Commission Regulation (EU) 2021/850 was published on May 28, 2021 to uniformly implement the prohibition and restriction of CMR substances within the internal market. Annex II, Annex III, Annex IV and Annex VI to Cosmetic Regulation (EC) 1223/2009 will therefore be updated.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 100/21

 SG 10021 Chemical

In response to the carcinogenic, mutagenic, or toxic (CMR) classification of certain substances in Regulation (EU) 2020/217, Commission Regulation (EU) 2021/850 is published on May 28, 2021, to uniformly implement the prohibition and restriction of CMR substances within the internal market. Annex II, Annex III, Annex IV and Annex VI to Cosmetic Regulation (EC) 1223/2009 will be therefore updated.

Commission Regulation (EU) 2021/850 of May 26, 2021 amending and correcting Annex II and amending Annex III, IV, and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

(A) 
The following substances are classified as CMR in Delegated Regulation (EU) 2020/217. Without any request for use in cosmetic products by way of exception in Article 15(1) of (EC) 1223/2009, these substances are therefore added into the prohibition list in cosmetic regulation.

The prohibition will be applied from October 1, 2021. 

SG 10021 Table1_Final

(B)
Titanium Dioxide (in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10µm) is classified as Carcinogen Category 2 (inhalation) in Delegated Regulation (EU) 2020/217.

A request for its use in cosmetic product as an exception was submitted. 

With the conclusion of SCCS/1617/20 opinion on Titanium dioxide (TiO2) published on October 6, 2020, the use of Titanium Dioxide (in powder form containing 1% or more of particles with aerodynamic diameter of ≤10µm) shall be allowed only in face products in loose powder form and in hair aerosol spray products. Its restriction is therefore added into Annex III to (EC) 1223/2009. The new restriction will be applied from October 1, 2021. 

Changes New
Annex III
No. X
Substance
Identification
Chemical 
name/INN
Titanium dioxide in powder form 
containing 1 % or more of particles 
with aerodynamic diameter ≤ 10 μm
INCI name Titanium Dioxide
CAS no. 13463-67-7/1317-70-0/1317-80-2
EC no. 236-675-5/215-280-1/215-282-2
Restrictions Product type,
Body parts

(a) Face products in loose powder form
(b) Hair aerosol spray products
(c) Other products
Max. 
concentration
in ready for
use preparation

(a) 25%
(b) 1.4% for general consumers and 1.1% 
for professional use
Other (a), (b)
Only in the pigmentary form
(c) 
Not to be used in applications that 
may lead to exposure of the end-user’s 
lungs by inhalation’
Wording of conditions
of use and warnings

The use of Titanium Dioxide in Annex VI as a UV filter should therefore be allowed without prejudice to its restricted use under Annex III.

This update will be applied from October 1, 2021.

Changes Update
Annex Vi
No. 27'
Substance
Identification
Chemical
name/INN
Titanium dioxide
INCI name Titanium dioxide
CAS no. 13463-67-7/1317-70-0/1317-80-2
EC no. 236-675-5/215-280-1/215-282-2
Restrictions Product type,
Body parts


Max.
concentration
in ready for
use preparation

25%(4)
Other

Titanium dioxide in powder form 
containing 1 % or more of particles 
with aerodynamic diameter ≤ 10 μm, 
to be used in compliance with 
Annex III, No [321]. 

For the product types under letter 
(c) of column (f) in Annex III, No [321], 
the maximum concentration in ready for use 
preparation provided in column (g) of
this entry applies.

Wording of conditions
of use and warnings

The use of Titanium Dioxide in Annex IV as a colorant should therefore be allowed without prejudice to its restricted use under Annex III.

This update will be applied from October 1, 2021.

Changes Update
Annex IV
No. 143'
Substance
Identification
Chemical
name
Titanium dioxide
CI number 236-675-5
CAS no.
EC no. 236-675-5/215-280-1/215-282-2
Color White
Restrictions Product type,
Body parts


Max.
concentration
in ready for
use preparation


Other Purity criteria as set out in 
Commission Directive 95/45/E (E 171)

Titanium dioxide in powder form containing
1% or more of particles with aerodynamic 
diameter ≤ 10 μm, to be used in compliance
with Annex III, No [321]
Wording of conditions
of use and warnings

(C)
To align with the SCCS/1601/18 opinion published on June 20-21, 2019, entry of Salicylic acid in Annex III is therefore updated to include the following product types: body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant with a maximum authorized concentration of use at 0.5%. 

This update will be applied on the 20th day following its publication.

Changes Update
Annex III
No. 98'
Substance
Identification
Chemical
name/INN
Benzoic acid, 2-hydroxy-
INCI name Salicylic acid
CAS no. 69-72-7
EC no. 200-712-3
Restrictions Product type,
Body parts

(a) Rinse-off hair products
(b) Other products except body lotion, 
eye shadow, mascara, eyeliner, lipstick, 
roll-on deodorant
(c) Body lotion, eye shadow, mascara,
eyeliner, lipstick, roll-on deodorant
Max.
concentration
in ready for
use preparation

(a) 3.0%
(b) 2.0%
(c) 0.5%
Other

(a), (b), (c) 
Not to be used in preparations for 
children under three years of age

Not to be used in applications that may lead 
to exposure of the end-user’s 
lungs by inhalation

Not to be used in oral products

For purposes other than inhibiting the
developmentof micro-organisms 
in the product. 

This purpose has to be apparent from the 
presentation of the product

These levels are inclusive of any use 
of salicylic acid.

Wording of conditions
of use and warnings
(a), (b), (c)
Not to be used for children under
three years of age

(D)
The prohibition entry of Nickel bis(tetrafluoroborate) was introduced twice by error. Entry 1427 will therefore be removed. 

This update will be applied on the 20th day following its publication. 

Changes Keep Delete
Annex III II
Reference No. 1401 1427
Substance
Identification
Chemical 
name/INN
Nickel bis(tetrafluoroborate) Nickel bis(tetrafluoroborate)
CAS No. 14708-14-6 14708-14-6
EC No. 238-753-4 238-753-4
Restrictions Prohibited Prohibited

References

  1. Commission Regulation (EU) 2021/850
  2. Commission Delegated Regulation (EU) 2020/217
  3. SCCS/1617/20 opinion
  4. SCCS/1601/18 opinion

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. In the end, it’s only trusted because it’s tested. Discover more on our website and read our brochure.

Next Step

With this regulation amendment, the cosmetic industry should particularly pay attention to the new requirement of Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm. Cosmetic manufacturers are suggested to check the purity of Titanium Dioxide when raw material is purchased for production.

For inquiries, please contact:

Queenie Ho-yan TSE 
Technical Service Manager
t: +852 2765 3672

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