Vereinigung der am Drogen- und Chemikalien-Groß- und Außenhandel beteiligten Firmen e.V.
VDC
Wahrung und Förderung der fachlichen Belange und Interessen der Mitgliedsfirmen, die sich mit der Einfuhr, Ausfuhr, dem Transithandel und der Herstellung von chemischen und pharmazeutischen Rohstoffen, Nahrungsergänzungen, Zusatzstoffen, ätherischen Ölen und pflanzlichem Rohmaterial (Drogen) für die pharmazeutische Verwendung und Lebensmittelzwecke befassen.
ID: 660181152464-81
Lobbying Activity
Response to Food and Feed Safety Simplification Omnibus
13 Oct 2025
Key messages Clear Separation of Pesticide and Contaminant Law - Reg. (EC) 396/2005 & Reg. (EU) 2023/915 Authorities must not apply the pesticide default MRL of 0.01 mg/kg automatically to substances that fall within the scope of the Contaminants Regulation (EU) 2023/915; assessment must be based on legal scope and the substance's origin. Food-safety decisions for contaminants that are not pesticide residues must be driven by toxicological risk aspects (General Food Law) rather than by simple application of the pesticide default MRL. An analytical result above 0.01 mg/kg where the default MRL is not applicable should not automatically trigger withdrawal or recall unless a toxicological assessment shows an actual risk or a specific legal maximum applies. Avoid Legal Overlap - Reg. (EC) 396/2005 & Reg. (EU) 231/2012 The regulatory framework must avoid inconsistent application of pesticide MRL rules to substances regulated by the Food Additive Specifications Regulation (EU) No 231/2012. Example cases (chlorate in Xanthan gum; ethylene oxide in food additives) show that enforcement practice can misapply pesticide rules to additives. Where the legal scope of the Pesticides Regulation does not cover a product, the pesticide default MRL should not be invoked. All enforcement criteria should be contained in Regulation 231/2012 or implementing acts; in absence of an additive-specific MRL a toxicological assessment under Art. 14(2) of Reg. 178/2002 should determine the response. Proportionate Novel Food Procedures - Reg. (EU) 2015/2283 Novel-food authorisations should be proportionate: for traditional plant extracts with established safe history, expedited or simplified procedures (e.g., reduced data packages, clearer equivalence rules for extraction methods) should be available. The Commission should provide objective criteria for what constitutes a significant change compared with traditional use to avoid arbitrary re-classification of longstanding ingredients as novel. Practical and Proportionate Organic Import Rules - Reg. (EU) 2018/848 Import rules must balance consumer protection with practicability: investigations and sanctions should be triggered only by justified, evidence-based suspicions. Analytical threshold guidance is necessary (taking LOQ/LOD and multi-source substances into account) to avoid disproportionate sanctions for trace contamination from drift, transport or natural background. The Organic Farming Information System (OFIS) and TRACES procedures should distinguish between occasional minor findings and systemic non-compliance; procedures and timeframes for closure of investigations must be defined. Transparent and Feasible Import Controls - Reg. (EU) 2019/1793 Temporary increased controls can be proportionate, but the criteria determining control frequencies (Annex I) must be transparent and based on objective, up-to-date risk indicators. Where official certificates from the country of origin are unavailable, alternative EU-acceptable procedures must be allowed (e.g., EU-based official inspection under customs custody, or testing by a laboratory accredited in both origin and EU). This avoids de facto import bans (e.g. vanilla extract) and permits verification that the original risk justification still applies. Streamlined Reauthorization for Feed Additives - Reg. (EC) 1831/2003 Reauthorisation procedures for feed additives must be time-limited and predictable; data requirements should correspond to the requirements in force at the time of submission and not be retroactively expanded. Establish reduced information obligations for additives with well-documented, long-term safe use to reduce administrative burden and unnecessary costs (e.g. additives used for food).
Read full response19 Feb 2025
VDC statement on COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13994-Veterinary-medicines-rules-on-good-manufacturing-practices_en COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14388-Veterinary-medicines-rules-on-good-manufacturing-practices-for-active-substances-used-as-starting-materials_en
Read full responseResponse to Uniform rules on good manufacturing practice for veterinary medicinal products and active substances
19 Feb 2025
VDC statement on COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13994-Veterinary-medicines-rules-on-good-manufacturing-practices_en COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14388-Veterinary-medicines-rules-on-good-manufacturing-practices-for-active-substances-used-as-starting-materials_en
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