News

EXTENDED ALLERGENS LABELLING AS PER ANNEX III AMENDMENT OF EU REGULATION (EC) 1223/2009

Published on 27 October 2023


REGULATORY BACKGROUNG

On July 27th, 2023, the European Commission published a new amendment to the EU Cosmetics Regulation (EC) 1223/2009. This amendment is in line with the Scientific Committee on Consumer Safety (SCCS) final Opinion of 26th-27th June 2012 and introduces an additional 56 fragrance allergens due to potential risks to human health.

The amendment proposes an obligation to label individually those fragrance allergens whose concentration exceeds:

  • 0,001 % in leave-on products
  • 0,01 % in rinse-off products

These cut-off levels are the same as the labelling requirements of the 26 allergens introduced via the 7th Amendment to the Cosmetic regulation in 2003.

The regulation entered into force on August 16th, 2023 (20 days after its publication in the EU Official Journal (OJ).

From the into force date the transition period is 3 years for the placing on the EU market and 5 years for the withdrawal from the EU market.

 

WHAT IS THE CURRENT SITUATION AT SOZIO?

There are two steps in the implementation of this new regulation in our systems:

  • Adapting our new certificate in our system (grouping of substances). This is on-going and should be finalised by the end of 2023

  • Updating our Raw Materials following our supplier survey sent to all applicable suppliers earlier this year. We are still awaiting feedback from some, and upon receipt we will complete our database in a timely manner

 

Once our new data model is up and running, by the end of the year, we will be able to start issuing the extended allergens certificate (80+) for our fragrances. However, please note that our allergens data may evolve in the future following new information from our suppliers in line with the transitional arrangements.

Regarding briefs for new development fragrance projects with a requirement on allergens, we will consider the extended allergens list. However, the allergens levels in the fragrance might change as we receive feedback from our raw materials suppliers.

 

A NATURAL FRAGRANCE WITHOUT ALLERGENS OR LABELLED ON THE FINISHED COSMETIC PRODUCT : AN UNREALISTIC DREAM?

Working with these two requirements is unlikely to be achievable and will have a high olfactive impact. Indeed, the extended list of allergens contains natural extracts, eg Orange oil, Bergamot oil, Rose extracts, Lavandula/ Lavandin, Cinnamon, Cedarwood, Ylang. It also contains numerous substances naturally present in Extracts and used as Natural ingredients, such as Linalyl acetate (Lavandula, Bergamot) or Beta Caryophyllene (Cinnamon, Ginger).

These two requirements together will reduce the raw material palette available to our perfumers. However, playing with the fragrance dose/load and using specific natural isolates and molecules may help to achieve this goal. Our perfumers will strive to make your dreams come true even when facing the most difficult challenges.

 

TO CONCLUDE

Considering the extensive transition period and the data gathering process, we are working to provide an extended allergens certificate as soon as possible (hopefully by the end of the year), and we will communicate our ability to do so in due course.

Additionally, it will be more complex to have fragrances/finished products without allergens or with a limited number of allergens depending on the olfactive note. This is a challenge for both the fragrance houses and the cosmetic product manufacturers, but our perfumers will support our customers in this effort.

 

FOLLOW UP

If you need any further information about the extended list of allergens, please reach out to us via email: regulatory@jesozio.com, or through your designated Sales Representative.

 

 


VERSION 4.0 OF THE COSMOS STANDARS

Published on 3 August 2023


Main evolutions impacting COSMOS certified and approved fragrance compounds

 

CONTEXT

The COSMOS standards related to Organic and Natural cosmetics is an internationally recognized European standard. It was developed by 5 founding members: BDIH (Germany), COSMEBIO (France), ECOCERT (France), ICEA (Italy) and SOIL ASSOCIATION (United-Kingdom).

Version 4 (v4) of the COSMOS standards was published on 1st January 2023 and entered into force on 1st June 2023.
The transitional measures have been adjusted since the 1st June 2023 and will be integrated into the next version 4.1 of the COSMOS standards:

  • New raw materials (fragrance compounds and their ingredients) submitted for certification (COSMOS CERTIFIED) or an approval (COSMOS APPROVED) from 1st June 2023 must comply with v4 of COSMOS standards.
    Raw materials certified/approved before 1st June 2023 to v3 of the COSMOS Standards have until 1st December 2024 to comply with the new v4.
  • Personal Care products submitted for certification after 1st June 2024 must comply with v4 of the COSMOS standards. Cosmetic products that have been certified before 1st June 2024 according to v3 of the COSMOS standards can still be manufactured and have until 1st December 2025 to comply with v4.

