Agenda
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Preparation of a Declaration of Compliance (DoC) or an Expert Opinion Letter on Food Contact Materials (FCMs) & Food Contact Articles (FCAs): Compliance Versus Safe Use
This module will cover key aspects of the DoC requirements in the different regions (EU, US and China) by showing practical case studies to help you better understand how to apply the regulatory requirements in practice. We will also clarify some commonly misunderstood concepts held by importers/manufacturers of FCMs, or intermediary chemicals to be used in the manufacture of FCMs in relation to the DoC.
Using real-life examples, we will provide you with insights on how to prepare a DoC; this will be followed by a discussion about each of the examples used.
Together with a number of key guidance documents, prepared by specific trade industry associations in the EU, you will be given tools to help you apply your gained knowledge to real situations.
Additionally, practical examples will be presented on Expert Opinion Letters or Statements of Safe Use based on performed risk assessments.
By attending this training course, you will learn:
- which countries/regions require industry to provide a DoC for FCMs and articles;
- which type of FCM and articles require a DoC;
- what information must be provided in a DoC;
- which items should not be mentioned in a DoC;
- when to claim confidentiality (confidential business information, CBI) in a DoC;
- which additional documents are required to support a DoC;
- the penalties that a company could face where a DoC and its supporting documentation are incomplete and are therefore considered not compliant; and
- what an Expert Opinion letter or Statement of Safe Use is, and how it is based on risk assessment.
Trainer: Ms Daisy de KleinSenior Regulatory Affairs Manager, knoell NL B.V. -
Finish