What will be the year 2021? Keep these dates in mind!

New regulations will come into force, such as the IFRA 49, the marking of wet wipes, or the banning of several cosmetic ingredients, in particular HICC, Atranol, Chloroatranol… In addition, 2021 will also see the official recognition of Titanium Dioxide as a carcinogen agent, or the continuation of the safety assessment of ingredients classified as endocrine disruptors or nanos, with possible consequences on the continued use of these ingredients in cosmetics.



January 1st: Brexit


As of today, the United Kingdom officially leaves the European Union with a Free Trade Agreement and becomes a “third country.

Brexit will have implications in all companies without exception! For the cosmetic industry, these include the location of the Responsible Person and the Product Information File, product notification, qualification of the safety assessor, REACH registrations, new customs rules and their impact on supply and distribution chains, etc.


Responsible Person


Cosmetic products placed on the UK market will need a responsible person established in the United Kingdom.

Cosmetic products placed on both in the EU and UK market will need a Responsible Person for both EU and UK markets.



Labelling


Name and Address of the Responsible Person

If the product is sold on the UK market, the name and address of the UK responsible person will need to be placed in the labelling of the cosmetic product.

If the cosmetic product is sold in both the UK and EU market, both EU and UK responsible persons have to appear on the label of the product.


Country of origin

In accordance with Regulation 1223/2009, the country of origin shall be specified for imported cosmetic products from a third country.

If the product is manufactured in the UK and placed on the EU market, the United Kingdom will be the country of origin and should be indicated on the product label.

The same applies to a product which is manufactured in the EU and placed on the UK market - the EU will be the country of origin and should be indicated on the product label, as well.


Country of origin

In accordance with Regulation 1223/2009, the country of origin shall be specified for imported cosmetic products from a third country.

If the product is manufactured in the UK and placed on the EU market, the United Kingdom will be the country of origin and should be indicated on the product label.

The same applies to a product which is manufactured in the EU and placed on the UK market - the EU will be the country of origin and should be indicated on the product label, as well.


Notification

Products placed on the UK market will need to be notified on a new UK notification system.

Cosmetic products placed on both EU and UK markets will need to be notified in both CPNP and UK notification system.

Related articles:

Brexit's Impact on Cosmetics




January 4th


End of consultation period for the SCCS preliminary Opinions on Propylparaben and Homosalate


On the basis of the safety assessment of Propylparaben, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that propylparaben is safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %.


For further information:

Scientific Committee on Consumer Safety (SCCS) Opinion on Propylparaben


On the basis of safety assessment of Homosalate, and considering the concerns related to potential endocrine disrupting properties, the SCCS has concluded that Homosalate is not safe when used as a UV-filter in cosmetic products at 11 concentrations of up to 10%. In the SCCS’s opinion, the use of Homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 1.4% Homosalate in the final product.


For further information:

Scientific Committee on Consumer Safety (SCCS) Opinion on Homosalate



End of consultation period for the SCCS preliminary Opinions on Hydroxyapatite (nano), Copper (nano) and Colloidal Copper (nano)


Having considered the data provided, and other relevant information available in scientific literature, the SCCS cannot conclude on the safety of the Hydroxyapatite composed of rod–shaped nanoparticles for use in oral-care cosmetic products, because the available data/information is not sufficient to exclude concerns over the genotoxic potential of HAP-nano.


For further information:

Scientific Committee on Consumer Safety (SCCS) Opinion on Hydroxyapatite (nano)


The SCCS is of the opinion that it is not possible to carry out safety assessment of the nanomaterials Copper and Colloidal Copper due to the limited or missing essential information.


For further information:

Scientific Committee on Consumer Safety (SCCS) Opinion on Copper (nano) and Colloidal Copper (nano)




February 15th


End of consultation period for the SCCS preliminary Opinions on Benzophenone-3 and aluminium compounds in lipsticks


On the basis of safety assessment, and considering the concerns related to potential endocrine disrupting properties of Benzophenone-3 (BP-3), the SCCS has concluded that:

a. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in sunscreen products, either in the form of body cream, sunscreen propellant spray or pump spray, is not safe for the consumer.

b. The use of BP-3 as a UV-filter up to a maximum concentration of 6% in face cream, hand cream, and lipsticks is safe for the consumer.

c. The use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation is safe for the consumer.


In the SCCS’s opinion, the use of BP-3 as a UV filter in the following sunscreen products is safe for the consumer up to a maximum concentration of:

a. 2.2% in body creams, in propellant sprays and in pump sprays, provided that there is no additional use of BP-3 at 0.5% in the same formulation for protecting the cosmetic formulation.

b. Where BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, in propellant sprays and in pump sprays.


For further information:

Scientific Committee on Consumer Safety (SCCS) Opinion on Benzophenone-3


In the light of the new data provided, the SCCS considers that the use of aluminium compounds is safe at the following equivalent aluminium concentrations up to:

· 6.25% in non-spray deodorants or non-spray antiperspirants

· 10.60% in spray deodorants or spray antiperspirants

· 2.65% in toothpaste and

· 14% in lipstick (instead of 0.77% in its previous Opinion)


For further information:

Scientific Committee on Consumer Safety (SCCS) Addendum to the scientific opinion SCCS/1613/19 on the safety of aluminium in cosmetic products (lipstick) - Submission II


2nd quarter (no definite date yet)


Projected date for the adoption of the draft Regulation Deoxyarbutin / Dihydroxyacetone


The proposed Regulations provide for the prohibition of Deoxyarbutin and restrictions of Dihydroxyacetone in non-oxidative hair dyes and self-tanning products.


