Bach flower remedies

• According to the Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety, Article 14, "food shall not be placed on the market if it is unsafe". According to Article 14, section 4 of EC 178/2002: In determining whether any food is injurious to health, regard shall be had:  (a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations; (b) to the probable cumulative toxic effects.

We prepare safety assessments for Bach flower remedies with the status of food in accordance with the EC general food law regulation 178/2002 to demonstrate their safety.

• According to article 8 of Directive 2001/83 EC, in order to obtain an authorization to place a medicinal product on the market, the application shall be accompanied by documents on toxicological and pharmacological tests and clinical trials, submitted in accordance with Annex I.

  We compile non-clinical and clinical expert reports on the safety and of Bach flower remedies with the legal status of a medicinal product by presentation in accordance with Directive 2001/83 EC.