Regulatory Affairs

The selection of case studies below are examples of projects conducted by FoodWrite Ltd on regulatory affairs and aspects of legislation. If there is something in these case studies which would help you pursue or resolve your objectives, please contact FoodWrite Ltd. The clients cannot be identified in all cases but have given permission for the subject matter to be identified in the generic format.

Maxinutrition Specifications (2013-2014)….A project where all the Finished Product Specifications (nearly 150 in all) for all Maxinutrition products were rewritten for GSK. Full documentation was completed including analytical, allergen advice, microbiological risk analysis, nutritional and packaging specifications were set. Agreement on methods of manufacture were completed with.all contract manufacturers.  

Food Contact Materials (Project No. 0F22)…Advice and assessment on food contact material coatings especially the substance poly(vinyl alcohol) for a US capsule producer looking to extend into specific EU countries. The review covered the European food contact material legislation (EC 10/2011) and material types not covered by EC 1935/2004. A more specific respect examined the use of PVA grafted forms as coating agents in capsules (Year 2019). The sponsor was able to make commercial judgements about the use of particular polymeric capsules for sports supplements.

Cider vs. Made Wine Taxes in the UK (Project No. 3T68)… report on HMRC view, tax and distinctions between various cider and made wine products for UK market (Year 2016).

Overview of regulatory processes for Qatar, UAE and Saudi Arabia (Project No. 5T67)…in collaboration with an FMCG regulatory affairs manager assessing dietary supplements, including their specifications and Halal status. Foodwrite Ltd. produced documentation to support new introductions (GlaxoSmithKline Consumer Healthcare Year 2014-2016).

Overview On Food Contact Materials for a US SME food manufacturer (Project No. 2Z34). The overview covered food safety regulations regarding contact materials in food processing and storage. The specific request was a comparison between Code of Federal Regulations (CFR) specifically under the title CFR Title 21 and EC 1935/2004 with reference to new polymer formulations and their food contact approval. The study led to costs being estimated in meeting these safety regulations and on the filing of exemptions (Year: 2015).

Intepretation Of The European Biocidal Product Regulation (EU BPR) In The Use Of Chlorine Dioxide (Project No. 0J71).

This short consultation covered the effect of chlorine dioxide in food grade starch production. The biochemical mechanisms were also covered as were regulatory requirements for a unique and new process. Article 95 was the main focus and allowed the client to establish a design for their process which did not contravene these regulations (Year 2014-2015). 

Claims development for various new ingredients – assessment (Project No. 8H08)…. review of EFSA process for submission of documents relating to some fibre ingredients. Customer wanted overview of process of submission (Year 2013-2014).

Preservative levels in beverages (soft drinks) – report (Project No. 3D56)…. assessment of sodium benzoate, potassium sorbate and combinations for a product developer checking levels at end of shelf-life of product. Products were destined for tropical storage.