Regulatory updates since the “Congrès Parfums & Cosmétiques 2022”

For its 20th anniversary, the “Congrès Parfums & Cosmétiques” organized by Cosmetic Valley welcomed 600 professionals from the beauty industry in Chartres on November 23 & 24, 2022. It is an emblematic annual meeting where manufacturers and reference authorities share all their questions related to regulatory affairs in the beauty sector. Together, let's go through the main cosmetic news from the conferences but also their most recent evolutions.

Allergen labeling in fragrances

On September 15, 2022, the European Union transmitted to the World Trade Organization a draft update of the European Cosmetic Regulation concerning an evolution of the labeling of fragrance allergens in cosmetic products. It aims to extend the number of mandatory allergenic substances to be listed on the label of products. It will add 56 additional substances to the 24 already mandatory (Lilial and Lyral are now prohibited). 

This means that 82 allergens could now be compulsorily labelled in the near future (57 chemical substances and 25 natural extracts).

What does this mean?

Their presence will have to be indicated when their concentration exceeds :

• 0.001% in non-rinsed products (perfumes, creams, oils...)
• 0,01 % in the products to be rinsed (shampoos, shower gels...)

The objective is to ensure and reinforce the safety of consumers in terms of knowledge of the risks to their health.

Important dates: 

This major change could be voted on during the 2nd quarter of 2023.

The deadlines for compliance are short: 3 years for products placed on the market; 5 years for those that have been placed on the market before the new labeling provisions become applicable.

A major stumbling block to be faced: the characterization of each allergen is currently only possible for a part of these allergens. It is therefore not yet possible to ask suppliers to update their declarations on the ingredients or raw materials concerned (mainly perfumed concentrates) and therefore to update your DIP, labeling... 

To be followed very closely in 2023.

Initiatives for the protection of the environment: EcoBeautyScore, Royal Decree in Spain and European project on packaging and packaging waste

Faced with consumers who demand greater transparency regarding the origin of products and their environmental impact, initiatives are multiplying, taking shape or coming into force.

EcoBeautyScore

In order to enable consumers to make sustainable and informed purchasing choices, whether for conventional or organic/natural cosmetics, key players in the cosmetics industry including Henkel, L'Oréal, LVMH, Natura & Co and Unilever have come together to develop a clear and effective rating system: the EcoBeautyScore. This consortium gathers today more than 60 members and is based on a common rating mechanism and a harmonized presentation for consumers.

Today, the members are working on the various projects of the Consortium, in particular the footprint and scoring methodology, the development of the tool and the means of communication.

Royal Decree in Spain

At the national level, following Italy's lead with the amended packaging law no. 116/2020, Spain is taking a leap forward. After months of proposals and amendments, Royal Decree 1055/2022 on packaging and packaging waste has been published.

This decree thoroughly revises the packaging law, which has been in force for more than 20 years, setting specific targets and measures for packaging manufacturers, distributors and administrations, with adaptation to current European requirements.

The main innovations include measures to: 

• prevent packaging waste
• encourage bulk sales of foodstuffs
• increase the reuse of packaging and the recyclability and recycling of packaging.

European project on packaging and packaging waste

At the European level, a draft law on packaging waste is also being prepared.

You want to know more? Feel free to read our dedicated article, or contact our experts via this contact form

New Chinese regulations - focus on the submission of safety data for raw materials

Florence RICAUD, Secretary General and Technical Manager of ASPA-INGRECOS and Anna ÖST, International Regulatory Affairs Director of AMOREPACIFIC EUROPE gave an overview during the Perfumes and Cosmetics 2022 congress on the operational implementation of the new Chinese regulation (CSAR), applicable since January 1st, 2021. This new regulation fully replaces the previous regulation of 1989.

It is again recalled that CSAR distinguishes between ingredients listed on the IECIC, also called "existing ingredients" and those that are not, "new cosmetic ingredients".

The system for collecting information on the safety of existing ingredients is currently being implemented.

 The big question: who should notify existing ingredients?

⇒ Manufacturers of new cosmetic ingredients: they fill in the information of their ingredients on the Chinese platform and get a submission number to send to their customers. 

⇒ Manufacturers or brand owners of cosmetics using new cosmetic ingredients: they receive the information in Annex 14 from the raw material manufacturer. 

Some have already started to communicate the safety information of their ingredients. 

Please note that the website is only available in Mandarin: https://zwfw.nmpa.gov.cn/web/index

Important dates:

• Since January 1, 2022, existing ingredients that belong to the category of preservatives, sunscreens, colorants, hair dyes, stain control agents and whitening agents, qualified as "high risk", will have to be accompanied by extensive safety information in accordance with Annex 14; 
• From January 1, 2023, other existing ingredients, qualified as "low risk", will also have to present comprehensive safety information in accordance with Annex 14.

