News

USA : THE LONG-AWAITED COSMETIC REGULATION MAJOR UPDATE HAS BEEN SIGNED !

Published on 11 May 2023


CONTEXT

Modernization of the Cosmetic Regulation Act of 2022 (MOCRA) has been signed into law as part of the inclusion of the Consolidated Appropriation Act by President Biden on 29 December 2022.

This is the most significant update of the US Federal Food, Drug and Cosmetic Act (FDCA) since its introduction in 1938.

MOCRA includes new provisions for cosmetic products. It enhances the Food and Drug Administration (FDA) regulatory jurisdiction and enforcement of cosmetics by granting the FDA authority to order a mandatory recall of a cosmetic product, and access to company and cosmetic product dossiers.
Our regulatory experts have reviewed this new law, and we present below the main anticipated changes and upcoming deadlines!

 

MOCRA’S KEY PROVISIONS

MOCRA introduces new provisions, including for cosmetic company registration, product listing, record keeping, adverse events reporting, safety substantiation, Good Manufacturing Practices (GMP), and recalls. All of these changes are set out in sections 605-611 of this law.

 

  • Section 605 – Serious Adverse Event Reporting and Record keeping

Manufacturers need to submit a report to the FDA within 15 days in the case of a “serious adverse event”. Additionally, for one year after the initial submission, the responsible person must submit to FDA within 15 business days of receipt any new and material medical information related to the initial report.

The responsible person must maintain records related to each report of an adverse event associated with the domestic use of a cosmetic product for six years. Certain small businesses only have to maintain such records for a period of three years.

 

  • Section 606 – Good Manufacturing Practices (GMP)

MOCRA requires the FDA to establish GMP’s to protect public health and ensure that cosmetic products are not adulterated. The FDA is required to promulgate a proposed rule for GMP’s for cosmetic manufacturing and processing facilities by December 2024. By December 2025, the final rule for GMP’s will be published, including simplified GMP requirements or longer compliance timelines for small businesses.

Furthermore, the FDA may promulgate regulations that would allow the Agency to inspect records necessary to demonstrate compliance with GMP.

 

  • Section 607 – Facility Registration and Product Listing

MOCRA requires the registration of existing facilities that manufacture or process cosmetics for distribution in the United States by 29 December 2023. For new facilities, registration is mandatory within 60 days of the start of the activity.
Facilities that solely perform labelling, relabelling, packaging, or repackaging of cosmetic products are not required to register with the FDA. The same applies for facilities that only manufacture ingredients and not finished products, and facilities with the sole purpose of carrying out research and development activities.

The responsible person must also list each cosmetic product, including its ingredients, with the FDA no later than December 29, 2023. A flexible system must allow for the grouping of different versions of the same product in a single submission.

For products placed on the market after 29 December 2023, the responsible person must submit the product listing within 120 days of the market placement. Additionally, the responsible person must update product listing information annually.

 

  • Section 608 – Safety Substantiation

A responsible person must ensure and maintain records supporting that there is adequate substantiation of safety of the cosmetic product.

 

  • Section 609 – Labelling Requirements

Cosmetic product labels must include a national address and national telephone number or electronic contact details (which may include a website), through which the responsible person can receive an adverse event report concerning a cosmetic product.
The labelling of cosmetic products for professional use must include a clear and visible statement indicating that the product is administered or used only by authorised professionals and complies with existing labelling requirements for cosmetic products.

Fragrance allergens, based on the list that will be proposed by the FDA no later than June 2024, will also have to appear on the label according to their application type criteria and concentration level in the finished product. We expect the allergen labelling rules to be the same as those applicable in Europe.

 

  • Section 610 – Cosmetic Products Dossiers

If the FDA determines with reasonable probability, that a cosmetic is adulterated or misbranded, it can access the cosmetic product dossier.

