Safety of Beta‐lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on beta‐lactoglobulin (BLG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF (≥ 90% w/w dry matter protein) consists of BLG as primary component (≥ 90% of total protein), which is equivalent to BLG present in bovine milk and whey protein isolate (WPI). The NF is produced from bovine whey by crystallisation under acidic or neutral conditions. The NF is proposed to be used as a food ingredient in isotonic and sport drinks, whey powder and milk‐based drinks and similar products, and in food for special medical purposes as defined in Regulation (EU) No 609/2013. The target population is the general population. The highest daily intake of the NF was estimated for children of 3 to < 10 years of age as 667 mg/kg body weight (bw) per day. The NF presents proximate composition and content of essential amino acids similar to those in WPI. The Panel notes that the highest mean and highest 95th percentile daily protein intakes from the NF are below the protein population reference intakes for all population groups. Although a tolerable upper intake level has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The exposure to the reported minerals does not raise concerns. The Panel considers that the consumption of the NF is not nutritionally disadvantageous. No genotoxic concerns were identified from the standard in vitro test battery. No adverse effects were observed in the subchronic toxicity study, up to the highest dose tested, i.e. 1,000 mg NF/kg bw per day. The Panel concludes that the NF is safe under the proposed conditions of use.

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

“…In a few cases, food additives (e.g., soy lecithin in beta-lactoglobulin) or bulking agents (e.g., maltodextrin in xylo-oligosaccharides (XOS)) are added into the final formulation of the NF for technological purposes. The end-products are commercialized in powder form (i.e., Galactooligosaccharides (GOS), as (concentrated) syrups/liquids (cocoa pulp), crystals (anhydrous or monohydrate betaine), or dried whole products (coffee husk (cascara) and coffee cherry pulp)) ( 23–27 , 29–32 , 36 ).…”

“…In the case of NF, the data should cover at least the intended shelf-life, and the data requirements may differ depending on the nature of the NF. For instance, when the NF is prone to microbiological deterioration, its microbiological stability during the shelf life has to be investigated, as in the case of beta-lactoglobulin ( 36 ). In the case of re-evaluation of L(+)-tartaric acid (E 334) as an FA, it was noted that the stability of the tartrates depends on the alcohol content, pH, and temperature, as well as interactive effects of the solution matrix with the cations (K and Ca) and the bitartrate/tartrate anions.…”

“…The safety data and the exposure assessment of NF shall cover all population groups (Commission Implementing Regulation (EU) 2017/2469, article 5). Most of the NF derived from a by-product were proposed for the general population as ingredients in several food categories, such as spent grains from barley ( Hordeum vulgare ) and rice ( Oryza sativa ), beta-lactoglobulin, coffee cascara, rapeseed powder or XOS, or for specific population groups as in the case of betaine as NF (sports people above 10 years of age) or rapeseed powder (individuals above 1 year of age) 25 ( 23 , 27–29 , 33 , 36 ). Information on whether the NF is intended to replace another food and the proposed average and maximum daily intakes for different age/gender groups as appropriate need also to be provided.…”

“…According to the EFSA NDA Panel, NF derived from allergenic foods, including processing aids, listed in Annex II of Regulation (EU) No 1169/2011, 28 should be labeled, as they are assumed to retain the allergenicity potential of the source, regardless of the amounts of final protein content in the NF. This rationale was applied for the safety evaluation of shrimp peptide concentrate ( 34 ), spent grains from barley ( Hordeum vulgare ) and rice ( Oryza sativa ) ( 28 ), bovine milk basic whey protein isolate ( 37 ), and beta-lactoglobulin (BLG) ( 36 ). For example, the NDA Panel considered the egg membrane hydrolysate to be potentially allergenic due to its egg origin, despite the negative results when testing the hydrolysates in a radio-allergo-sorbent-inhibition assay and an in-vivo sensitization assay on guinea pigs ( 35 ).…”

“…For example, the NDA Panel considered the egg membrane hydrolysate to be potentially allergenic due to its egg origin, despite the negative results when testing the hydrolysates in a radio-allergo-sorbent-inhibition assay and an in-vivo sensitization assay on guinea pigs ( 35 ). The same consideration was made when the NDA Panel recommended that the BLG produced with soy-lecithin as an emulsifier be labeled as soy allergens ( 36 ).…”