IN Brief:
- The consultation covers six new novel-food authorisations and modifications involving nine existing novel foods.
- Applications include human milk oligosaccharides, astaxanthin-rich algal oleoresin, and DHA/EPA-rich Schizochytrium oil.
- A prospective UK-EU SPS agreement could replace relevant GB authorisation conditions with dynamically aligned EU rules.
The Food Standards Agency has opened consultation on 16 regulated-product applications covering novel food ingredients, while prospective UK-EU regulatory alignment creates an additional consideration for manufacturers planning how those ingredients could ultimately be used in Great Britain.
The consultation opened on 21 September and closes on 16 November. It covers six applications for new novel-food authorisations and modifications involving nine existing novel foods, including two applications relating to the same previously authorised ingredient.
A substantial part of the package concerns human milk oligosaccharides produced through specified microbial strains. Applications include different forms of 2′-fucosyllactose, 6′-sialyllactose, lacto-N-tetraose, and lacto-N-neotetraose, with proposals covering either new authorisations or changes to the conditions or specifications attached to existing approvals.
Other applications concern astaxanthin-rich oleoresin produced from Haematococcus pluvialis algae and an oil rich in DHA and EPA produced from Schizochytrium. The proposed uses span food supplements and, for several of the oligosaccharides, categories connected with infant and young-child nutrition.
The FSA has completed or considered the relevant safety assessments for the applications and is consulting on its risk-management recommendations and proposed authorisation terms. Stakeholders are being asked to comment on safety, conditions of use, labelling, and wider factors that ministers may need to consider before final decisions are made.
For ingredient manufacturers, that distinction between risk assessment and final authorisation is commercially important. A favourable safety conclusion does not by itself determine every condition under which an ingredient can be supplied. Permitted food categories, maximum use levels, specifications, and labelling requirements can decide whether an ingredient fits an existing formulation or requires additional development work.
The regulatory position is further complicated by negotiations over a Sanitary and Phytosanitary agreement between the UK and European Union. The FSA says the proposed agreement would require Great Britain to align dynamically with EU legislation falling within its scope, including market authorisations unless specific exceptions are agreed.
Under that proposed arrangement, EU-authorised products and the conditions attached to those authorisations would apply in Great Britain once the agreement entered into force. Existing GB authorisations within scope would cease to apply, meaning the final commercial conditions for an ingredient could ultimately be those set by the EU rather than those developed through the current British process.
The difference is more than administrative where permitted uses or maximum levels diverge. A manufacturer developing a product around a particular ingredient has to define recipe limits, intended consumers, label statements, supplier specifications, and technical documentation. If the underlying authorisation conditions change before or after launch, parts of that work may need to be revisited.
Infant and young-child nutrition is particularly sensitive to those details. Several applications seek additional uses involving infants or products intended for younger consumers, where compositional rules and labelling requirements are tightly controlled. The FSA specifically invites stakeholders to identify implications for the wider regulatory framework surrounding infant and young-child nutrition and feeding.
The consultation also demonstrates how fermentation technology is increasing the range of production routes available for specialist food ingredients. Several applications distinguish between otherwise similar compounds according to the microbial production strain used. That matters because authorisation can be linked not merely to the chemical identity of an ingredient but to its specification and manufacturing route.
For food producers sourcing those materials, apparently similar ingredients are therefore not automatically interchangeable. Production strain, purity specification, authorised uses, analytical documentation, and supplier quality systems can all affect whether a material is suitable for a particular finished product.
The FSA says it considered environmental, trade, societal, consumer, and technical-feasibility factors when developing its recommendations and identified no significant impacts from the proposals. Its current assessment is that authorisation should generally increase market competition and support growth and innovation, although final recommendations will take account of responses received during consultation.
The process follows separate proposals concerning earlier GB access for certain EU-authorised regulated products, reinforcing the extent to which UK food-ingredient regulation is being considered alongside future EU alignment rather than solely as a standalone domestic system.
No final authorisation decisions have yet been made. After consultation, the FSA will prepare recommendations for ministers in England and Wales, while Food Standards Scotland will make recommendations to Scottish ministers and Northern Ireland ministers will be kept informed.
Manufacturers and ingredient suppliers therefore have until 16 November to assess the proposed specifications and conditions against their own products and supply chains. The immediate issue is the content of the 16 applications; the longer-term complication is that the rules governing them may sit inside a materially different UK-EU regulatory framework by the time businesses are planning commercial use.
