et de bien-être en toute
connaissance de cause.
Ce guide est disponible sur le site de l’AFNOR.
Si vous souhaitez rejoindre le Consortium Green Impact Index : contact@greenimpactindex.com
The last day of the Swedish
Presidency, the EU Council issued its legislative proposal amending the CLP
regulation which provides the deletion of the articles relating to
multi-constituent substances (MOCS) with the following consequence and
provision:
The EU Council proposal should serve as a basis for negotiations with the
European Parliament which are expected to start from October 2023.
To be followed carefully…
We would like to inform you
that a call for data on the safety of Cannabidiol (CBD) in cosmetic products
has been launched by the European Commission on 1st June 2023. This call for
data concerns pure Cannabidiol (CBD) (CAS No. 13956-29-1, EC No. 689-176-3), as
well as extracts that may contain contaminants of other cannabinoids, including
trans-Δ⁹- tetrahydrocannabinol (THC or delta-9-THC) (CAS No. 1972-08-3, EC No.
625-153-6), at trace levels.
Data can be submitted on all physicochemical properties, toxicokinetics and
toxicological endpoints, assessment of exposure through consumer products
and/or an indication of the suggested safe concentration levels for CBD and
safe trace levels of THC, or any other cannabinoid that might be present as a
contaminant is such preparations.
A mandate to the SCCS will follow this request in order to perform a safety
assessment on CBD when used in cosmetic products, as well as on the THC content
that could be deemed safe at trace levels in finished cosmetic products that
contain CBD or other hemp and cannabis-derived ingredients.
Please note the deadline to submit relevant scientific data is 30 September
2024 at the latest.
The SCCS
has just published the 12th revision of its “Notes of Guidance for the Testing
of Cosmetic Ingredients and their Safety Evaluation” (ref. SCCS/1647/22),
adopted during the plenary meeting of 15 May 2023.
This valuable document is designed to provide guidance to public authorities
and to the cosmetic industry in order to improve harmonized compliance with the
current Cosmetic EU legislation.
We do recommend you to read this new version in depth.
You will find hereafter a shortlist of the main changes in this 12th revision
and a link to access the full guidance document :
The Commission delegated
Regulation (EU) 2023/707 of 19 December 2022, amending Annexes I, II, III and
VI of Regulation (EC) 1272/2008, has been published in the Official Journal of
the European Union on 31 March 2023.
In Annex I, this CLP regulation sets out four new hazard classes and criteria
for the classification, labelling and packaging of substances and mixtures as
follows:
- ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
- ED ENV in Category 1 and Category 2 (Endocrine disruption for the
environment)
- PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very
bioaccumulative)
- PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)
This Regulation entered into force on 20 April 2023. From this day on, the
Member States can make proposals for harmonized classification and labelling
(CLH) with the new hazard classes and manufacturers, importers, downstream
users and distributors can self-classify their substances and mixtures
accordingly.
A transitional period should be allowed during which manufacturers, importers,
downstream users and distributors are not yet required to classify their
substances or mixtures according to the new hazard classes. During these
periods, the new hazard classes can be applied on a voluntary basis.
For new substances, the date of application is 1 May 2025 at the latest,
whereas for substances that have already been on the EU market before that
date, companies have until 1 November 2026.
For mixtures, new hazard classes apply from 1 May 2026 at the latest, whereas
companies have until 1 May 2028 to update the classification and labelling for
existing mixtures, i.e. mixtures placed on the market before 1 May 2026.
We inform you that the ECHA’s Member State Committee (MSC) unanimously agreed on the identification as Substances of Very High Concern (SVHCs) of nine hazardous chemicals:
Consult the substances added to the Candidate List for authorization on 17 January 2023.
Dans le prolongement de notre information du 24 novembre dernier
annonçant l’utilisation exclusive de la plateforme européenne DECLARE
NAGOYA pour les dépôts de déclaration de diligence, nous vous apportons
des précisions sur les modalités d’enregistrement.
Pour en savoir plus, consulter le communiqué de presse du Ministère de
l’Enseignement Supérieur et de la Recherche du 8 décembre dernier.
