BACKGROUND 
Ir Theo van Rooij      
                                        

  • Consultancy
        From 1992 as Company Rivendell Consultancy.
        Consulting activities for several Dutch and international companies concerning 
        - strategy food supplements due to changing regulatory situation for food supplements in EU
        - label texts and brochures for food supplements and herbal products 
        - preparation new distribution network in EU for unique herbal products
        - check the novel food status of ingredients,
        - contact with authorities to get a registration as herbal medicinal product
        - check the legal possibilities of herbal ingredients / functional foods / medical food,
          dietetic food for medical use.

     Specialities:        long term strategy,
                              practical solutions for legal / regulatory problems, 
                              creative product innovations, 
                              clear attractive health claims within the law, 
                              contact with authorities
                              network of specialists in the regulatory area of food supplements in the EU. 
     
    • Main projects in 2010/2011/2012/2013:
      - labelling of super and raw foods
      - labelling and Novel Food issues for herbal products based on Ayurveda
      - what to do with on hold claims for botanicals / timing
      - HACCP for distributors of food supplements
      - evaluation health claims in view of the new list of approved and rejected claims by the EU,
        to be implemented by 14 december 2012
      - regulatory situation sport supplements
      - labelling animal supplements
      - possibilites herbal products as medical device
      - finding a Dutch distributor for a line of medical devices for the eye
      - notification of a medical food
      - strategic advice for food supplements companies in EU
      - finding distributors in the EU for a Traditional Herbal Medicinal Product
      - strategy herbal products within food and/or medicinal law and / or as medical device
      - check supplement formulations from the US if these products can be sold in the Netherlands / EU
      - labeling of several series of food supplements from the US
      - Novel Food problems of some South American / Chinese food / herbal ingredients
      - regulatory aspects of essential oil / aromatherapy products
      - formulations and label texts for several herbal tea lines
      - preparation of registration of Chinese formulations as traditional herbal medicinal products THMP
        within 2004/24/EC or as herbal supplements within Food Law
      - finding distributors for new herbal products and medical devices in the EU
      - fomulation and labelling of food supplements for children
      - possibilities of products as medical food
      - controll of websites after problems with VWA / Dutch Food Inspection re. the claims
      - setting up of a simple and practical HACCP system for distribution of food supplements
       
      • Consulting NPN (Dutch Health Food Assocation) 2005 - 2007 regarding
             - Masterfiles for botanical products  re. quality, safety and efficacy.
             - Generic list of health claims for active ingredients in food supplements as part of the new EU Directive
               Nutrition and Health Claims 
             - Consulting KAG re. the proper use of health claims.
             - 2009: self-regulation of health claims in the Netherlands: future and strategy
         
        • Boardmember and member Commission of Specialists KOAG/KAG 1995 - 2007
           
          • Chairman NPN, Dutch Health Food Association     1988-2005 
            NPN became the leading health food association in the Netherlands with more than 100 members! 
            Involved as chairman NPN with EHPM and all issues regarding lobbying and new developments during 
            that period at the national and EU level.
                Important issues in this period:
               - Self-regulation system health claims for food supplements (KAG, www.koagkag.nl)).
               - Safety aspects for herbal products, vitamins and minerals (maximum daily dosage).
               - Novel Food: new ingredients on the EU market.
               - Safety dossiers for new vitamin and mineral substances to get derogation in the EU.
               - Herbal /Botanical ingredients within Food Law as wel as Traditional Herbal Medicines under Medicinal Law.
               - Doping risk of food supplements, system for doping free supplements NZVT, dutch doping testing system
               - Labeling requirements in order to fulfill EU Directive Food Supplements 2002/46/EC.
               - Substantiation of claims for herbal products.
               - keeping in the market of St. Johns wort as food supplement by a warning statement
             
            • Managing and Marketing Experience    1978 - 1991          
                  Smits' Reform / Pharmafood / Zonnatura
                  1978-1985  Manager R & D and QA
                  1985-1991  General Manager Pharmafood (food supplements) and Manager Regulatory Affairs
                                    and R & D Zonnatura (health food)
               
              •  Education
                     1977  Human Nutrition                 Wageningen University, Wageningen, The Netherlands
                     1970  Food Technology                HAS,  Den Bosch, The Netherlands

               

               

               

               

               

               

               

               

               

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