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30/11/2016

Access and Benefit Sharing: European Commission Guidance for the Cosmetics Sector and Cosmetics Industry Best Practice

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Contents

1. The European cosmetics industry: some facts and figures

2. Work on ABS in the cosmetics industry: cooperation along the value chain

3. Upcoming EC guidelines for the cosmetics sector: insights from the drafting process

4. Best Practice: the content and the process

5. Next steps

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1. Cosmetics Europe: some facts and figures 1. The European cosmetics industry: some facts & figures

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2. Work on ABS: cooperation along the value chain

• EFfCI (suppliers of cosmetic ingredients)

• IFRA (suppliers of fragrance materials)

• UNITIS (suppliers of natural cosmetic ingredients)

• Cosmetics Europe (manufacturers of finished cosmetic products)

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Cosmetic products cover a wide range: - Skin care - Hair care - Oral care - Decorative cosmetics - Toiletries - Fragrances

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Cooperation between Cosmetics Europe, EFfCI, IFRA and UNITIS:

• Working together on ABS matters since 2014

• Developed an Explanatory Document on the EU ABS Regulation for use by their respective members

• Organised (sometimes jointly) ‘train the trainers’ seminars for their national associations

• Developed Best Practice for the cosmetics sector which was submitted to the European Commission in February 2016

• Are contributing to the drafting of the European Commission guidelines for the cosmetics sector

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3. Upcoming EC guidance for the cosmetics sector

• Document drafted by a stakeholder group (EC’s consultant Arcadia, UEBT and industry representatives)

• Latest draft takes into account the outcome of the EC workshop (19.09.2016) and is following the model of the pharmaceutical sector

The industry is elaborating on several aspects:

• sector activities and the R&D process

• types of genetic resources and derivatives

• specific activities under analysis (> 30 examples)

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Derivative: naturally-occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity; examples: honey, essential oils, flavonoids, resins from plants, algae extract, sphingolipids, etc.

Typical development process:

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Specific types of activities under analysis:

• Development of a novel cosmetic ingredient where either the ingredient itself or one of its components originates from a genetic resource (18 examples)

• Use of a genetic resource in activities which are not part of the R&D on the genetic and/or biochemical composition of genetic resources in the meaning of the EU ABS Regulation (8 examples)

• Use of a genetic resource as a (research) tool during the development process of a cosmetic product, but not part of the product itself (3 examples)

• Use of a genetic resource in R&D activities to help identify a product, but not part of the product itself (1 example)

• Use of a genetic resource originating from a party to the Nagoya Protocol in a country which is not party to the Nagoya Protocol, to develop a product which is transferred to the EU for further modification (1 example).

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4. Best Practice: the content and the process

Article 8 of the EU ABS Regulation (511/2014): “combination of procedures, tools or mechanisms, developed and overseen by them”, supported by “evidence and information”. Annex IV of the Implementing Regulation (2015/1866): “information to be provided with an application for recognition of best practice pursuant to Article 8(1)”.

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Contents of the Best Practice:

• Mainly based on the text of the EU ABS Regulation, with elements from the Nagoya Protocol

• Flowchart illustrating the due diligence compliance process

• Example of a template stating a supplier’s compliance with due diligence

• Examples of templates, terms and elements typically included in MATs

• Examples of monetary and non-monetary benefits

• Measures to protect interests and rights of indigenous communities

• Ways in which the four associations plan to oversee the Best Practice

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Development process:

• Drafting by Cosmetics Europe, EFfCI, IFRA and UNITIS: throughout 2015

• Joint submission to the European Commission: February 2016

• Feedback from the European Commission: July 2016

• On form: application complete but some points require further clarification (mainly the process of overseeing the Best Practice)

• On substance: alignment needed with the EC ‘Horizontal Guidance’ (published in August 2016), further guidance on seeking and keeping information, traceability, confidentiality, MATs and benefit-sharing, more specificity to the cosmetics sector, etc.

• The four associations will address the Commission’s comments and will produce a revised Best Practice once the Commission’s guidance for the cosmetics sector is finalised.

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5. Next steps

• Finalise contribution to the EC guidelines for the cosmetics sector (January 2017) [the EC will consult Member States, finalise the document and decide how and when to make it available]

• Address EC comments on the Best Practice and re-submit application

for recognition (Q4 2017) • Organise second wave of training seminars for membership (Q4 2017) • Promote Best Practice and collect feedback on its implementation by

member companies (2018) • Work with national associations in countries which issue legislation /

rules for access and benefit-sharing (ongoing) • Liaise with cosmetics associations beyond the EU (ongoing)