Pre-Show Regulatory Conference

Pre-Show Regulatory Conference

05 October 2020, 13:30 - 18:30

Workshop Room 1
Language:
English

Co-organised by STANPA

Regulatory and compliance professionals can strengthen and advance their understanding of worldwide cosmetic regulations and legislation with the in-cosmetics Global Pre-Show Regulatory Conference. Open to both cosmetic manufacturers and suppliers of cosmetic ingredients, the conference offers expert insights and solutions into staying complaint within differing international personal care frameworks.

Attendees can expect an in-depth evaluation of the world's biggest markets and their key regulatory modules, with a particular focus on the EU, Latin America, the Middle East, Asia Pacific and North America, which will help them streamline the development and launch of their new personal care products.

Topics included:

  • European Union - microplastics, endocrine disruptors
  • Latin America - ANDEAN and Pacific Alliance
  • Middle East - Regulatory update for cosmetics exports to Saudi Arabia and GSO standards
  • Asia Pacific - Implementation of CSAR in China, South Korea to amend enforcement rule of cosmetics act, overview of cosmetics regulations in India, updates of regulations on Halal certification
  • North America - Sunscreen drug products for over-the-counter humane use

Details of the conference:

Prospective of microplastics in cosmetics
María Álvarez López, Technical Advisor, Stanpa

The European Commission has launched a global strategy on plastics to protect the planet, defend our citizens and empower our industries as part of the transition to a more circular economy. We will talk about one of the main measures contained in the strategy: Restriction on the use of microplastics: The Commission wants to restrict the manufacture of products with microplastics, the most difficult to control, which contaminate the entire food chain, even our own bodies, according to more and more scientific evidence. In addition, we will summarize the content of the proposed restriction, implications for the cosmetic sector, key dates, actions carried out by Stanpa and next steps.

Endocrine disruptors in cosmetics - Towards coherent and science-based EU-wide approach
Pilar García Hermosa, Technical Director, Stanpa

The Commission adopted the review of Regulation (EC) No 1223/2009 on cosmetic products containing endocrine-disrupting substances in 2018. The report takes stock of how substances considered as potential endocrine disruptors were tackled under the cosmetics regulation. The conclusion is that the cosmetics regulation provides adequate tools to regulate cosmetic substances that potentially risk human health. The Commission also committed to creating a priority list of potential endocrine disruptors that were not covered by the regulation bans yet. Thus, the Commission consolidated a list of 28 substances that will be later on evaluated by the SCCS. Then, the Commission will take action to prohibit or restrict the use of these substances in cosmetics if needed. We will summarize the process and the current situation.

Pacific Alliance: the new bet on industry growth in the region
Juan Carlos Castro, General Director / Vice-President, ANDI / CASIC

The cosmetic industry was the first to be considered and approved by the Pacific Alliance Governments, to have a TECHNICAL BARRIERS TO TRADE ANNEX, including Best International Practices:

  • Adoption of a harmonized definition for cosmetics (based on the European definition)
  • Establishment of an in market-surveillance system
  • Elimination of any pre-market approvals for cosmetics or replacement for an automatic notification scheme
  • Elimination of the requirement of Free Sale Certificate for commercialization
  • Recognition of international cosmetic ingredients lists, based on the European and United States listings
  • Harmonization of labeling requirements based on international standards, avoiding any requirement for sanitary number’s
  • Harmonization of GMP’s requirements, based on international standards (verifiable by means of the in market-surveillance system)


New Andean Decision 833, a more global legislation for the promotion of trade in the Andean region
Juan Carlos Castro, General Director / Vice-President, ANDI / CASIC

The main task taken during the update of the Andean decision was to bring the best international practices to the norm as well as making the regulation compatible for other Free trade agreements such as Pacific alliance and Mercosur.

