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[Chemlinked] How Are Endocrine Disruptors Regulated by EU Cosmetics Regulation?

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등록일 2022-06-24

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Endocrine disruptors are chemical substances that alter the functioning of the endocrine system and negatively affect the health of humans and animals. Under EU Cosmetics Regulation, suspected endocrine disruptors will be banned or restricted on a case-by-case basis following their safety assessment result by Scientific Committee on Consumer Safety (SCCS). In early 2019, a priority list of 28 potential endocrine disruptors in cosmetics was compiled, among which the SCCS released opinions for 12 so far.

 

Endocrine disruptors (EDs), which may either be of synthetic or natural origin, are chemical substances that alter the functioning of the endocrine system, and consequently produce adverse effects upon the health of humans and animals. Compared to other toxicological chemicals, the property of EDs make us also pay attention to the mechanism how they interfere with the functioning of the hormonal system, in addition to the toxic effect they bring about. Various sources may cause exposures to EDs, one of which is the consumer products used or exist in our daily life, including cosmetics.

This article introduces the supervision requirements for EDs within the EU, especially under the regulation on cosmetics, and presents SCCS's assessment opinions on substances suspected to be EDs.

 

Regulatory Requirements for EDs at EU Level

The EU has been at the forefront of supervision for EDs. Since the release of "Community Strategy for Endocrine Disrupters" in December 1999, its response to EDs has well developed over the past 20 years. Currently, EU's action on EDs relies largely on the work undertaken by the EU scientific assessment bodies, such as Scientific Committee on Consumer Safety (SCCS), Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), and the European Chemicals Agency (ECHA). Following the hazard or risk assessments conducted by these bodies, the EU Commission then takes the final decision on risk management measures as appropriate. 1

Within the EU, different regulatory approaches are stipulated in different pieces of legislation for substances that have endocrine disrupting properties:

  • In the regulations on pesticides and biocides, chemicals in general, and medical devices, specific provisions are detailed to address EDs. By way of example, under the REACH Regulation, short for Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, EDs are specifically mentioned as substances that can be identified as Substances of Very High Concern (SVHCs) and can therefore be subject to authorization and restrictions requirements.
  • For other pieces of legislation, such as the regulations on cosmetics or food contact materials, though they do not mention EDs specifically, there are general provisions for the risk management of hazardous substances which can be used to control the risks posed by EDs.

Though the regulatory approaches differ, all legislative instruments of different areas within the EU support effective actions on EDs to avoid risks for human health and the environment.

 

Management of EDs under the Cosmetics Regulation

Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetics Regulation) provides a regulatory framework to protect consumers from exposure to hazardous chemicals in cosmetic products. To address potential risks for human health, the Cosmetics Regulation lays down a system of restrictions and bans on the use of certain substances in cosmetics based on scientific risk assessment carried out by the SCCS.

In terms of the management of EDs, the Cosmetics Regulation does not have any specific provisions. However, like other substances of concern for human health, substances identified as EDs are currently subject to the general safety assessment of the SCCS. To be specific, for a substance identified or considered as a potential ED,

  • If this substance has also been classified as a CMR (a substance classified as carcinogenic, mutagenic or toxic for the reproduction), then the substance shall be banned unless a derogation to the ban is granted subject to the strict requirements in Articles 15(1) and 15(2) of the Cosmetics Regulation;
  • If this substance is not classified as a CMR, its use in cosmetics should follow the general provisions in Article 31 of the Cosmetics Regulation, which requires a scientific opinion of the SCCS.

Upon the receipt of SCCS's safety assessment, the Commission will then implement appropriate measures to restrict or ban the use of the suspected ED substance in cosmetic products.

