11 Amendments of Tiemo WÖLKEN related to 2023/2081(INI)
Amendment 12 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the NCHR was introduced with the objective to assure a high level of consumer protection possible and to facilitate consumers' choice;
Amendment 39 #
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas the Commission was supposed to adopt, according to Article 13 (3) NHCR, a community list of permitted claims by 31 January 2010 at the latest;
Amendment 47 #
Motion for a resolution
Recital K
Recital K
K. whereas the legislation on botanicals in foods and food supplements is not harmonised at EU level; whereas Member States either have positive, negative or no lists of botanical substances permitted in foods; whereas the classification of botanicals as either food or medicine lies within the competence of each individual Member State; whereas it is important to maintain a clear distinction between food and medicine as they serve different purposes; whereas the purpose of a medicinal product is to treat or prevent disease in human beings and food supplements are intended for consumers who don’t have immediate medical needs;
Amendment 50 #
Motion for a resolution
Recital L
Recital L
L. whereas herbal medicines must undergo authorisation procedures before their introduction to the EU market, necessitating the demonstration of product safety, quality and efficacy and having to fulfil additional legal requirements, such as quality assessments, pharmacovigilance and good manifacturng practice (GMP) compliance; whereas herbal medicines that have been safely used for 30 years, including 15 years in the EU, can use a simplified registration procedure for traditional herbal medicinal products, where ‘traditional use’ data is accepted to substantiate the safety and efficacy of the product;
Amendment 108 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Points out that there are significant constitutional concerns about the continued use of the ‘on-hold’ claims under the transitional measures of Article 28 of the NHCR; points out that the Court of Justice expressed in its judgement of 23 November 20171a that the Commission was obliged to adopt a list of permitted claims by 31 January 2010 at the latest and it only partially did so with Commission Regulation (EU) No 432/2012 establing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to the children's development and health1b; _________________ 1a C-596/15 P and C-597/15 P, ECLI:EU:C:2017:886 1b OJ L 136, 25.5.2012, p. 1.
Amendment 109 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Highlights the imperative need to address the ‘on-hold’ list of claims on botanicals; is concerned that the continued use of the ‘on-hold’ claims under the transitional measures of Article 27 of the NHCR could mislead consumers, who may falsely assume that the ‘on-hold’ claims have been scientifically assessed and risk managed; considers, furthermore, that the ‘on-hold’ list creates unfair competition for food business operators and discourages innovation as the uncertainty surrounding the situation deters long-term investmentsn form of further evaluation of these claims as an urgently required measure for consumer protection just as highlighted as an key result of the NHCR evaluation report commissioned by the Commission; disapproves the continued suspension of the evaluation of claims on botanicals and strongly calls on the Commission to comply - in cooperation with the European Food Safety Authority - with the legal obligations under the NHCR and to remove those claims that have already been assessed negatively from the 'on hold' list to ensure consumer protection;
Amendment 111 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Is very concerned that the continued use of the ‘on-hold’ claims under the transitional measures of Article 28 of the NHCR misleads consumers, who may falsely assume that the ‘on-hold’ claims have been scientifically assessed and risk managed, and could pose a health risk for consumers as herbal medicines and botanical food supplements based on the same plant substance(s) cannot - or only with difficulty - be distinguished by them;
Amendment 113 #
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 115 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Considers it essential to promptly review, in line with the provisions of Regulation (EC) No 1924/2006, the yet-to- be-assessed health claims related to botanicals in foods, especially for claims currently on the 'on hold list', ensuring the rejection of any previously negatively assessed claims to guarantee consumer protection;
Amendment 116 #
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 122 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Stongly calls on the Commission to enforce the NHCR in its entirety without undue delay; stresses that the European Food and Safety Authority should assess the claims on the 'on hold list' without further delay;