Regulatory

Regulatory texts, standards, norms, scientific opinions … today are both numerous and essential in our sector. Cosmetic ingredients must comply with a very high number of requirements, each requiring specific knowledge and in-depth expertise.

Dedicated and expert monitoring

The Miyoshi group is organised around specialised centres of expertise, specialising in local regulations, and globally federated for a common strategy and monitoring. With a strong presence in the sector’s main professional federations, at French and international levels, our objective is to monitor and assess new regulatory requirements. This commitment allows us to be a stakeholder in discussions concerning developments that may impact our products and activities.

Constantly evolving legislation

National and international authorities are constantly updating the texts and requirements applicable to the cosmetics sector, in order to offer end consumers safe solutions, without a negative impact on their health and the environment.
Here at Miyoshi, we are committed to being at the forefront of these developments, and to participating in product offerings that respect multiple requirements, customers and the market, thanks to close collaboration with our Research, Innovation, Marketing and Sales departments.

Support from our partners

Besides regulatory texts, many requirements come from private standards, sector opinions, customer charters and even market trends. At Miyoshi, our desire, as with all of our product offerings, is to provide in-depth expertise on all matters concerning our activity. A real challenge for the future, we support our customers and partners in responding to various regulatory issues in a reliable and efficient manner.
Regulatory obligations can be sources of collaboration between Miyoshi and its partners, thus turning into real opportunities, fully in line with our group’s philosophy of “Treating You Right”.

ABC Regulatory

Regulatory topics are numerous and diverse. They cover a wide range of regulations, even in a given expertise area, so we thought you could find our short ABC below informative ! We covered the main points raised in our day-to-day work, but obviously many other words could be defined. Feel free to reach out to us to add to the list !

ABC Regulatory

Key Word
Definition

A

Animal Testing
Cosmetic Regulation (EC) 1223/2009 prohibits the placing on the market of cosmetic products and ingredients that have been subject to animal testing for cosmetic purpose. The testing ban on finished cosmetic products applies since 11 September 2004. The testing ban on ingredients or combination of ingredients applies since 11 March 2009. Many other countries have adopted such position around the world, and many alternative tests exists nowadays to replace the use of animals for cosmetics toxicological assessment.

C

CLP
Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures : this regulation explains the criteria to classify substances and mixtures according to their physical, health or environmental hazards.
CMR
This category of substances (Carcinogenic, Mutagenic, Reprotoxic) is classified according to criteria defined by GHS local regulation (in Europe : CLP Regulation (EC) No 1272/2008). They are forbidden in cosmetics according to Article 15 of Cosmetic Regulation (EC) No 1223/2009, unless included in any of Annexes 3 to 6 of said regulation. Traces that are technically unavoidable and in spite Good Manufacturing Practices can be tolerated.
CosIng
COSING is the European Commission database containing information on cosmetic substances and ingredients, based on the different sources used (Cosmetic Regulation, Glossary of common ingredients names, SCCS opinions, etc.). It’s updated regularly but does not represents a legal source.
Cosmetic Regulation 1223/2009
Regulation ruling the placing on the European market of cosmetics, what criteria they should respect, what ingredient they can and cannot contain, the restrictions applied to them…
COSMOS
The COSMOS-standard defines the criteria that companies must meet to ensure consumers that their products are genuine organic or natural cosmetics produced to the highest feasible sustainability practices. At ingredients level, the standard allows the approval of ingredients for use in COSMOS certified finished cosmetics. A new version of the standard (V4) will apply to all ingredients from 1 December 2024. One of the new obligations is RSPO certification for ingredients containing palm derivatives.
Cristalline Silica
Crystalline silica is a common mineral found in the earth’s crust. Minerals like talc, silica, mica, etc. can contain a certain amount of crystalline silica. Its classification goes from toxic for specific target organ by repeated exposure (STOT RE 2), to carcinogenic (category 1B by inhalation (European Union) or group 1 (IARC)). Usually, a tolerated content in cosmetics can go up to 1%, as unavoidable traces.
CSAR
Chinese Cosmetic Supervision and Administration Regulation was published on 2021, June 29th for an entry into force on 2022, January 1st. It aims to strengthen the quality and safety of cosmetics by establishing new rules for the marketing of cosmetics, the management of new ingredients, safety assessment, post-marketing surveillance, corporate responsibility, etc. One of the main consequence for cosmetics suppliers is to declare the formula that they place on the Chinese market, through a dedicated platform : composition, ingredients, manufacturers names, risky substances, specification, etc.

E

ECHA
European Chemicals Agency is an agency of the EU. It implements the EU’s chemicals legislation to protect health and the environment.

G

GHS
The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally agreed-upon standard managed by the United Nations. It was created to replace the hazardous material classification and labelling rules used around the world. Its main elements are standardized hazard testing criteria, universal warning pictograms, and harmonized safety data sheets.

