EU regulations on ingredients

 INGREDIENTS RESTRICTION AND CRITERIA FOR THE FORMULATION

Ingredients Restriction:Under no circumstances should the following be included during the design and development process:

Ingredients prohibited by current cosmetic legislation

Ingredients in concentrations of use not allowed by the competent legislation in force at the time of design.

As far as possible avoid inputs that come from or are of animal origin (example: collagen (originating from animals), albumin (egg protein), sebum, keratin, lanolin and its derivatives) and definitely not use, those that for your obtaining cause damage or harm to the animal. (Example: placental derivatives, embryos). Considering the exception of ingredients that are by-products of other industries (Example: food industry)

Ingredients not allowed according to the current list of raw materials of the corporation, as well as from suppliers vetoed by the purchasing area. Exceptions should be reviewed with the purchasing area.

The following ingredients:

Aluminum powder

TEA, DEA,

AMP (Aminomethyl Propanol) (Potential sources of nitrosamine formers). Note: It can only be used if there is no other viable alternative for its replacement, (Example: neutralizing in alcohol gel).

Parabens (isopropylparaben, isobutylparaben, filalparaben, benzylparaben, pentylparaben, propylparaben, ethylparaben, methylparaben and butylparaben).

Formaldehyde, formaldehyde donors, Toluene, Toluene / Formaldehyde resin for enamels formaldehyde (methylene glycol / methanediol / formaldehyde)

Formaldehyde donor and formaldehyde donor preservatives (DMDM hydantoin, diazolidinylurea, midazolidinylurea, methenamine, quaternium 15).

Colorants CI 51319 y CI 73915.

Benzophenone 3

Butylhydroxyanisole (BHA).

Phthalates (Phthalatedibutylated (BPD phthalates), bis (2.ethylhexyl) phthalate (DEHP)) (Risk of carcenogenicity and endocrine disruption).

Cyclic silicones D4

Cyclic silicones D5 in rinse off products, as it is restricted in rinse products, but can be used in leave on products, eg: lipsticks.

Polyethylene microgranules.

Triclosan and Triclocarban (Environmental Risk).

Methylisothiazolinone (MIT), Methylchloroisothiazolinone (MCIT)

Titanium Dioxide. Only for products that go to the United States as provided by California Proposition 65, as well as for breathable products.

Halogen donors: bromoderivatives: Bronopol and Bronidox.

As far as possible, avoid the use of other ingredients questioned or included in the regulatory threats not described in the previous point (although it be approved). Example: Phenoxyethanol (which should not exceed 0.4% if used in children under 3 years).

Must be verified (when applicable), absence of preservatives described in points 1.1.5 and 1.2 in new raw materials, even so, the supplier does not declare them in the INCI name.

If any of the ingredients mentioned here is required in its use for a formula design, as long as it does not have a viable replacement and is required to make a superior benefit feasible and does not fail to comply with the maximum allowed dose, its use should be validated with the Chemical ID Management and with the Safety Assessment team. Likewise, it must be included in the risk management of the associated project.

Limits for products containing 1,4 Dioxane (mainly ethoxylates) should be verified, due to the restriction that exists for cosmetic and personal care products containing 1,4-dioxane in order to help prevent contamination of the Water.:

The limit is lowered to 1 ppm (finished product) for personal care products.

The limit is lowered to 10 ppm (finished product) for all other cosmetic products.

In the possible not to use ingredients that by legislation generate an additional payment, tax or financial detention for Belcorp. Example: Use of ingredients from Brazilian Biodiversity protected by legislation.

 

General Recommendations

To design a formula you must have clarity of the concept and the required / expected claims.

Before conducting the Market Research tests, the acceptance criteria must be defined according to the scope agreed for the product with the brand, or the area of application. At the end of the test, its compliance must be verified according to the criteria defined at the beginning.

It should be included in the Brief to INVERA that a filter is made of the users who participate in the HUT evaluations to avoid having people who present some skin imbalance or who do not comply with the skin and / or hair characteristics for which it was designed the product.

Have clarity of the benchmark (reference market product) with an evaluation of the required cost of the product by cost of the benchmark. In the case of an innovative product, look for market products in the same category.

Perform analysis of competitor or benchmark products to have an indication of the physicochemical properties and definition of the required parameters.

Health Authorities and Reference Organizations:

Review Annex AN-00930 " GUIDE FOR USE OF INGREDIENTS"