Faced with these regulatory challenges, EcoMundo can assist you in the complete submission of raw material data [Annex 14] with all standard documents (MSDS, IFRA, allergen certificate) to the NMPA (National Medical Products Administration)

[EcoMundo can help you register and file your cosmetic products in China via a unique service offering: 

• Category check ("special" and "general")
• Registration of a "general" cosmetic product
• Registration of a cosmetic product "special
• Review of ingredients, claims and packaging for compliance with Chinese regulations
• Provision of a checklist and sample documents, including review and guidance on how to properly complete registration documents
• Preparation and submission of NMPA application package.
• Close monitoring and prompt response throughout the filing/registration process
• Delivery of the NMPA certificate
• Advice on applicable legislation and relevant regulations]

Point of attention: 

Foreign companies must designate a Cosmetic Responsible Agent (CRO) before marketing in China.

Several options are available to you:

• Setting up a Chinese subsidiary
• Selection of a distributor in China
• Mandate a third party in China, such as a consulting firm

Note that each option has risks and benefits, especially in terms of controls and security.

Prerequisite:

• Legal address in mainland China
• Have a qualified person to assume and implement the responsibilities

Responsibilities:

• Assist the brand in post-market adverse event monitoring
• Assume responsibility for quality and safety, implement product recalls 
• Communicate with local authorities in case of contro

United States - Cosmetic Regulatory Modernization Act Regulation Act (MoCRA)

After 84 years of status quo, the US cosmetics regulation is getting very strong.

On December 29, 2022, the American authorities signed the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). 

This amendment focuses on product safety. The industry will now be subject to :

• Registration requirements for cosmetic products and establishments
• The provision of safety assessments
• Labeling
• Regulated substances
• Cosmetovigilance
• Good Manufacturing Practices (GMP)
• The designation of a Responsible Person

These major updates are to be followed very closely.

Important dates: 

• FDA facility registration will be mandatory by 2024
• New companies will have 60 days after the start of manufacturing to complete this process
• If you have registered under the Voluntary Cosmetic Registration Program (VCRP), you may be covered for the initial registration. However, cosmetic product registrations must be updated annually. New products must be registered within 120 days of their introduction into commerce.
• Facility registrations must be renewed every two years

Assessment of the controls and campaign of the DGCCRF

The DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) continues to conduct numerous control campaigns concerning cosmetic products.

In 2022, the controls focused on 5 main themes:

1. Claims "with", "hypoallergenic", "sensitive skin" and environmental

2. An operation named "clean market" on CMR and other regulated substances Observation: Increased presence of cosmetic products containing Butylphenyl Methylpropional or Lilial, very popular for its floral notes evoking lily of the valley. This substance is prohibited since 01/03/2022 

3. Nanomaterials

Observation : Lack of labeling of the nano character and non-respect of specific limits.

Reminder: according to Article 2 of the Cosmetic Regulation n°1223/2009, a nanomaterial is defined as "an insoluble or biopersistent material, intentionally manufactured and characterized by one or more external dimensions, or an internal structure, on a scale of 1 to 100 nm".

A. Only 5 substances in nano form are currently listed in the Annexes of the European Cosmetic Regulation. Titanium dioxide, zinc oxide, MBBT, tris-biphenyl triazine and carbon black

B. No preservatives are authorized in this form. 

4. Cosmetic product containing hemp derivatives: hemp leaves and flowers become authorized.

The Council of State ruled on December 29, 2022 on the order of January 30, 2021. It will no longer be forbidden to market and consume raw hemp leaves and flowers. The use of these raw ingredients in cosmetic and food products can be expected to accelerate.

5. Cosmetic products for professionals only  

The investigations focused on 4 areas: Labeling; Composition; Claims; Misleading commercial practice.

In 2023, the DGCCRF wants to focus on the control of claims on the composition of cosmetic products, nanomaterials, sunscreen products but also the Product Information File (PIF). 

It still happens very often that companies present to the authorities an incomplete or even non-existent PIF. In addition, there is the absence of declaration or update of the CPNP, non-compliance of the labeling and the presence of substances without the corresponding warning.

EcoMundo can assist you with label verification and PIF compliance. Contact us

>> 6 key steps to export a cosmetic product to Europe and the UK: Download the infographic

_{How EcoMundo can help you secure your regulatory compliance}

The name EcoMundo has become a guarantee of conformity for cosmetic products and perfumes.

Flexibility 

EcoMundo teams go beyond standard compliance services and adapt to specific cases, thanks to the ability to anticipate changes and a proactive knowledge of the latest regulatory updates (specific analysis of environmental claims, sorting instructions, AGEC law ...)

Expertise 

EcoMundo is specialized in the verification of labels and the preparation of PIFs (elements that are often the object of non-conformities during controls or elements that most often drive the attention of regulatory controls).

Efficiency 

In the continuity of its expert services offered since 2007, EcoMundo has developed a SaaS PLM software, COSMETIC Factory, which benefits from all the scientific expertise of our in-house PhD team: toxicologists, ecotoxicologists and chemists.

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