Pour rappel :
> Un guide utilisateur détaillé est accessible sur : https://ec.europa.eu/environment/nature/biodiversity/international/abs/pdf/Question%20and%20answer%20users.pdf
> La vidéo ci-après présente la plateforme DECLARE NAGOYA et les
différentes étapes de l’enregistrement d’une déclaration de diligence : https://audiovisual.ec.europa.eu/en/video/I-193088
> Vous pouvez également visiter la page d’information européenne : https://ec.europa.eu/environment/nature/biodiversity/international/abs/legislation_en.htm
> L’accès à la plateforme se fera via ce lien : https://webgate.ec.europa.eu/declare/web/home
Dans le
cadre de l’application du Protocole de Nagoya, nous vous informons de la
modification des modalités de démarche dématérialisée pour la déclaration de
diligence concernant l’accès aux ressources génétiques et le partage des
avantages (APA).
En effet, à partir du 17 novembre 2022, les utilisateurs qui souhaiteront
déposer une déclaration de diligence concernant des travaux de recherche
financés devront le faire exclusivement sur la plateforme européenne DECLARE
NAGOYA.
Pour en savoir plus, consulter le communiqué de presse du Ministère de
l’Enseignement Supérieur et de la Recherche du 16 novembre 2022.
Ce communiqué est accompagné de liens utiles :
> Une vidéo présente la plateforme DECLARE NAGOYA et les différentes étapes
de l’enregistrement d’une déclaration de diligence : https://audiovisual.ec.europa.eu/en/video/I-193088
> Vous pouvez également visiter la page d’information européenne : https://ec.europa.eu/environment/nature/biodiversity/international/abs/legislation_en.htm
> L’accès à la plateforme se fera via ce lien : https://webgate.ec.europa.eu/declare/web/home
> Enfin, un guide utilisateur détaillé est également accessible sur : https://ec.europa.eu/environment/nature/biodiversity/international/abs/pdf/Question%20and%20answer%20users.pdf
By notification of 9 May, we
sent you the 18th ATP amending Annex VI to CLP, drawing your attention to the
addition, as Reprotoxic Category 2, of Margosa extract/Neem extract (CAS n°
84696-25-3) obtained from the kernels of Azadirachta indica extracted with
water and further processed with organic solvents.
Another natural substance is listed in this 18th ATP as Reprotoxic Cat. 1B, and
may be of concern to you: it is the substance Theophylline -
1,3-dimethyl-3,7-dihy-dro-1H-purine-2,6-dione – (CAS n° 58-55-9).
We remind you that all the substances listed in Annex VI of CLP for their CMR
properties are destined to be banned in cosmetics according to the CMR Omnibus
procedure.
SO PLEASE INDICATE US IF YOU USE ONE OF THESE TWO NATURAL SUBSTANCES AND IF
THEY REPRESENT AN IMPORTANT SHARE OF YOUR MARKET:
- Margosa extract/Neem extract (CAS n° 84696-25-3) obtained from the kernels of
Azadirachta indica extracted with water and further processed with organic
solvents
- Theophylline - 1,3-dimethyl-3,7-dihy-dro-1H-purine-2,6-dione – (CAS n°
58-55-9).
According to your answers, UNITIS might consider the possibility or not to
conduct a collective action to defend these natural substances for their
cosmetic applications.
We inform you that ECHA
opened a public consultation on 11 April 2022 on 11 April 2022 regarding one proposal for Harmonised Classification
and Labelling of propyl 4-hydroxybenzoate (CAS Number: 94-13-3), that
comes from Belgium.
- Consult the CLH report on the matter.
- You can provide your comments by June 10, 2022 with the following link: https://comments.echa.europa.eu/comments_cms/AnnexXVCLH.aspx?RObjectId=0b0236e1858dcd15
The
European Commission launched a public consultation on 20 January 2022 regarding
the revision of the EU Regulation n° 1907/2006 on the Registration, Evaluation,
Authorisation and Restriction of Chemicals.
This revision is one of the 85 actions planned in the framework of the
Chemicals Strategy for Sustainability, adopted by the Commission in October
2020, as the first step towards the “zero pollution” ambition, which is a key
commitment of the European Green Deal.
The aims of this consultation are to take account of stakeholders’ views and
practical experience and gather data to improve their understanding of the
issues at stake.
Should you wish to take part in the consultation, it must be made by 15 April
2022.