For further information:

Draft Commission Regulation (EU) …/… of XXX amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


Draft Commission Regulation (EU) …/… of XXX amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products – Annex



Projected date for the adoption of the draft Regulation CMR3


This draft Regulation foresees the addition of 12 new entries in Annex II (prohibited substances) of Cosmetics Regulation 1223/2009, and two amendments to Annex III (restricted substances), to add Titanium Dioxide and to modify the restriction on Salicylic Acid.


For further information:

Draft Commission Regulation (EU) …/… of XXX amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


Draft Commission Regulation (EU) …/… of XXX amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products – Annex



May 10th


Entry into force of the IFRA 49


The 49th Amendment to the IFRA Standards was published on 10 January 2020.

IFRA members had first until 10 February 2021 to comply with the new Standards for new fragrance creations, and until 10 February 2022 for existing creations. But following the crisis due to Covid-19, IFRA has granted an additional period of three months to comply, respectively until 10 May 2021 for new creations and until 10 May 2022 for existing creations.



June 3rd


Entry into force of part of Regulation 2020/1682


From this date, products containing HEMA or Di-HEMA Trimethylhexyl Dicarbamate and not complying with the new restriction applicable to these substances can no longer be placed on the Union Market.


For further information:

Commission Regulation (EU) 2020/1682 of 12 November 2020 amending Annex III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products



Entry into force of part of Regulation 2020/1683


From 3 June 2021, after mixing under oxidative conditions, the maximum concentration applied to the hair of Dimethylpiperazinium Aminopyrazolopyridine HCl and Methylimidazoliumpropyl p- Phenylenediamine HCl must not exceed 2% (calculated as a free base).

Tetrabromophenol Blue as a hair dye substance in non-oxidative hair dye products from this date is limited to a 0.2% maximum concentration in ready-use preparation. After mixing under oxidative conditions, the maximum concentration applied to the hair of Tetrabromophenol Blue must not exceed 0.2% (calculated as a free base).

In addition, the maximum concentration of HC Orange No 6 and Acid Orange 7 in ready-use preparations is limited to 0.5%.

Indigofera Tinctoria Leaf, Indigofera Tinctoria Leaf Powder, Indigofera Tinctoria Leaf Extract and Indigofera Tinctoria Extract as a hair dye substance in non-oxidative hair dye products from this date is limited to a 25% maximum concentration in ready-use preparation


For further information:

Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products



July 3rd


Entry into force of part of Regulation 2020/2151


From this date, in order to reduce the impact of certain plastic products on the environment the packaging of wet wipes with the surface area of 10 cm² or more must be marked to inform the consumers of the presence of plastic in the product.


For further information:

Commission Regulation (EU) 2020/2151 of 17 December 2020 laying down rules on harmonised marking specifications on single-use plastic products listed in Part D of the Annex to Directive (EU) 2019/904 of the European Parliament and of the Council on the reduction of the impact of certain plastic products on the environment



August 23rd


Definitive ban on HICC, Atranol and Chloroatranol


From this date, cosmetic products containing HICC, Atranol or Chloroatranol shall not be made available on the Union market. These allergenic substances were already banned in products placed on the market since 23 August 2019. All products containing these substances must be withdraw from the market before 23 August.


For further information:

Commission Regulation (EU) 2017/1410 of 2 August 2017 amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


September 3rd


Entry into force of part of Regulation 2020/1682


From this date, products containing HEMA or Di-HEMA Trimethylhexyl Dicarbamate and not complying with the new restriction applicable to these substances cannot be made available on the Union Market.


For further information:

Commission Regulation (EU) 2020/1682 of 12 November 2020 amending Annex III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products



Entry into force of part of Regulation 2020/1683


From 3 September 2021, hair and eyelash dye products containing 1,2,4-Trihydroxybenzene, 4-Amino-3-hydroxytoluene or 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid can no longer be placed on the Union Market.


For further information:

Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


October 1st


Implementation of the 14th ATP of CLP


The delegated Regulation (EU) 2020/217 covers a total of 6 cosmetic ingredients, including Titanium Dioxide, which officially becomes a category 2 carcinogen by inhalation.


For further information:

Commission Delegates Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation

December 3rd


Entry into force of part of Regulation 2020/1683


From 3 December 2021, products containing Dimethylpiperazinium Aminopyrazolopyridine HCl, Methylimidazoliumpropyl p- Phenylenediamine HCl or Tetrabromophenol Blue must be labelled with the mixing ration as well as the conditions of use and warnings defined in the Regulation.


For further information:

Commission Regulation (EU) 2020/1683 of 12 November 2020 amending Annexes II and III to Regulation (EC) No.1223/2009 of the European Parliament and of the Council on cosmetic products


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