 

COSMOS STANDARDS

The COSMOS certification of organic and natural cosmetics guarantees the respect of human health, biodiversity and environment by:

  • Promotion of the use of products from organic agriculture
  • Responsible use of natural resources
  • Integration and development of the concept of green chemistry
  • Selection of appropriate manufacturing and processing processes
  • Absence of Genetically Modified Organisms (GMO’s)
  • Absence of irradiation
  • Absence of the majority of nanomaterials

 

The complete v4 of the COSMOS standards is available via the following link: cosmos-standard_v40.pdf

This standard is private and certification requires a commitment to an independent and COSMOS accredited certification body: CERTIFY COSMETICS WORLDWIDE | COSMOS International Certification Bodies (cosmos-standard.org)

To be eligible for COSOS certification, all personal care products must first comply with the regulations in force relating to personal care products (cf. point 2. REGULATIONS of the standard).

 

MAIN EVOLUTIONS OF THE COSMOS STANDARDS V4

The main evolutions in v4 of the COSMOS standards impacting on fragrance compounds are as follows:

  • For all products and all raw materials (single or in mixture), the palm oil and its derivatives (point 7.4 of the standard) must be certified organic or sustainable to the following standards: RSPO, SAN, RSB or UEBT. The minimum RSPO certification level required is the Mass Balance (MB) supply chain model.
  • For all COSMOS CERTIFIED perfumes and COSMOS ORGANIC certified personal care products, 24 new plants have been added to the list of Physically processed agro-ingredients (PPAI) that must be organic (point 7.1.1 of the standard), available in Appendix VI of the COSMOS standards.
    Examples of new plants that must be organic: Cinnamon, Citronella, Cypress, Eucalyptus, Geranium, Lemongrass, Mint, Orange, Patchouli, Tea tree, Thyme, Ylang Ylang, etc.
    Certification according to an Organic Agriculture regulation (CE, NOP, JAS or equivalent), regrouped within the IOFAM Family of Standards or according to other internationally recognised organic standards (example: COSMOS) are accepted.
  • For the Physically processed agro-ingredients (PPAI), the primary raw materials, and particularly those from the « coconut » sector, must not be harvested/collected by threatened species listed in the IUCN red list (IUCN Red List of Threatened Species) (point. 6.1.3 of the standard) belonging to the categories Critically Endangered (CR), Endangered (EN) and Vulnerable (VU).
    Specific transitional measures: The criteria on threatened species must be met before 1st December 2024.
  • Promotion of sustainable packaging (point 8.3 of the standard) : This criterion is applicable to primary and secondary packaging of finished personal care products and certified raw materials (of which the COSMOS CERTIFED/APPROVED fragrances are part of).
    Each sales unit must comply with a minimum of 3 indicators, from a minimum of 2 different principles among the 4R’s: Reduction / Reuse / Renewable / Recycle.
    The continuous improvement of the packaging is to be carried out at least every three years, and particularly in the monitoring of quantities of packaging used in relation to the number of products. It is the aim to reduce the quantities of packaging used.
    Specific transitional measures: These criteria on packaging must be met before 1st June 2025 (if the submission date is before 1st June 2024).

 

INGREDIENTS

Among the five categories of ingredients defined by the COSMOS standard, the Physically processed agro-ingredients (PPAI), and the Chemically processed agro-ingredients (CPAI) are the main ingredients used in the formulation of fragrance compounds.

In addition to the new criteria relating to v4 of the COSMOS standards described above, the PPAI and CPAI ingredients must be guaranteed non-GMO, respect the requirements of the Convention of International Trade in Endangered Species of Wild Fauna and Flora (CITES), and not be obtained from primary raw materials extracted from living or slaughtered animals. They must come from authorized physical or chemical processes (cf. Appendices I and II of the standard).