Access to the online questionnaire on EU Survey: https://ec.europa.eu/eusurvey/runner/TargetedREACHRevision2022
We inform you that the ECHA’s Member State Committee (MSC) unanimously
agreed on the identification as Substances of Very High Concern (SVHCs)
of four new substances, including 4-MBC used in cosmetics due to its
endocrine disrupting properties for human health.
Consult the substances added to the Candidate List for authorization on 17 January 2022.
The European Commission has
adopted new European Union Ecolabel criteria for cosmetic products and animal
care products by Commission Regulation (EU) 2021/1870 of 22 October 2021 (OJEU
of 26 October 2021).
Although this information relates to finished cosmetic products, we bring it to
your attention.
Previously reserved for rinse-off products, this label is now extended to
cosmetic products as a whole, including leave-on cosmetics, both for private or
professional use, covered under the EU Cosmetic Regulation.
The purpose of the criteria is to promote products that have limited impacts in
terms of eco-toxicity and biodegradability, which may only contain a limited
amount of hazardous substances and that use less packaging, which can be easily
recycled. The use of recycled material and refillable packaging is promoted.
The criteria for awarding the EU Ecolabel to ‘cosmetic products’ are the
following:
- toxicity to aquatic organisms: Critical Dilution Volume (CDV) of rinse-off
products;
- biodegradability of rinse-off products;
- aquatic toxicity and biodegradability of leave-on products;
- excluded and restricted substances;
- packaging;
- sustainable sourcing of palm oil, palm kernel oil and their derivatives;
- fitness for use;
- information on EU Ecolabel.
The EU Ecolabel criteria for the product group ‘cosmetic products and animal
care products’ and the related assessment and verification requirements shall
be valid until 31 December 2027.
For rinse-off cosmetic products that have already been awarded the Ecolabel, the
Commission has established a transition period of 12 months before they have to
meet the new requirements.
Moreover, a transitional period should be allowed for producers whose products
have been awarded the EU Ecolabel for rinse-off cosmetics on the basis of the
criteria set out in Decision 2014/893/EU, so that they have sufficient time to
adapt their products to comply with the new criteria and requirements.
The European Commission
launched a public consultation on 9 August 2021 regarding the revision of the
EU Regulation n° 1272/2008 on Classification, Labelling and Packaging of
chemical substances and mixtures.
This revision is one of the 85 actions planned in the framework of the
Chemicals Strategy for Sustainability, adopted by the Commission in October
2020 as the first step towards the “zero pollution” ambition, which is a key
commitment of the European Green Deal.
For this revision, the Commission will examine, among others, different
measures and options to introduce new hazard classes (such as endocrine
disruption as well as persistency, bioaccumulation and toxicity) and
corresponding classification criteria.
Should you wish to take part in the consultation, responses must be submitted
by 15 November 2021.
Access to the online questionnaire on EU Survey.
Following the publication of
the ISO 16128 standard, UNITIS has been actively engaged with FEBEA and
ASPA-INGRECOS in a project for the certification according to this standard of ORGANIC
and NATURAL cosmetic ingredients under COFRAC accreditation.
The Steering Committee's and the Working Group's work has resulted in the
attached version of a draft standard which takes into account the impossibility
of reproducing the text of the standard in extenso for copyright reasons and
the absolute need to leave no room for ambiguity to obtain accreditation. This
means that clarifications had to be made.
In addition to the formatting work to be carried out in consultation with
COFRAC, the time has come to ask you to send us by 15 September 2021 all your remarks
and comments on the content with the attached Excel template.
The ECHA’s Member State Committee (MSC) unanimously agreed on the identification as substances of very high concern (SVHCs) of eight hazardous chemicals:
- 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers;
- Orthoboric acid, sodium salt;
- 2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA);
- Glutaral;
- Medium-chain chlorinated paraffins (MCCP) (UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17);
- Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/or combinations thereof (PDDP);
- 1,4-dioxane;
- 4,4'-(1-methylpropylidene)bisphenol.
We remind that companies may have legal obligations when their substance is included in the Candidate List and ensure the safe of use of these chemicals. They also have to notify ECHA under the Waste Framework Directive if their products contain substances of very high concern. This notification is submitted to ECHA’s SCIP database and the information will later be published on the Agency’s website.
