Testing & Regulation Zone | in-cosmetics Connect

Two policy shifts towards animal testing in China’s cosmetic sector

in-cosmetics Group — Tue, 29 Sep 2020 09:11:35 +0000

China has started its cosmetic regulatory reform since the finalization of the overarching regulation- Cosmetic Supervision and Administration Regulation (CSAR) on June 29, 2020, and is releasing a series of subsidiary regulations to improve its new cosmetic regulation framework.

Starting from the initiation of the cosmetic regulatory reform, whether China will soften its stance on animal testing under the new cosmetic regulatory framework has been the most concerned topic in the industry. Encouragingly, two draft subsidiary regulations of CSAR released on August 28 (Instructions for Cosmetic Registration and Notification Dossiers and Instructions for New Cosmetic Ingredient Registration and Notification Dossiers) introduce 2 policy shifts towards animal testing management in China.

Policy shift 1: Imported general cosmetics can be exempted from animal testing

According to the draft Instructions for Cosmetic Registration and Notification Dossiers, companies can apply for exemption of animal testing for imported general cosmetics if they fulfill the following conditions:

The manufacturers have obtained the relevant certification of GMP issued by the cosmetic regulatory authority of the country (region) where they are located.
The safety assessment results can fully confirm the safety of products.

General cosmetics refers to all the products complying with the definition of cosmetics within the CSAR, except for the special cosmetics namely hair dyes, hair perming products, freckle-removing and whitening products, sunscreens, anti-hair loss products and cosmetics claiming new efficacy.

However, the Instructions also regulate that in the following cases animal testing will be required:

Products claim to be used by children
Products using new cosmetic ingredient during their 3 years of required monitoring
The notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA
The notifier/RP/manufacturer has been investigated and penalized due to quality or safety issues

As long as one of these conditions apply, companies are still required to conduct animal testing.

ChemLinked Comments:

Some overseas cosmetic companies may face a barrier for the animal testing exemptions as they may fail to submit the GMP certificate granted by the local government cosmetic authority. In some regions, like the EU, the government cosmetic authority won’t issue an official GMP certificate due to the local cosmetic regulatory scheme. The GMP certificates that can be provided are generally issued by cosmetic associations or international standardization organizations.

Policy shift 2: International alternatives can be accepted for new cosmetic ingredients

Instructions for New Cosmetic Ingredient Registration and Notification Dossiers regulates that international alternatives recognized by an international authoritative alternative validation agency such as OECD, ICCR, ICCVAM, EURL-ECVAM, JaCVAM, etc. can be accepted for the notification or registration of new cosmetic ingredients.

To use the data derived from International alternatives, companies shall comply with 2 requirements:

The appropriate Integrated Approaches to Testing and Assessment (IATA) shall be selected to evaluate the toxicity based on the characteristics of the new ingredient and the specific toxicological endpoint.
Supporting documents proving the consistency of results obtained from the alternatives and the existing toxicological testing methods in China shall be submitted.

For the supporting documents, they can be related research papers and scientific works that have been openly published and include detailed analysis, or testing reports issued by an internationally accepted Good Laboratory Practice (GLP) compliant labs. They shall include a brief description of the testing method research process, comparative research data of not less than 10 test substances, result analysis, conclusions and original texts, etc.

ChemLinked Comments:

Similar to the animal testing exemption for imported general cosmetics, the conditions for the acceptance of international alternatives are also stringent. It is quite difficult for companies to provide such supporting documents as the existing qualified research papers and scientific works are rare and the fees for conducting the required testing and obtaining the testing reports are very expensive.

Although there are great limitations, these 2 new policies are undeniably a big step taken by China towards reducing animal testing. Animal testing ban is undoubtedly a future trend so we can expect China to gradually start phasing out animal testing.

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Natural & Organic roundtable: Overcoming industry challenges

Amarjit Sahota, President, Organic Monitor — Wed, 20 Jul 2016 13:17:08 +0000

The roundtable of in-cosmetics Asia in 2015 looked at the major challenges faced by operations in the natural and organic cosmetics industry.

The roundtable will discuss some of the major challenges faced by operations in the natural and organic cosmetics industry. The role of certification/standards will be discussed, as well as related issues like raw materials, greenwashing, and marketing. How important are standards? What raw material issues do brands face in Asia? What are the marketing and distribution issues?

Come back to this news page weekly to see a new Marketing Trends & Regulations presentation that was taken at the show: news.in-cosmetics.com

Video taken at in-cosmetics Asia – The leading exhibition and conference in Asia for personal care ingredients – takes place in Bangkok in November – more info at www.in-cosmeticsasia.com

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Latest regulation changes in Asia – how best to adapt

Alain Khaiat, PhD, Owner, Seers Consulting — Wed, 20 Jul 2016 12:52:50 +0000

At in-cosmetics Asia in 2015, Alain Khaiat, Owner of Seers Consulting, looked at latest regulation changes in Asia– how best to adapt.

Asian countries are prolific in new regulatory requirements that directly or indirectly affect the cosmetic products. This video will go through the latest development and how to adapt to an ever changing environment.

Come back to this news page weekly to see a new Marketing Trends & Regulations presentation that was taken at the show: news.in-cosmetics.com

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Animal testing: Requirements and pitfalls

Alain Khaiat, PhD, Owner, Seers Consulting — Wed, 20 Jul 2016 12:31:53 +0000

At in-cosmetics Asia in 2015, Alain Khaiat, Owner of Seers Consulting , looked at Animal testing: Requirements and pitfalls.