Other ingredients are authorized and listed in Appendix V of the standards: Preservatives and ethanol denaturants from petrochemical origin, ingredients containing both natural origin and petrochemical moieties, or agro-ingredients extracted with petrochemical solvents such as Absolutes, Concretes, and Resinoids which are only accepted in COSMOS NATURAL certified cosmetics.

 

CERTIFICATIONS OF PERSONAL CARE PRODUCTS

According to the COSMOS standard, there are two levels of certification for finished personal care products and the criteria are summarized below:

  • Certification « COSMOS NATURAL »:
    – No minimum required for organic ingredient content
    – 2% maximum of petrochemical moieties in the finished product

  • Certification « COSMOS ORGANIC » :
    – 20% minimum of organic ingredients in the finished product
    (Exemption : 10% minimum of organic ingredients for rince-off products, non-emulsified aqueous products and products with at least 80% minerals or ingredients of mineral origin)
    – At least 95% of the PPAI’s must be organic
    – PPAI’s present must be organic if they are listed in Appendix VI of the standards
    – CPAI’s present and listed in Appendix VII of the standard must be organic: Organic certified Ethyl Alcohol
    – 2% maximum of petrochemical moieties in the finished product

NB: The specific rules for these labels and ingredients are fully explained in the COSMOS standards. Here, we talk about the requirements only applicable to the design of a fragrance compound according to this standard.

 

SOZIO PROVIDES NATURAL AND ORGANIC CERTIFIED PERFUMES THAT MEET THE REQUIREMENTS OF THE COSMOS STANDARDS

SOZIO is committed to the certifying bodies ECOCERT Greenlife and SOIL ASSOCIATION 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 fragrances according to the COSMOS standards, but also Essential Oils (EO) or mixtures of EO’s certified as organic according to Regulation (EU) 2018/848. Our certificates and attestations are provided upon request.

To date, SOZIO has performed the necessary checks of its ingredients with ECOCERT/SOIL ASSOCIATION, and can offer perfumes that comply with v4 of the COSMOS standard.

For any new brief for including 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 in the fragrance with the proportions in PPAI/PPAI BIO/CPAI/CPAI BIO will be necessary for the creative development.

 

FOLLOW UP

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


EU REACH – DRAFT REGULATION ON MICROPLASTICS HAS BEEN APPROVED

Published on 6 June 2023


The latest version of the draft regulation on microplastics has been approved at the REACH Committee meeting on 26th – 27th April 2023.

 

CONTEXT

The experts representing the different Member States have approved the draft restriction on microplastics. This is the 7th version of the text since the initial draft was circulated on 5th September 2022. This version was released on 2nd May 2023. The draft must then pass through the Parliament and Council. It should be published in Q3/2023.

 

CONTEXT OF THE TEXT

The proposed restriction covers intentionally added polymers in all consumer and professional use products. Synthetic polymer microparticles shall not be placed on the market as substances on their own or, where synthetic polymer microparticles are present to confer a sough-after characteristic, in mixtures in a concentration equal to or greater than 0.01% by weight.

 

Reminder of the definition :

Synthetic polymer microparticles are polymers that are solid and which fulfill both of the following conditions:

  1. Are contained in particles and constitute at least 1% by weight of those particles, or build a continuous surface coating on particles
  2. At least 1% by weight of the particles referred to in point (a) fulfill either of the following conditions :
    • All dimensions of the particles are equal to or less than 5mm
    • The length of the particles is equal to or less than 15mm and their length to diameter ratio is greater than 3

 

EXCLUSIONS AND EXEMPTIONS

The following are excluded from the definition of synthetic polymers :

  1. Polymers that are the result of a polymerisation process that has taken place in nature, independently of the extraction process, and that are not chemically modified substances
  2. Polymers that are degradable, as proven in accordance with appendix [X] (see text of the appendix: 5 tests are detailed, with at least the need to meet the conditions of one of the first 3 tests)
  3. Polymers with a solubility of more than 2g/L, as proven in accordance with Appendix [Y] (see text in the Appendix: tests are those of OECD 105 or OECD 120)
  4. Polymers that do not contain carbon atoms in their chemical structure

 

Certain exemption criteria are defined in the case where releases to the environment are controlled. Some of these are particularly applicable to cosmetics. Criteria for exemption from the restriction of the maximum threshold of 0.01% by weight:

