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Regulatory Updates

Biweekly Updates of Global Regulations on Cosmetics (June)
Publication date:2023-06-05

Australia Published New Assessment Statements for Cosmetic Ingredients

On 30 May 2023, the Australian government published a list of new chemical assessment statements for the following cosmetic ingredients.

Chemical Ingredients

GeneralizedEnd Use

Summary of Assessment

Oils, sandalwood, santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-glucose, oxidized

Fragrance ingredients in fine fragrances, cosmetics, and household products

• Imported up to 1 tonne per year

• Household products at a concentration up to 0.02%

• Cosmetics at a concentration up to 0.1%

• Fine fragrances at a concentration up to 0.18%

• Air care products at a concentration up to 2%

 

Benzene, 1-(2-methylpropyl)-4-(propoxymethyl)-

Fragrance ingredients in fine fragrances, cosmetics, and household products

• as a fragrance component imported into Australia at up to 1 tonne per annum

• imported as a component of liquid fragrance formulations at up to 10% concentration, for local reformulation into finished cosmetic and household products

• imported or formulated as a component of finished cosmetic and household products

up to:

o 0.03% concentration in non-spray deodorant

o 0.1% concentration in leave-on cosmetic products

o 0.2% concentration in fine fragrances

o 0.4% concentration in hair care products

o 0.6% concentration in rinse-off cosmetic and household products

o 5% concentration in air care products

 

Acetic acid, 2-cyano-2-[3-[(3-methoxypropyl)amino]-2-cyclohexen-1-ylidene]-, 2-ethoxyethyl ester, (2Z)-

UV filter in cosmetic (secondary sunscreen) products

• as imported into Australia at up to 2 tonnes per year

• as a component of cosmetic (secondary sunscreen) products at a concentration up to 3%

• for use by consumers and professional workers

• as not used in combination with nitrosating substances and the nitrosamine content in

products are less than 50 parts per billion

Benzene, [2-[(2-methyl-1-undecen-1-yl)oxy]ethyl]-

Fragrance ingredients in fine fragrances, cosmetics and household products

• a fragrance component imported into Australia at up to 10 tonnes per year

• imported at up to 100% concentration for local reformulation into finished cosmetic

and household products

• imported or reformulated as a component of finished cosmetic and household

products at less than 1% concentration; except for the following:

o up to 2% concentration in candles

o up to 10% concentration in air care products – both continuous and electrical

table 1

 

EU Revised Use Requirements for Nano Materials

On 23 May 2023, EU SCCS published a draft measure to enact the prohibition to use in cosmetic products certain nanomaterials of health concern. It was previously notified via EU/TBT/872, however, it has been modified to include the prohibition of Colloidal Silver (nano) and the restriction of Hydroxyapatite (nano).

In particular, Annex II (list of prohibited substances in cosmetic products) and Annex III (list of restricted substances in cosmetic products) to the Cosmetics Regulation are amended to uniformly implement within the internal market the prohibition and restriction of the use of nanomaterials for which a basis of concern has been identified and following the recent positive SCCS Opinion on Hydroxyapatite (nano).

The adoption of this draft Regulation is needed to ensure a high level of protection of human health for cosmetic products in the EU.

 

table 1

 

Israel Revised Pharmacists’ Regulations (Cosmetics)

On 15 May 2023, the Israel government released the final version of Pharmacists Regulations (Cosmetics), which eased the requirements in the following aspects:

- Lowers the particular training requirements for responsible representatives so that in the final Regulations, no special training is required to appoint a person as a responsible representative;

- Adds the possibility to report the composition of the cosmetic product in the notification regarding the marketing of a cosmetic product, also in a range of concentrations and not in an exact concentration;

- Lowers the particular requirements regarding the proper storage and transportation of cosmetic products;

- Deletes the special requirements for marking special warnings of cosmetic products;

- Amends the regulations so that the requirement to mark the product according to the regulations applies to the outer or the inner packaging.

table 1

 

UK Released Statutory Guidance to Better Understand the EU and UK Cosmetic Regulations

On 4 May 2023, the UK government released Statutory Guidance to help businesses understand Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market. The purpose of the Regulation is to safeguard public health and establish a fully competitive market.

table 1