Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age

Abstract

Following a request from the European Commission to EFSA, the EFSA Scientific Committee (SC) prepared a guidance for the risk assessment of substances present in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the EFSA SC took into account, among others, (i) an exposure assessment based on infant formula as the only source of nutrition; (ii) knowledge of organ development in human infants, including the development of the gut, metabolic and excretory capacities, the brain and brain barriers, the immune system, the endocrine and reproductive systems; (iii) the overall toxicological profile of the substance identified through the standard toxicological tests, including critical effects; (iv) the relevance for the human infant of the neonatal experimental animal models used. The EFSA SC notes that during the period from birth up to 16 weeks, infants are expected to be exclusively fed on breast milk and/or infant formula. The EFSA SC views this period as the time where health-based guidance values for the general population do not apply without further considerations. High infant formula consumption per body weight is derived from 95th percentile consumption. The first weeks of life is the time of the highest relative consumption on a body weight basis. Therefore, when performing an exposure assessment, the EFSA SC proposes to use the high consumption value of 260 mL/kg bw per day. A decision tree approach is proposed that enables a risk assessment of substances present in food intended for infants below 16 weeks of age. The additional information needed when testing substances present in food for infants below 16 weeks of age and the approach to be taken for the risk assessment are on a case-by-case basis, depending on whether the substance is added intentionally to food and is systemically available.

Re‐evaluation of mono‐ and di‐glycerides of fatty acids (E 471) as food additives

“…The Panel noted that in Annex II of Regulation (EC) No 1333/2008, use levels of mono‐ and di‐glycerides of fatty acids (E 471) in food for infants under the age of 12 weeks are included in category 13.1.1, 13.1.5.1 and 13.1.5.2. The Panel considered that these uses for infants under the age of 12 weeks would require a specific risk assessment in line with the recommendations given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (1978), the SCF () and EFSA (EFSA Scientific Committee, ). Therefore, the current re‐evaluation of mono‐ and di‐glycerides of fatty acids (E 471) as a food additive is not applicable for infants under the age of 12 weeks.…”

“…According to the definition above, the ADI as established for the general population does not apply to infants below 12 weeks of age (JECFA, ; SCF, ). In this context, the re‐evaluation of the use of food additives in food for infants below 12 weeks represents a special case for which specific recommendations were given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (JECFA, , ), by the SCF (SCF, , ) and EFSA (EFSA Scientific Committee, ). The Panel endorsed these recommendations.…”

Re‐evaluation of hydrochloric acid (E 507), potassium chloride (E 508), calcium chloride (E 509) and magnesium chloride (E 511) as food additives

“…On 31 May 2017, EFSA published a guidance document on the risk assessment of substances present in food intended for infants below 16 weeks of age enabling EFSA to assess the safety of food additives used in foods for infants below 16 weeks of age (EFSA Scientific Committee, 2017). Therefore, the current evaluation addresses all population groups, including the infants below 12 or 16 weeks of age following the principles outlined in that guidance.…”

Re‐evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono‐ and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a‐f) as food additives

“…However, the ADI as established for the general population does not directly apply to infants below 12 weeks of age (JECFA, 1978;SCF, 1998a). In this context, the re-evaluation of the use of food additives in food for infants below 12 weeks represents a special case for which specific recommendations were given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (JECFA, 1972(JECFA, , 1978 and by the SCF (SCF, 1996(SCF, , 1998a and EFSA (EFSA Scientific Committee, 2017). The Panel endorsed these recommendations.…”