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SCCS -Final Opinion on Sunscreen ingredient, Benzophenone-4
  • 2024-06-03 09:04:53

Diphenylene-4, a sunscreen ingredient is listed in Article 22 of Annex VI to the EU Regulation on Cosmetics (EC) No 1223/2009, with a maximum permissible concentration of 5% (in acids). Its reported use functions are "UV stabilizer" and "UV absorber".

Historical assessment

The SCCNFP (predecessor of SCCS, the Scientific Committee for Cosmetics and Non-Food Products of the European Union) conducted a safety assessment of diphenylene-4 in 1999 and concluded that "diphenylene-4 can be safely used in cosmetic sunscreen formulations up to a concentration of 5% (in acids)". There are no further restrictions on the use in cosmetics.

In early 2019, the European Commission established a priority list of 28 endocrine disrupting substances that have not yet been banned or restricted for safety assessment after collecting data, and benzophenone-4 was one of the substances that solicited data.

During the data collection phase, stakeholders submitted scientific evidence demonstrating the safety of diphenylene-4 as a cosmetic UV filter, and SCCS re-evaluated the safety of diphenylene-4 based on the information provided.

What's New

In 2024, SCCS again issued its assessment of benzophenone-4:

Based on the safety assessment and taking into account concerns related to potential endocrine disrupting properties, SCCS believes that when used as a sunscreen in sunscreens, creams, hand creams, all resident and drenching products (total transdermal exposure), lip balms, sunscreen booster sprays and pump sprays, alone or in combination (based on total exposure), A maximum concentration of 5% is considered safe.

In addition, in other ways of use, such as dibenzophenone -4 under light conditions as a stabilizer in cosmetic formulations, should be kept within the above concentration (i.e. 5%), is also safe.

The above conclusions do not cover the environmental safety of diphenylketon-4.

Regulatory situation in China

According to the regulations on cosmetics in our country, dibenzophenone-4 conforms to the "Technical Specification for the Safety of Cosmetics" quasi-use sunscreen (Table 5) No. 4, which stipulates that the maximum allowable concentration of cosmetics when used is 5% of the total amount (by acid).

As the top leading manufacturer of carbomer and acrylates copolymer, we have cosmetics grade carbomers, including traditional carbomer such as NM-Carbomer 960, carbomer 990, carbomer 941, but also improved carbomer such as NM-Carbomer 20, 2020, 21, 1342, 1382 with INCI Name: Acrylates/C10-30 Alkyl Acrylate Crosspolymer. Also, liquid carbomer such as NM-Carbomer SF-1, with INCI name: acrylates copolymer.

Our pharmaceutical grade carbomer such as carbomer homopolymer, carbomer copolymer and carbomer interpolymer such as NM-Carbomer 934P,974P,971P, 981G, and carbomer 980NF, 940NF, NM-Carbomer 2020G,10G 1382G, etc. All these carbomer as excipients meet the requirements of major pharmacopoeia such as Chinese Pharmacopoeia 2020, USA Pharmacopoeia USP/NF, European Pharmacopoeia EP, British Pharmacopoeia BP, India Pharmacopoeia IP, Japanese Pharmaceutical Excipients JPE and other relevant regulations.

Our professional technical service, R&D team, actively pay attention to the industry development trend and relevant regulations, continue to launch safer raw materials to meet the changing market demand.

Anhui Newman have been approved by ISO9001 quality system, ISO 14001 environmental system and ISO 45001 occupational health and safety system certification in 2015. In January 2023, we successfully passed the assessment conducted by Eco Vadis, a global social responsibility assessment company, actively fulfilled the SA8000 social responsibility standard, reduced pollution emissions, rationally used resources, and ensured that the environment continued to meet the standards. And we constantly improved the construction of the company's social responsibility management system, and effectively fulfilled social responsibilities. Strengthening communication and exchanges with partners and other stakeholders, to promote the company to better fulfill social responsibilities and support social public welfare undertakings, and realize the harmonious development of itself, society, and environment.

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