  • Adoption of a harmonized definition for cosmetics
  • Elimination of any pre-market approvals for cosmetics
  • Establishment of an in market-surveillance system
  • Elimination of the requirement of Free Sale Certificates for commercialization
  • Development of compatible labeling regulations with international/regional standards avoiding any requirement for sanitary numbers (registration, process, notification or other)
  • Harmonization of filling tolerances (particularly for soap bars)
  • Elimination of the requirement to test each batch of imported products
  • Recognizing GMP’s compliance when international standards are enforced in the country of origin (verifiable by means of the market-surveillance system, not through a certification)
  • Recognition of international cosmetic ingredients lists

 

Cosmetic regulation in China, latest updates and preparation for the coming changes
Marie Magnan, Regulatory Affairs Manager, COSMED

In 2019, some regulations and projects have been published by the National Medical Product Administration, in charge of cosmetics in China. The new regulation CSAR (Cosmetic Supervision and Administration Regulation) long awaited, can be expected for publication in 2020. The issues for companies exporting to China are therefore to understand and anticipate the consequences of these regulatory changes. 

  • Latest updates and main draft projects published in 2019: Changes in testing requirements and other updates, Measures for filling non-special use cosmetics, Inspection of overseas manufacturers.
  • CSAR, anticipate the coming changes: what to expect, equality of treatment with domestic manufacturers, preparing for compliance and next steps



ASEAN, India and Korea regulatory updates
Alain Khaiat, PhD, President, Seers Consulting

The presentation will focus on the variations in interpretation and implementation of the ASEAN Cosmetic Directive in the different ASEAN Member States. 

Indonesia Halal law has been published and is implemented. What are the steps companies have to be prepared for? When the full implementation is going to be mandatory? We will review the status.

We will review the recent updates to the regulations in India and Korea.

Regulatory update for cosmetics exports to Saudi Arabia and GSO standards
Houda Hediouech, Regulatory Affairs Expert, Intertek

To place cosmetic products on the Saudi market, the regulatory requirements of the GCC and KSA must be met (ingredients, packaging, safety etc). A Conformity Assessment Program (CAP) has been implemented to ensure the conformity and safety of the products. That means, a Certificate of Conformity (CoC) is required to clear products through Saudi Customs.

Current status of the U.S. FDA tentative final monograph for sunscreen products – an industry perspective
Tom Myers, Executive Vice President-Legal & General Counsel, PCPC

Forty-two years after the original final sunscreen monograph published, the U.S. FDA has now issued a comprehensive new rulemaking that would amend virtually every aspect of the monograph and fundamentally change how sunscreens are formulated, tested and marketed in the United States. Perhaps most importantly, FDA is requesting additional data regarding the safety of individual sunscreen active ingredients in light of changing conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since they were first evaluated.

This presentation will offer an insider’s perspective on how industry is currently responding to this comprehensive new proposal and what companies, and consumers, can expect. 

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Contributors

  • Pilar García Hermosa

    Speaker

    Technical Director

    Stanpa - Asociación Nacional de Perfumería y Cosmética

    Pilar García Hermosa is the Scientific Technical Director at Stanpa, the Spanish Perfumery and Cosmetics Association. She holds a PhD in Biophysics...

  • María Álvarez López

    Speaker

    Technical Advisor

    Stanpa - Asociación Nacional de Perfumería y Cosmética

    María Álvarez has a degree in Pharmacy from the University of Complutense of Madrid, and she is specialiced in Pharmaceutical and Parapharmaceutical...

  • Juan Carlos Castro

    Speaker

    General Director / Vice-President

    ANDI / CASIC

    Juan Carlos Castro is a professional in Finance, Government and International Relations, with specialization in Marketing Management with more than...

  • Marie Magnan

    Speaker

    Regulatory Affairs Manager

    COSMED

    Marie MAGNAN is regulatory affairs manager at COSMED, the French Professional Association for SMEs in the cosmetic field. She is specialized in...

  • Alain Khaiat, PhD

    Speaker

    President

    Seers Consulting

    Dr. Khaiat was awarded the first in-cosmetics Lifetime Achievement Award in Paris in April 2010. With 40 years of experience in the cosmetic industry...

  • Houda Hediouech

    Speaker

    Regulatory Affairs Expert

    Intertek

    Houda HEDIOUECH, cosmetic regulatory affairs expert at INTERTEK France since 2013. As a senior consultant, she is in charge of assessing the...

  • Tom Myers

    Speaker

    Executive Vice President-Legal & General Counsel

    Personal Care Products Council (PCPC)

    Thomas F. Myers (Tom) is the Executive Vice President-Legal & General Counsel for the Personal Care Products Council (PCPC) and is responsible for...

Sponsors

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