Cosmetic Products Regulations in Israel and the European Union

 a Comparative Overview

Date: 16, 17 February 2016
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 09:00-17:00
Price: 3,500 NIS + VAT
Credit Points: 2
SKU: 16686
Course Language: English
About the Course
Regulation (EC) No 1223/2009 on cosmetic products is fully implemented since July 2013 and represents a modern regulatory framework grounded on state of the art of science and product development. It is structured in regulatory modules, e.g. safety assessment, responsible person (RP), labeling, cosmetovigilance, etc., and as such it represents a role model for many other national cosmetics legislations worldwide, where either the Regulation’s or its predecessor framework, the Cosmetics Directive’s, provisions were fully adopted or in certain of the modules. This applies as well to the new Pharmacists’ Regulations (Cosmetics) 2012-5773 of Israel. The workshop focuses on the EU’s regulatory modules, depicts the specific provisions and how to approach compliance with these. An Introduction into both regulatory frameworks will in a first approach lead to an analysis of similarities and differences. With these results, the workshop will focus on regulatory modules with similarities and present the legal provisions for each module as well as practical examples and experiences made in performing the required compliance steps for marketing cosmetics in the European Union under Regulation 1223/2009. Modules and borderline areas addressed in-depth include the following:
  • The Animal Testing Ban
  • Safety Assessment, PIF
  • Responsible Person
  • Criteria for Claims
  • Cosmetovigilance
  • Substances’ Regulation
  • Labeling
  • Interfaces with other EU Legislation (REACH, Borderline Products)
Who should attend
Members of:
  • Cosmetics, personal care and consumer health product industries
  • Ingredient suppliers, fine chemicals companies
  • Regulatory affairs
  • R&D, product formulation
  • Marketing, product management
  • International sales, export
  • Government officials, KOLs
Cosmetic Products Regulations in Israel and the European Union
Benefits to the Participants
The workshop introduces the EU’s regulatory modules and relates these to the new Israeli law. The specific provisions for each module will be depicted and ways of proceeding towards meeting compliance will be demonstrated to the participants. A key value will be laying in joining in practical experiences made, especially during the implementation phases of the Regulation between 2009 and 2013, and as such gaining stimulation and guidance on how to address the new Israeli law.
Contact us
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Issues to be covered
DAY 1

Welcome & Introduction
09.00 – 09.45 Part 1: The Pharmacists’ Regulations (Cosmetics) 2011-5772
  • Draft proposal by Binyamin Netanyahu, Prime Minister and Health Minister, Israel 2011 – An Overview
Rinat Bachar
Israeli Ministry of Health (MOH),
Cosmetics Department
09.45 – 10.30 Part 2: Amending Existing Legislation: Regulation (EC) 1223/2009
  • Cosmetics Product Regulation
  • The Recast and its Legislative Environment
  • Main Drivers for the Amendment
  • Key Outcome - Areas of new contents & provisions
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
10.30 – 10.45 Q&A / Discussion
10.45 – 11.00 Coffee Break
11.00 – 12.00

Part 3: Analysis on Similarities and Differences for the two Regulatory Frameworks

  • [Notice of Importation, Definition: Manager (granting according to Regulation 8), Recognized Country, General Cosmetics License, Suitable Cosmetics’ Storage and Transport Conditions, Certificate of Free Sale in the country from which it is being imported, Microbial Quality, Notification, etc.]
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
12.00 – 12.30

Part 4: Key Chapters of the EU Cosmetics Product Regulation – The Animal Testing Ban

  • Key drivers for the animal testing ban
  • Stages of implementation in Europe
  • Existing legal situation in Europe – worldwide comparison
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
12.30 – 13.30 Lunch Break
13.30 – 14.00

Part 5: Key Chapters of the EU Cosmetics Product Regulation – The Animal Testing Ban

  • Progress in development of alternative non-animal methods
  • Challenges arising for the industry from the testing & marketing bans
  • The future toolbox for toxicologists
  • Issues and opportunities for developing new cosmetic ingredients
  • Conflicts with other European legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
14.00 – 14.30

Part 6: Key Chapters of the EU Cosmetics Product Regulation - Roles & Responsibilities in the Supply Chain

  • The Actors in the Supply Chain - Definitions
  • Allocation of Responsibility for Product Safety
  • The Responsible Person - Obligations of the Responsible Person
  • Specific Distributor Obligations
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
14.30 – 15.00

Part 7: Key Chapters of the EU Cosmetics Product Regulation - Product Information File (PIF)