 

  • Section 611 – Mandatory Recall

MOCRA grants the FDA the authority to request a voluntary recall of a cosmetic product if the Agency determines that there is a reasonable probability that the product is adulterated or misbranded, and the use of, or exposure to the product, will cause serious adverse health consequences or death. If the responsible person does not comply with the FDA’s request, the FDA can order a mandatory recall after providing the responsible person an opportunity for an informal hearing.

 

GET READY FOR THE NEXT DEADLINES !

tableau article

MOCRA is the culmination of more than a decade of negotiations and effort. The passage of MOCRA will help to ensure the safety of cosmetic products and increase consumer trust in products that are a part of daily life.

 

If you need any further information about ECOCERT and COSMOS standards, please reach out to us via email: regulatory@jesozio.com, or through your designated Sales Representative.


SOZIO GROWTH OVER THE LAST FIVE YEARS

Published on 16 March 2023


“During the last 5 years, Sozio has grown exponentially with double-digits increases every year and the company has seen its turnover triple. This growth can be explained by two factors, internal and external, through the acquisition of 2 new fragrance companies Scentessence in France and Phoenix Fragrances in the UK and the opening of 6 new Sales offices or Laboratories abroad which allow our development teams to be closer to our customers. Indeed, we completed our existing network os sales offices in Canada, Israel, Germany and Philippines with the opening of offices in Dubai, Poland, Spain, Algeria, Nigeria, and Vietnam.

We have considerably increased our production capacities in our 7 factories worldwide (Piscataway, New Jersey-USA, Noyant- France, Wellinborough-UK, Chartres-France , Hong- Kong, Jakarta-Indonesia and very soon the opening of a new factory  in China) to better serve our customers and reduce our leadtimes.

The company has also diversified its activity, especially in the ingredients sector with the acquisition of Synarome , a leading producer of specialties for the fragrance industry.

 

These years have also witnessed the growth of natural perfumery and thus Sozio’s role within this sector. Today, more than 10% of Sozio’s turnover comes from its expertise in natural formulation due to our large palette of natural / Cosmos certified ingredients and the savoir-faire of our 25 perfumers worldwide , also specialized in Fine fragrances, Personal Care, Home fragrances and Household products.

 

With targeted sales of 100 ms€ in 2023, Sozio is still driven by the « artisan mind » of the founders 265 years ago, and now the savoir-faire of our creative teams, the proximity to our clients and the agility of our logistical centers worldwide.

I would like to deeply thank our 3,000 long time existing or new clients, but moreover our 350 employees who are giving all their energy and enthusiasm to offer the best creativity and the best service as possible and sustain Sozio’s growth.

2023 will be again a new year full of passionate events with various developments and challenges that we will share in the next coming months !”

 

Frederic Braud, Sozio General Manager

 


NEW ECOCERT STANDARD – NATURAL DETERGENTS AND NATURAL DETERGENTS MADE WITH ORGANIC VERSION 6

Published on 1 February 2023


The sixth version of the ECOCERT natural detergents standard was published in May 2022, and entered into force on 1st August 2022. From 1st August 2023, all products certified according to this standard and their labelling must comply with this new version.
The ECOCERT Natural Detergents certification for cleaning products is an internationally recognized environmental label. It guarantees respect for the environment throughout the production process, the use of ingredients of natural or organic origin, and the prohibition of most petrochemical ingredients.
In this latest version, the new requirements for finished products ensure:

  • More precision on naturalness, and greater restrictions on synthetic ingredients
  • A safer product with the addition of new prohibited risk phrases on finished products
  • More commitment from companies on environmental management
  • A guarantee of effectiveness on the main function of the finished product

The complete standard is available following this link: Ecocert Greenlife standard for Natural Detergents made with Organic 2022
This standard is private, and certification requires a commitment to an independent certification body such as ECOCERT.

In order to be eligible for ECOCERT natural detergent certification, all cleaning products must first comply with the regulations in force relating to detergent products (see Foreword – V. The regulatory bases on page 9 of the standards document via the link above).