 

SCCS's Opinions on 28 Substances Suspected to be EDs

On November 7, 2018, the Commission adopted a review of the Cosmetics Regulation regarding substances with endocrine disrupting properties, which concluded that the Cosmetics Regulation provided adequate tools to regulate the use of cosmetic substances that presented a potential risk for human health. In the review, the Commission also committed to establishing a priority list of potential EDs not already covered by the bans or restrictions in the Cosmetics Regulation for their subsequent safety assessment. 2 Based on the input provided through a stakeholder consultation, a priority list of 28 potential EDs in cosmetics was consolidated in early 2019.

To prioritize the substances on this list, internal discussions were carried out to confirm if any of these 28 substances were being assessed under REACH for ED concerns. Additionally, an informal consultation with the SCCS helped prioritize the substances based on scientific evidence/literature. As a result of these discussions, the list of 28 substances was split into the 2 following groups:

 

1. Group A: 14 Substances with Higher Priority for Assessment

At the time of publication of the priority list, the 14 Group A substances were undergoing substance evaluation (SEV) under REACH for ED concerns or the SEV had already confirmed ED concerns. Up to now, the SCCS has released opinions for 12 Group A substances.

No.

INCI Name

CAS No.

SCCS’s Opinion

1

Benzophenone-3

131-57-7

SCCS/1625/20

2

Propylparaben

94-13-3

SCCS/1623/20

3

Resorcinol

108-46-3

SCCS/1619/20

4

Octocrylene

6197-30-4

SCCS/1627/21

5

Homosalate

118-56-9

SCCS/1622/20

SCCS/1638/21

6

Kojic Acid

501-30-4

SCCS/1637/21

7

4-Methylbenzylidene Camphor (4-MBC)

36861-47-9

SCCS/1640/21

8

Triclosan

3380-34-5

SCCS/1643/22

(Preliminary)

9

Triclocarban

101-20-2

SCCS/1643/22

(Preliminary)

10

BHT / Butylated hydroxytoluene

128-37-0

SCCS/1636/21

11

Benzophenone

119-61-9

Classified as a CMR

12

Benzyl salicylate

118-58-1

Under review

13

Genistein

446-72-0

SCCS/1641/22

(Preliminary)

14

Daidzein

486-66-8

SCCS/1641/22

(Preliminary)

 

2. Group B14 Substances with Low Priority for Assessment

At the time of publication of the priority list, for the 14 Group B substances, no SEV had been initiated or the outcome of the SEV was of environmental ED concern instead of human health concern. Since February 15, 2021, the Commission has been collecting data related to the first 10 substances listed below through the second public call for data. Upon receipt of sufficient data, the Commission will mandate the SCCS to evaluate the substances as soon as possible.

No.

INCI Name

CAS No.

1

Butylparaben

94-26-8

2

Methylparaben

99-76-3

3

Ethylhexyl Methoxycinnamate (EHMC) / Octylmethoxycinnamate (OMC) / Octinoxate

5466-77-3 / 83834-59-7

4

Benzophenone-1 (BP-1)

131-56-6

5

Benzophenone-2 (BP-2)

131-55-5

6

Benzophenone-4 (BP-4)

4065-45-6

7

Benzophenone-5 (BP-5)

6628-37-1

8

BHA / Butylated Hydroxyanisole / Tert-butylhydroxyanisole

25013-16-5

9

Triphenyl phosphate

115-86-6

10

Salicylic Acid

69-72-7

11

Cyclopentasiloxane / Decamethylcyclopentasiloxane / D5

541-02-6

12

Cyclomethicone

69430-24-6 / 556-67-2 / 541-02-6 / 540-97-6

13

Butylphenyl Methylpropional / BMHCA

80-54-6

14

Deltamethrin

52918-63-5

As regards substances Cyclopentasiloxane / Decamethylcyclopentasiloxane / D5, Cyclomethicone, Butylphenyl Methylpropianol / BMHCA and Deltamethrin, they were excluded in this call for data due to other pending regulatory measures or discussions that could prejudge the need for further action.

 

Further Reading

 

Reference Links

[1] Commission Staff Working Document Fitness Check on Endocrine Disruptors

[2] Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products with Regard to Substances with Endocrine-disrupting Properties

 

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