Erika Boriani

Indipendent management of regulatory activities in the SUPPLEMENTS, FOODS and COSMETICS sector - due to the skills gained duing the previous years

· FOOD/FOOD SUPPLEMENTS AREA - Study and monitor of the national and European regulatory framework on food supplements and particular foods, with consequent checkof regulatory compliance in terms of composition and labeling of the Company portfolio's products, of the boxes, labels and promotional materials associated with them, including social networks and Corporate's website. - Preparation of the documentation for the notification of supplements and food products for specific nutritional needs (gluten-free foods and for special medical purposes)

- Regulatory support in the scouting phases of new or alternative raw materials to those already used, with compliance check of the documentation for the individual components;

- Preparation and updating of checklists for the minimum requirements for the approval of these raw materials, based on regulatory and Company's policy requests. - Years 2011-2013: preparation of the documentation for the notification of food supplements to the national and European Health Authorities (Ireland, France, Austria, Germany and Portugal) and experience in evaluating the registration requirements of the aforementioned products at non-European Health authorities (Russia, Malaysia, Canada, Mexico, Gulf Area).

· COSMETIC PRODUCTS AREA

- Study and monitor of European regulations related to cosmetic products, with compliance check on packaging and advertising materials and on the composition of the Company products, in relation to the regulatory context and its developments.

- Regulatory support in the scouting phases of new or alternative raw materials to those already used

- Management of contacts with suppliers and manufacturers for the compliance check of the raw materials/products supplied, in light of new regulatory requirements.

- Notification of cosmetic products on the European CPNP portal pursuant to Regulation 1223/2009, and brief experience in evaluating the necessary documentation to be submitted to non-European Authorities

- Experience in requesting the assignment of the INCI name for ingredients intended for employment in cosmetics at the Personal Care Product Council.

- Knowledge of the basic concepts of REACH and CLP regulations and their applications for a company having the role of downstream user.

- Development of checklists and template documents for requesting minimum requirements to be addressed to suppliers for the raw materials used in the products on the price list, in line with mandatory legislation and/or company inspiration.

- Final comprehensive verification of the PIF pursuant to Regulation (EU) 1223/2009

SPECIALIZATION IN THE AREA OF COSMETICS, as well as (EX) DIETARY FOODS, GLUTEN-FREE AND INTENDED FOR SPECIAL MEDICAL PURPOSES, FOOD SUPPLEMENTS at a national level.
- Check on packaging compliance
- Notifications to the competent Authorities
- Monitoring of regulatory developments and transfer of regulatory alerts with potential impact on the company's business to the involved Company functions.
- Brief experience on the request for a Health Claim according to the procedure set out in art. 13.5 Reg.1924/2006

SPECIALIZATION IN THE AREA OF (EX) DIETARY FOODS, GLUTEN-FREE AND INTENDED FOR SPECIAL MEDICAL PURPOSES, FOOD SUPPLEMENTS at a national level.
- Check on packaging compliance
- Notifications to the competent Authorities.
- Monitoring of regulatory developments and transfer of regulatory alerts with potential impact on the Company's business to the involved Company's functions

INTERNSHIP AT REGULATORY AFFAIRS DEPT

• Attendance of training courses useful for acquiring skills related to the role.
• Supporting the tutor for data collection and document processing during meetings and conferences, especially regarding an authorization request as Novel Food for an ingredient of Corporate interest, pursuant to Reg.258/1997.
  Preparation of documentation, operative support to the team.
• Learning of basic regulatory activities in the field of drugs, supplements, (ex) dietary foods and for special medical purposes, cosmetic products, following the internal flow: from the idea to the development and definition of the launch of the product on the market