H

Heavy Metals
Heavy metals are natural components of the Earth’s crust. They cannot be degraded or destroyed. As trace elements, some heavy metals (e.g. copper, selenium, zinc) are essential to maintain the metabolism of the human body. However, at higher concentrations they can lead to poisoning, mainly because they tend to bioaccumulate. Examples of heavy metals include mercury (Hg), cadmium (Cd), arsenic (As), chromium (Cr), thallium (Tl), and lead (Pb). In cosmetics, this is important to use really pure materials with the lowest possible content in heavy metals.

I

IECIC
IECIC (Inventory of Existing Chemical Ingredient) is a list of existing cosmetic ingredients that have already been used in cosmetics in China. Cosmetic ingredients which are not listed are regarded as new cosmetic ingredients and they require registration or filling before they can be used in cosmetics in China.
INCI
The International Nomenclature of Cosmetic Ingredients (INCI) regroups the unique identifiers for cosmetic ingredients, that are assigned in accordance with rules established by the Personal Care Products Council (PCPC). INCI names often differ greatly from systematic chemical nomenclature or from more common trivial names and is a mixture of conventional scientific names, Latin and English words.
Iron Oxides
Iron Oxides for cosmetics are synthetically manufactured, mainly from recycled materials.These pigments are used to color cosmetic products, and can be red, yellow or black. In Europe, they are known under their color index CI 77491, CI 77492 and CI 77499, and have to respect the purity criteria of Commission Regulation (EU) No 231/2012 on food additives, E172.

M

Microplastics
Microplastics is a widely used term that can have slightly different meaning according to local definitions. In the EU, a new restriction for microplastics has been adopted, banning the use of “synthetic polymer microparticles” from cosmetics at different time horizons according to the type of cosmetics considered (rinse-of, leave-on, make-up, etc.). This is Regulation 2023/2055 of 25 September 2023 amending Annex XVII of REACH Regulation (EC) No 1907/2006.

N

Nanomaterial
Nanomaterial is a term that has had many sligthly different definitions over the last decades. Materials at nanosize are suspected to be of concerned for the human health, and are targeted by several obligations emanating from diverse bodies. In Europe, the current definition of nanomaterials in cosmetic sector is included in the upcoming Cosmetic Regulation revision. The next version should include the definition as worded by the latest European Commission Recommendation of 2022, June 10th.
Naturality
ISO norm 16128 classifies cosmetic ingredients (Natural, Natural-derived, Organic, etc.) and gives the calculation methods to establish four indexes : Natural, Natural Origin, Organic and Organic Origin. The percentages of natural and organic origin of a finished product are derived from the data on its ingredients.

R

REACH
REACH Regulation (EC) No 1907/2006 aims to improve the protection of human health and the environment from the risks that can be posed by chemicals. It is not only for cosmetic ingredients, but for all chemicals.
Its main requirement is that all chemicals entering European market be registered (except exemption), i.e. assessed from toxicological and ecotoxicological points of view.
Another Reach pillar is the restriction of use of chemicals that are deemed at risk for the health or the environment, like for instance microplastics.
RSPO
The Roundtable on Sustainable Palm Oil (RSPO) was established in 2004 with the objective of promoting the growth and use of sustainable palm oil products through global standards and multistakeholder governance. It describes several level of transparency of palm-derivatives supply chains : MB (Mass Balance), SG (Segregated), IP (Identity Preserved), in the order of increasing origin knowledge (up to the mill).

S

SCCS
The Scientific Committee on Consumer Safety (SCCS) provides Opinions on health and safety risks (chemical, biological, mechanical and other physical risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products) and services (e.g. tattooing, artificial sun tanning).Its role is to assess the data provided by the applicant requiring an Opinion, following very thorough guidances.
SDS
A Safety Data Sheet (SDS) is a mandatory document for hazardous products that provides complete information on the composition, physical and chemical properties, health and environmental effects of a substance or mixture. It also contains instructions for the safe handling, use, storage and disposal of the product.
The content and format of SDSs in UE is regulated by the Reach Regulation (EC) No 1907/2006, Annex II, amended by Regulation 2020/878. In particular, it is now mandatory to include the UFI number and to comply with certain requirements relating to nanoforms.

T

Titanium Dioxide
Titanium Dioxide is manufactured from natural ores, and is present in numerous industries (paints, printing inks, plastics, papers, ceramics, building materials, pharmaceutical products, etc.). In cosmetics, it is authorized as a colorant and a UV-filter, under strict criteria. In Europe, as colorant, CI 77891 has to respect the purity criteria of Commission Regulation (EU) No 231/2012 on food additives, E171. As UV-filter, it can be included up to 25% in cosmetics, with additional criteria when present as nanomaterial.

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