Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
other: EU directive
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/EC on food additives other than colours and sweeteners

Data source

Reference
Reference Type:
grey literature
Title:
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/EC on food additives other than colours and sweeteners
Author:
EU
Year:
1995
Bibliographic source:
http://ec.europa.eu/food/fs/sfp/addit_flavor/flav11_en.pdf
Report date:
1995

Materials and methods

Results and discussion

Any other information on results incl. tables

EU Directive No 95/2/EC:

According to Annex I of this directive E 471 = Mono- and diglycerides of fatty acids is listed as "FOOD ADDITIVES GENERALLY PERMITTED FOR USE IN FOODSTUFFS NOT REFERRED TO IN ARTICLE 2 (3)". Substances on this list may be added to all foodstuffs with the exception of those referred to in Article 2 (3) following the quantum satis principle.

According to Annex II of this directive (FOODSTUFFS IN WHICH A LIMITED NUMBER OF ADDITIVES OF ANNEX I MAY BE USED) the maximum level of E 471 in non-emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils)

is 10 g/L.

According to Annex VI of this directive ( FOOD ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN) the maximum level for the use of E 471 as "FOOD ADDITIVES PERMITTED IN INFANT FORMULAE FOR INFANTS IN GOOD HEALTH" is 4g/L.

Applicant's summary and conclusion