Consult the substances added to the Candidate List for authorisation on 8 July 2021.
We inform you that ECHA has recently
opened a public consultation regarding a proposal for Harmonised
Classification and Labelling of Sulfur (CAS Number: 7704-34-9), that comes
from France.
- Consult the CLH report on the matter.
- You can provide your comments by September 3, 2021 with the following link: https://comments.echa.europa.eu/comments_cms/AnnexXVCLH.aspx?RObjectId=0b0236e185544484
Omnibus III
Publication
We inform you that the 3rd Omnibus Regulation on CMR substances has been
published by Commission Regulation (EU) 2021/850 of 26 May 2021 amending and
correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No
1223/2009 of the European Parliament and of the Council on cosmetic products,
in the Official Journal of the European Union of 28 May 2021.
In addition to a new list of substances prohibited (Annex II), the provisions
of this regulation cover in particular the addition to Annex III of the
European Cosmetic Regulation of the following substances:
- Salicylic acid, according to the SCCS opinion and its corrigendum of 20-21
June 2019 (ref. SCCS/1601/18);
- Titanium dioxide, according to the draft we sent you last November.
This substance is also added to Annex IV when used as colorant and to Annex VI
when used as a UV filter.
Future Omnibus
The Omnibus IV regulation will be published in the third quarter with the ban
on ZnPT and the procedure for Omnibus V is underway with, in particular, the
SCCS evaluation of Methyl Salicylate and a vote planned for the end of the
year.
The SCCS
recently published the 11th revision of its “Notes of Guidance for the Testing
of Cosmetic Ingredients and their Safety Evaluation” (ref. SCCS/1628/21),
adopted during the plenary meeting of 30-31 March 2021.
This valuable document is designed to provide guidance to public authorities
and to the cosmetic industry in order to improve harmonized compliance with the
current Cosmetic EU legislation.
We do recommend you to read this new version in depth.
You will find hereafter a shortlist of the main changes in this 11th revision
and a link to access the full guidance document. The whole NoG have been
revised and updated with a particular emphasis on the following:
- Inhalation models
- In silico methodology for genotoxicity/carcinogenicity
- General updating of NAMs
- Scientific concerns for the safety of the nanomaterials
- Update of ED section
- Discussion on uncertainty factors
- Updating of references in general
- Appendix 1: complying with the testing & marketing bans
- Appendix 9: guidelines on microbiological quality of the finished product
- Appendix 10: free access to in silico mutagenicity/genotoxicity databases
- Appendix 11: inhalation parameterisation
- Appendix 12: Lifetime Cancer Risk Approach
- Appendix 13: PoD used for TTC derivation.
We inform you that ECHA opened
a public consultation on 15 March 2021 regarding one proposal for Harmonised
Classification and Labelling of 1,2-benzisothiazolin-3-one (BIT), that comes
from Spain.
- CLH report on the matter: 1,2-benzisothiazolin-3-one (BIT).
- You can provide your comments by May 14, 2021 with the following link:
https://comments.echa.europa.eu/comments_cms/AnnexXVCLH.aspx?RObjectId=0b0236e185608e2f
Please find hereafter a
summary relating to the consequences of the judgment recently delivered by the
Court of Justice of the European Union (CJEU) concerning the legal status of
cannabidiol (CBD), in the context of Kanavape Case.
In this case, the CJEU concluded that, in light of current state of scientific
knowledge, CBD, whether obtained as an extract of the cannabis sativa plant or
artificially synthesized, should not be considered as a drug within the meaning
of the Single Convention on Narcotic Drugs of 1961 in so far as it does not
have any psychotropic effect.
Consequently, for the time being, and based on a preliminary conclusion, the
Cosmetics team of the European Commission is of the opinion that CBD
irrespective of its origin should not be considered as a drug and decides, as
regards Cosing, that the entries ‘CANNABIDIOL - DERIVED FROM EXTRACT OR
TINCTURE OR RESIN OF CANNABIS’ and ‘CANNABIDIOL - SYNTHETICALLY PRODUCED’ will
be amended and the reference to the prohibition (entry II/306 to the Cosmetics
Regulation) will be removed.