Criterion 4:

  1. Synthetic polymer microparticles for use on industrial sites

 

Criterion 5:

  1. Synthetic polymer microparticles which are contained by technical means so that releases to the environment are prevented when used in accordance with the instructions for use during the intended end use
  2. Synthetic polymer microparticles, the physical properties of which are permanently modified during intended end use in such a way that the polymer no longer falls within the scope of this entry
  3. Synthetic polymer microparticles which are permanently incorporated into a solid matrix during intended end use

 

LABELING AND REPORTING REQUIREMENTS

  • As a raw material supplier (suppliers of synthetic microparticle polymers), for users on industrial sites

LABELING: 24 months after the date of entry into force of this amending Regulation, suppliers of synthetic polymer microparticles exempted by criterion 4a (industrial site) shall provide the following information:

a) Instructions for use and disposal, explaining to industrial downstream users how to prevent releases of synthetic polymer microparticles into the environment

b) The following statement: “The synthetic polymer microparticles supplied is subject to conditions laid down by entry [entry number specified after publication] of the Annex of Regulation (EC) 1907/2006 of the European Parliament and of the Council”

c) Information on quantity or, as applicable, concentration of synthetic polymer microparticles in the substance or mixture

d) Information on the polymers contained in the substance or mixture

e) Information on the polymers contained in the substance or mixture that enables downstream users and other suppliers to comply with their respective obligations

Information to be provided on the SDS or packaging/notice, in a clear, legible, indelible way, possibly in the form of a pictogram, and in a dematerialized way.

 

REPORTING: 36 months after the date of entry into force, manufacturers must submit the following to ECHA before 31st May of each year:

a) Description of the uses of synthetic polymer microparticles in the previous year

b) For each use, an estimate of the quantities of synthetic polymer microparticles released into the environment in the previous year, including transport

c) For each use a reference to the derogation (criterion 4a)

 

  • As a user on an industrial site

REPORTING: 36 months after the date of entry into force, industrial downstream users using synthetic polymer microparticles at industrial sites must submit the following to ECHA by 31st May of each year:

a) Description of the uses of synthetic polymer microparticles in the previous year

b) For each use an estimate of the quantities of synthetic polymer microparticles released into the environment in the previous year, including transport

c) For each use a reference to the derogation (criterion 4a)

 

  • As supplier of product placing product on the market

LABELING: 24 months after the date of entry into force, suppliers of products containing synthetic polymer microparticles shall provide instructions for use and disposal explaining to professionals or the general public how to avoid the release of microparticles into the environment.

Information to be provided in a clear, visible, legible and indelible manner, possibly in the form of a pictogram, on the packaging or the leaflet, and in a dematerialised form.

 

REPORTING: 36 months after the date of entry into force, suppliers of products placed on the market for the first time for professional use or the general public must submit the following to ECHA before 31st May of each year:

a) The description of the end uses of synthetic polymer microparticles placed on the market in the previous year

b) For each end-use, the identity of polymers placed on the market in the previous year

c) For each end-use for which synthetic polymer microparticles were placed on the market, an estimate of the quantities of these microparticles released into the environment in the previous year, including transport

d) For each use, a reference to the applicable derogation (e.g. 5ab, b, or c)

The information must be made available to the authorities on request. The regulation also defines deadlines for the communication of data within the supply chain.

 

DEADLINES
For cosmetics, the transition periods are…

    • 4 years for rinsed cosmetic products
    • 6 years for non-rinsed cosmetic products
    • 12 years for lipsticks, nail polish, and make-up (with labelling after 8 years on the presence of microplastics)

 

For synthetic polymer microparticles encapsulating fragrances, the transition periods of 5 or 8 years may both be appropriate in terms of their economic costs and their economic benefits.

For detergents, waxes, polishes and air care products, a transitional period of 5 years was considered appropriate to give the industry sufficient time to reformulate their products and substitute synthetic polymer microparticles.

The deadlines concern both placing and availability on the market and making available on the market.

 

FOLLOW UP

If you need any further information about the future regulation on microplastics, please reach out to us via email: regulatory@jesozio.com, or through your designated Sales Representative.