 

TWO LABELS

According to the ECOCERT natural detergent standard, there are two levels of labelling for detergent products:

  • Label « Natural detergents » :

ecodetergent

> No minimum requirement about % of organic ingredients

> The labelling elements set out in Appendix V of the ECOCERT natural detergents standard are not permitted on the finished product

 

The Sixth version of the ECOCERT natural detergents standard has extended the list of prohibited hazard statements on finished products certified “Natural detergents”. In addition to environmental hazards, hazard statements for certain physical hazards (explosive, gases under pressure) and human health hazards (toxic, carcinogenic, mutagenic, reprotoxic) are now prohibited. The complete list of hazard statements and their prohibition is available in Appendix V of the standard.

  • Label « Natural detergents made with organic » :

eco detergent bio

> 10% minimum of organic ingredients in the finished product

> No hazard statement is allowed on the finished product

 

INGREDIENTS

ECOCERT distinguishes different types of ingredients according to their nature, origin or function.

For natural origin ingredients, the main prerequisites are that they are guaranteed non-GMO and not listed in the appendices of the CITES Washington Convention (or benefit from CITES import/export control permits and certificates). They must come from authorised physical or chemical processes (see Appendix III of the standard).

Petrochemical solvents are not allowed for extraction processes, except in special cases (see Appendix I.A.5 of the standard). As a result, Absolutes and resinoids are prohibited.

Synthetic ingredients, derived from petrochemicals, are prohibited in the finished product, except for a list of authorised ingredients (see Appendix I of the standard) that includes ethanol denaturants, preservatives, etc.

Organic certified ingredients according to an Organic Agriculture regulation (CE, NOP, JAS or equivalent), or a recognized private standard (Cosmetics or Natural detergents of ECOCERT Greenlife or COSMOS) are accepted.

Only fragrances with natural origin ingredients are allowed.

NB: The rules specific to these labels and ingredients are fully explained in the ECOCERT Natural Detergent standard. We talk about the requirements only applicable to the design of a fragrance composition according to this standard.

 

SOZIO PROVIDES NATURAL FRAGRANCES THAT COMPLY WITH THE NEW VERSION OF THE ECOCERT NATURAL DETERGENTS STANDARD

SOZIO is committed to the certifying bodies ECOCERT Greenlife according to the COSMOS standard, and ECOCERT France according to the European Organic Agriculture (AB) 2018/848 regulation.
These commitments allow SOZIO to offer 100% natural fragrances that are approved or organic certified according to the COSMOS standard, but also Essential Oils (EO) or mixtures of EOs certified as organic according to Regulation (EU) 2018/848. Our certificates and attestations are provided on request.

These natural fragrances, their raw materials and these EOs, meet the requirements relating to the ingredients mentioned above and are directly approved by ECOCERT. They are recognized and fully accepted in detergent products certified “Natural Detergent” or “Natural Detergents made with organic” according to version 6 of the ECOCERT standard.

To check compliance of fragrances and EOs with version 6 of this standard, we need to ensure that at the intended load/dosage, the fragrances do not bring additional hazard statements that are prohibited on the finished Natural Detergent products.

We remain at your disposal to check the compliance of the fragrances we provide to your company according to version 6 of the ECOCERT Natural Detergent standard.

For any new brief for a fragrance compliant with this new standard, the nature of the label, the fragrance load/dosage in the finished product, and the percentage of organic ingredients required from the fragrance will be necessary for the development.

 

If you need any further information about ECOCERT and COSMOS standards, please reach out to us via email: regulatory@jesozio.com, or through your designated Sales Representative.

 

Please note that all the newsletters published in 2022 are available on request:

  • The new EU Ecolabel criteria for cosmetics and animal have been released!
  • The Washington State Toxic-Free Cosmetics Act
  • Methyl-N-methylanthranilate: new conditions of use
  • Consultation on the 51st Amendment to the IFRA Standards
  • Vegan certifications for cosmetic and household products
  • China’s New Cosmetics Regulation (CSAR)