Retinyl palmitate

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

other: Review

Adequacy of study:

other information

Reliability:

other: not applicable

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Tolerable upper intake levels for vitamins and minerals

Author:

Scientific Committee on Food

Year:

2006

Bibliographic source:

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178633962601.htm

Reference 2

Reference Type:

review article or handbook

Title:

SCIENTIFIC OPINION: Consequences for the consumer of the use of vitamin A in animal nutrition. Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed

Author:

EFSA

Year:

2008

Bibliographic source:

The EFSA Journal; 873; 1-81

Results and discussion

Any other information on results incl. tables

2006:

The scientific opinions presented in this compilation were developed at the request of the European Commission by the Scientific

Committee on Food (SCF) (up to April 2003) and the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) of EFSA

(May 2003 to 2005). The context of this request was the need for scientific advice on the safety of vitamins and minerals to support the

implementation of impending harmonized EU legislation for food supplements and fortified foods, and particularly to assist with the

setting of maximum limits for micronutrients in these products.

These opinions present comprehensive evaluations of possible adverse health effects of individual micronutrients at intakes in excess of

dietary requirements and, where possible, establish Tolerable Upper Intake Levels (UL) for different population groups. The approach

taken was based on the principles of scientific risk assessment.

2008:

The fat soluble vitamin A is required in humans and animals. It is essential for vision, growth

differentiation and proliferation of a wide range of epithelial tissues, bone growth,

reproduction and embryonic development. Vitamin A is present in the diet as preformed

vitamin A (retinol and its esters) and can also be derived in humans and most animal species

from dietary carotenoids, mainly ß-carotene. Vitamin A accumulates in the body, particularly

in liver, and is toxic at high doses in most species studied. The use of vitamin A as a feed

additive is currently authorised under Regulation (EC) No 1831/2003 as nutritional additive

with maximum contents for a number of animal categories and types of feedingstuffs.

Two reports, one from the UK’s Scientific Advisory Committee on Nutrition (SACN) and the

other from the Agence Française de Sécurité Sanitaire des Aliments (AFSSA), both

published in 2005, drew attention to the risks of high levels of vitamin A for the consumer

resulting from the intake of products of animal origin.

The Commission asked the European Food Safety Authority (EFSA) to review those reports.

Should the overall intake exceed the tolerable upper intake level (UL) for vitamin A, EFSA

should comment on the benefit of decreasing the maximum permitted levels of addition for

vitamin A. In addition, EFSA should also advise on the potential zootechnical implications of

lowering the levels of vitamin A intake by food-producing animals. In that respect,

consequences for the safety of target animals and the environmental impact should be

assessed.

The UL set by SCF (3 000 μg RE from preformed vitamin A day-1) was considered by the

Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) as still being

appropriate, taking into account the available data. Quantitative correlations between retinol

intake and bone health risk justifying the establishment of a lower UL for a specific

population subgroup (elderly people) could not be established. A maximum intake of 1 500

μg RE day-1 would therefore — until new data indicates the necessity of a re-evaluation —

serve as a guidance level (GL) for persons at a greater risk of osteoporosis and bone fracture

(particularly postmenopausal women).