REMINDER: Cosing must be considered, as it is described by the European
Commission, as a purely indicative inventory with no legal value and does not
constitute a list of substances authorised for use in cosmetic products. An
ingredient assigned with an INCI name that appears in the inventory section of
Cosing does not mean it is to be used in cosmetic products nor approved for
such use. It is why the European Commission also warns that a possible call for
data aimed at collecting information on the safety of CBD in cosmetic products
might be envisaged prior to a potential safety assessment from the SCCS
(Scientific Committee for Consumer Safety).
European Union (EU) has
proposed a ban on Aloe vera extracts and other botanical extracts containing
hydroxyanthracene (HAC) derivatives used as food supplements because of EFSA’s
concerns on genotoxicity and carcinogenicity (Draft (EC) 1925/2006 regulation revision).
The basis for this is:
“Aloe extracts have also been shown to be genotoxic in vitro most likely due to
hydroxyanthracene derivatives present in the extract. Furthermore, aloe-emodin
was shown to be genotoxic in vivo. The whole leaf aloe extract and structural
analogue danthron were shown to be carcinogenic.” EFSA further “was unable to
provide advice on a daily intake of hydroxyanthracene derivatives that does not
give rise to concerns for human health”. “
You will find below the link to EFSA scientific opinion:
URL: http://www.unitis.org/fichiers/intranet-unitis/unitis-technical-files/hazardous-and-cmr-substances/efsa-scientific-opinion-safety-of-hydroxyanthracene-derivatives-for-use-in-food-22-11-2017.pdf
Currently, the proposed ban concerns only the food sector, but it could later
extend to the cosmetic sector.
In this context, we would like to consult you about your Aloe vera extracts and
other botanical extracts containing HAC derivates in order to identify the
impact of a possible adaptation to cosmetic products.
All transmitted data will be anonymized.
You will find below the link to the consultation document, which we invite you
to send back:
URL: http://www.unitis.org/fichiers/intranet-unitis/unitis-technical-files/hazardous-and-cmr-substances/consultation-on-hydroxyanthracene-derivatives-in-botanical-extracts-for-cosmetic-applications-following-a-proposed-ban-in-the-food-supplements-field.docx
Thanking you in advance for your contributions on this matter.
Please find hereafter a summary concerning the draft “Omnibus III” being part of the European
Commission (EC) Cosmetics Working Group discussion in which Unitis
participated. This draft aimed at transposing into the Cosmetics Regulation,
the CMR classification. It concerns Titanium dioxide (Tio2) in particular.
Please
note that there is presently work in progress on analysis of the trade of
frankincense, or species of the genus Boswellia within the framework of CITES
(Convention on International Trade in Endangered Species of Wild Fauna and
Flora).
This project was discussed at the last CITES CoP in August 2019 and two papers
were submitted. In this context, a survey is part of it, commissioned by the
CITES Management Authority of Switzerland and Liechtenstein, the Member for
Europe of the CITES Plants Committee, and is a first step in a larger project
to assess the biology, conservation and trade in this genus. We draw your
attention that this project is just an information gathering exercise and so
that it is by no means certain that any species will subsequently be CITES
listed.
In case your company utilizes frankincense or species of the genus Boswellia,
thank you for taking the time to complete survey you will find below. Please
note that the two papers are linked in the introduction of this survey.
Responses to the survey must be submitted by 22 November 2020.
We inform you that ECHA opened
a public consultation on 19 October 2020 regarding 2 proposals for Harmonised
Classification of Benzyl alcohol, and Silver (nano and non-nano), that
respectively come from Germany (cf. our information of 24 October 2019) and Sweden.
Please find hereafter the CLP reports on the matter:
>> Benzyl alcohol (Annex),
>> Silver.
You can provide your comments by December 18, 2020 with the following links:
>> Benzyl alcohol,
>> Silver
Germany has recently submitted to ECHA a dossier on the benzyl alcohol
substance (CAS n° : 100-51-6) for the following proposed harmonised
classification and labelling:
• Acute toxicology 4, H302
• Eye irritation 2, H 319
• Skin sensitisation 1B, H317
Anyone with relevant information is encouraged to provide it to the
dossier submitter during the early stages of the process, or at the
latest during the public consultation.