Following the EU ban on animal testing for cosmetic products and now for cosmetic ingredients, what are the requirements around the World and how to comply?

The seminar will go over the regulatory requirements but also will look at the science behind the need for alternative methods

Come back to this news page weekly to see a new Marketing Trends & Regulations presentation that was taken at the show: news.in-cosmetics.com

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How Dermal Absorption Testing can be used effectively in the Risk Assessment for Cosmetic Products and Ingredients

Thu, 05 Mar 2015 08:00:57 +0000

In order to ensure the safety of cosmetic products, it is important to determine how much of the active ingredient can be absorbed into and through the skin. These values are used in a risk assessment together with other toxicological information gained from regulatory studies that have characterised the hazard potential of the active. When this information is assembled in a regulatory dossier, a margin of safety is used to ensure that the amount of the active that could reach the systemic circulation is much lower than the amount known to cause an adverse effect in an animal study, or an equivalent regulatory-approved predictive in vitro study. These so-called “safety factors” are conventionally arbitrary values (often 10 or 100) that are used to provide a significant separation between the quantities of the cosmetic ingredient in question known to cause an adverse effect and the actual quantities that reach the systemic circulation via the dermal route. We accept that these safety factors must be conservative due to potential differences in response between species and to ensure that susceptible individuals are sufficiently protected. We all wish to minimise the extent to which animals are used to define toxicological end points, and clearly, if an in silico or in vitro approach is deemed fit-for-purpose, we would all advocate using alternative approaches for the safety testing of cosmetics.

The development of the in vitro test guideline OECD 428 for dermal absorption testing makes an interesting story, since this is one area of safety assessment where the in vitro approach has been shown to be more predictive of human systemic exposure than animal studies. Donated human skin is now used extensively by industry for dermal absorption studies, and is recognised by the WHO/IPCS as the “gold standard” for human risk assessment in this area. The SCCS have specific guidance for in vitro dermal absorption testing that encompasses the myriad of exposure scenarios for products as diverse as hair dyes, sunscreens and leave-on cosmetics. This in vitro approach will be described, including key aspects of the method that define the absorbed/penetrated dose and the unabsorbed skin-bound dose, including how this is influenced by physicochemistry and specific formulation components. A new approach will be presented for the screening and development of new cosmetic ingredients and formulations and how dermal absorption is best placed in the overall sequence of safety testing in order to improve the development, safety and registration of new cosmetic products.

Professor Jon Heylings is speaking at the Novel strategies towards regulatory compliance after Regulation (EC) 1223/2009 was set in motion workshop at in-cosmetics on Tuesday 14 April 2015, 09:00 – 13:00 Workshop Room CC5.3

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Non-Animal based Safety Assessment Methodologies in support of R&D and final Product Placement

Dr. Thomas Petry, Managing Director, ToxMinds BVBA — Thu, 26 Feb 2015 14:00:28 +0000

Traditionally, the toxicological hazards of chemical substances have been identified and assessed on the basis of experimental studies in animals and, to some extent, from reports following human use. Fuelled by a combination of societal expectations, political pressure and economic considerations, there is now an increased demand for reducing animal testing in chemical safety assessment. Regulatory-wise, this demand already manifested itself in the complete animal testing ban, as stipulated in the new EU Cosmetics Regulation or the promotion of the 3R (Reduce, Refine, Replace) concept in the EU Chemicals Regulation REACH. In response, an enormous amount of public or industry funding has been invested and collaborations have been established world-wide to address the chemical safety assessment needs without or with limited use of experimental animals.

We have to be realistic – there won’t be a single ‘alternative method’ providing all the information required to assure the safety of a chemical. Non-animal based safety assessment of chemicals in the 21st century will utilize the increasing power of computational chemistry in combination with advanced systems biology, high through-put in vitro screening and ‘omic’ technologies to predict the toxic potential and prioritize chemicals with respect to the need for further toxicological evaluation. Computational toxicology approaches such as grouping, read-across, (Q)SAR ((quantitative) structure-activity relationships), thresholds of toxicological concern (TTC), physiologically-based pharmacokinetic modelling and in vitro to in vivo extrapolation are being used, further developed and, in some cases, in the process of being validated.

While it must be recognized that current non-animal approaches are not yet suitable to fully replace animal testing for all newly developed chemicals, existing predictive non-animal based tools already offer substantial opportunities for businesses to understand the toxicity of new chemicals in development, thereby decreasing business uncertainties. These tools allow for example the prioritarisation of candidate chemicals within a group of ‘lead actives’ for further R&D qualification and investment at low cost within a short period of time (compared to traditional toxicology testing). Moreover, these tools support business decisions by early identification of remaining data gaps and costs related to further toxicology testing required across entire chemical portfolio (e.g., in context of REACH phase III registrations).

In my presentation ‘Non-animal based safety assessment methodologies in support of R&D and final product placement’ presentation at the In-Cosmetics 2015 Regulatory Workshop, I will provide an overview of predictive approaches and how they can be used in the various steps of product development, and , in safety support of products to be placed on the market. While the focus will be on presenting a transparent and reproducible SAR/analogue-based hazard assessment approach, an overview will also be provided on how remaining data gaps or uncertainties can be supplemented with additional non-animal based testing.

Dr. Thomas Petry is speaking at the Novel strategies towards regulatory compliance after Regulation (EC) 1223/2009 was set in motion workshop at in-cosmetics on Tuesday 14 April 2015, 09:00 – 13:00 Workshop Room CC5.3

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in-cosmetics 2014: Testing & Regulation Zone

in-cosmetics Group — Thu, 03 Apr 2014 12:22:26 +0000

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