  • Content, format, language
  • Interaction with competent authorities
  • Maintenance
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
15.00 – 15.15 Q&A / Discussion
15.15 – 15.30 Coffee Break
15.30 – 17.00

Part 8: Key Chapters of the EU Cosmetics Product Regulation - Safety Assessment

  • Requirements for the Product Safety Assessment
    • PART A – Cosmetic product safety information
    • PART B – Cosmetic product safety assessment
  • How to approach a safety assessment
    • The SCCP’s notes for Guidance & Commission Guidance to Annex I
    • Intrinsic information requirements for cosmetic ingredients
    • Toxicological profile for ingredients & cosmetic products, sources & data evaluation
    • Criteria for trace contents, microbiology, exposure
    • Information going into the weight-of-evidence approach - data generated from other regulatory processes
Dr. Annelie Struessmann
Technical Director
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
DAY 2
09.00 – 09.30 Part 1: Review and Q & A on Day 1
09.30 – 10.00

Part 2: The European Union

  • The Political Union
  • The European Union In the World
  • The Cosmetics Market and the Industry
Steven L. Hanft
M.A., President
CONUSBAT
Aachen, Germany
10.00- 10.30

Part 3: The European Union’s Legal Authority and Approach to Industry Regulation

  • Basic Principles
  • Legal Tools
  • The legal process for the example of the Cosmetics Product Regulation
  • EU modules in world-wide regulations
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
10.30 – 11.00 Coffee Break & Discussions
11.00 – 11.45

Part 4: Key Chapters of the EU Cosmetics Product Regulation - Criteria for Claims

  • Article 40: Claims & process towards determining claim criteria
  • Regulation (EU) No 655/2013 on criteria for claims
  • Claims criteria – horizontal legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
11.45 – 12.30

Part 5: Key Chapters of the EU Cosmetics Product Regulation - Cosmetovigilence

  • Serious undesirable events – definition & reporting
  • PIF Documentation
  • Access to information for the public

Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany

12.30 – 13.30 Lunch Break
13.30 – 14.15

Part 6: Key Chapters of the EU Cosmetics Product Regulation - Substance Regulations

  • Cosmetics Annexes – Inclusion processes
  • Nanomaterials
  • CMRs
  • Hair Colorants

Part 7: Key Chapters of the EU Cosmetics Product Regulation – Product Labelling

  • Requirements from the Cosmetic Product legislation
  • Other applicable EU legislation
Dr. Annelie Struessmann
Technical Director
CONUSBAT

Aachen, Germany
15.00 – 15.15

Q&A / Discussion

15.15 – 15.30 Coffee Break
15.30 – 16.00

Part 8: Interfaces between the Cosmetics Product Regulation and EU legislation for chemicals - REACH

  • Requirements for cosmetic ingredients
  • Challenges from testing requirements
  • Classification and labeling of hazardous substances and mixtures
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
16.00 – 16.30

Part 9: Borderline Legislation

  • Medicinal Products
  • Biocides
  • General Product Safety
  • Worldwide Outlook
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
16.30 – 17.00

Part 10: Implementing regulatory affairs to the stages of product development

  • Pre- and post-marketing compliance processes
  • Regulatory environment applicable to cosmetics
  • Compliance specifics and potential pitfalls for non-EU manufacturers
  • Products and ingredients with need for special awareness
  • Supporting tools
Dr. Annelie Struessmann
Technical Director
CONUSBAT
Aachen, Germany
  Farewell Tali Rahinstein
Bioforum
About The Lecturer

Dr. Annelie Struessmann

Technical Director, CONUSBAT
Dr. Annelie Struessmann is Technical & Regulatory Director with CONUS Business, Advice & Training (CONUSBAT), and a provider of internationalization services for the Fine Chemicals, Cosmetics & Toiletries, Food and Pharmaceutical Industries: www.conusbat.com. In 2003, she joined the firm and, based on many years of experience gained while working with the international industry, she established the service area for regulatory affairs.
For more information please click here


Mgr. Rinat Bacher

MOH, IsraelMrs. Rinat Bachar, is a qualified pharmacist. In her current position for 14 years she serves as the head of the cosmetics & biocide regulation & registration division of the Pharmaceutical administration in the Israeli Ministry of health. In this capacity she is responsible and supervises cosmetic regulation policy and registration.
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Mr. Steven L. Hanft

M.A., President, CONUSBAT.
As President of CONUSBAT, and with its mission to facilitate internationalization processes in companies, Mr. Hanft provides regulatory and market development services to the global community. Located in North Rhine Westphalia, Germany, CONUSBAT focuses on REACH and cosmetics legislation; thus providing all services for compliance, e.g. OR, RP
For more information please click here


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