We inform you that the ECHA’s
Member State Committee (MSC) unanimously agreed on the identification as
substances of very high concern (SVHCs) of four new substances, including Butyl
4-hydroxybenzoate (Butylparaben) due to its endocrine disrupting properties for
human health. This endocrine-disrupting substance is used in consumer products,
such as cosmetics.
We remind that companies may have legal obligations when their substance is
included in the Candidate List - either on its own, in mixtures or in articles.
Any supplier of articles containing a Candidate List substance above a
concentration of 0.1 % weight by weight has to give sufficient information to
their customers and consumers to allow safe use. As of January 2021, companies
will also need to notify ECHA’s SCIP database if their articles contain
Candidate List substances.
Another substance – Resorcinol – could be identified as an SVHC too. The REACH
Committee of the European Commission will take a final decision within a few
months.
Consult the substances added to the Candidate List for
authorisation on 25 June 2020.
The European Commission
published on July 18, 2019 an updated notice to stakeholders regarding the withdrawal
of the United Kingdom and EU rules in the field of cosmetic products.
UK and EU have agreed to delay Brexit until October 31, 2019. In case of a
no-deal, the United Kingdom will be as of 1 November 2019 a third country. This
means that new rules will apply for cosmetic products placed on the EU market
as of the withdrawal date.
Please find the EU notice highlighting the consequences of the UK's
withdrawal in the field of cosmetic products.
As a reminder, last year the
subsidiary of a Member company – located in China – has been unable to send to
France samples of crushed dry plants on the basis that the plants were
considered to be Traditional Chinese Medicine (TCM). The existence of this
Chinese customs restriction was then confirmed repeatedly to UNITIS by two
Chinese express shipping companies (regardless of the quantity and form: seeds,
dry plants, roots…). As a matter of fact, the mention of this restriction is
listed on Chinese customs’ official website but its publication is not a recent
one.
Consequently, UNITIS continued the investigations and tried to verify this
information from other different sources – public and private – without any
conclusive results, as they are partly contradictory.
Following a new inquiry, FEDEX CHINA stated last week that:
> “Normally, Chinese customs allow the export of plants considered as
Traditional Chinese Medicine if they are sent from Guangzhou. If they are
crushed into powder, the sender should provide a certification for transport of
the goods in order to certify that they are safe for flight.”
> “If the Traditional Chinese Medicine is sent from Shanghai, the shipment
may not be cleared by customs.”
Therefore, the above-mentioned Member company is likely to request a new
shipment of samples from its Chinese subsidiary for verification, as the
situation is quite confusing.
Of course, we will let you know about any upcoming news.
Should you have any valuable information on that matter or, if you face any
similar problems with China, please inform us at the following e-mail address: sbrangier@unitis.org
Please note that the shipment from China of any TCM herbs and plants is strictly prohibited by the Chinese Customs.
This restriction, recently confirmed to UNITIS by two express shipping companies located in China, applies regardless of the quantity (i.e. including samples) and form (seeds, dry plants, roots…).
In case you need to check if a plant you are interested in falls under the TCM category you can consult the following database : https://theory.yinyanghouse.com/theory/herbalmedicine/tcm_herbal_medicine_database (the research must be made using the Chinese name of the plant).
If necessary, please note that UNITIS has also the possibility to get in touch with a Chinese contact person who is in charge of the Traditional Chinese Medicine Integrated Database (TCMID 2.0) which, unfortunately, is currently facing some technical problems and cannot be consulted online until further notice.
The French Ministry recently launched on-line ABS procedures (declaration and request for authorization) for the access to genetic resources collected on the French territory and the fair and equitable sharing of benefits arising from their utilization.
The Ministry stated in its communication that those on-line ABS procedures apply to “non-domesticated animal species” and “non-cultivated botanical” genetic resources.
> Declaration
Legal entities: https://www.demarches-simplifiees.fr/commencer/apa-declaration-pmorale
Private persons : https://www.demarches-simplifiees.fr/commencer/apa-declaration-pphysique
> Request for authorization
Legal entities: https://www.demarches-simplifiees.fr/commencer/apa-autorisation-pmorale
Private persons: https://www.demarches-simplifiees.fr/commencer/apa-autorisation-pphysique
Detailed information on ABS procedures in France can be obtained on the website of the Ministry.