Registration Dossier

Administrative data

Description of key information

No repeated dose toxicity study is provided because due to the nature of the substance, Algifert solid K+ is not deemed to pose any toxicological hazard. This approach was also intended to avoid unjustified animal testing.
Detailed justification provided in the discussion section.

Key value for chemical safety assessment

Additional information

Algae and algal products are used as food for humans and animals: about 60 out of the 20000 species of algae described so far are widely used in the food, pharmaceutical and cosmetic industries. The brown algae belonging to the genus  Ascophyllum are included.

The dominant use of brown algal seaweed is for the production of phycocolloids such as alginates. In cosmetology, alginates extracted from Ascophyllum are used as emulsifiers and emulsion stabilizers in creams and lotions, as excipients absorbable by the epidermis, in preparations such as gels, creams, shampoos. Alginates are recognized world-wide as products that may be used freely in foodstuffs as emulsifying or stabilising agents. Accordingly, they are considered safe for use in skin applications and are well tolerated (Y. De Roeck – Holtzhauer, 1991, 4 Uses of Seaweeds in Cosmetics, in Seaweed resources in Europe: Uses and Potential).

The brown algal seaweed is used also in animal and human nutrition; in particular Ascophyllum nodosum is used as seaweed meal in,,(where it is also sold as health food in tablets or gelatine capsules),.

Animal nutrition: the most common seaweed source in animal nutrition in Europe is Ascophyllum nodosum; most data on its use are from Norway where it has been used sincefeeding stuff for poultry, chick and hen trials, sheep, cattle, pig, horses, mink and as a supplemental fodder for poultry, pig, cattle and sheep in Iceland, Scotland, Ireland, Norway, Finland, France, New Zealand (W. A. Stephenson, 1973. 10 Seaweed meal as feeding stuff, in Seaweed in agriculture and Horticulture).

Human nutrition: the use in human nutrition is more common in Far East, particularly,and, where the population eat more seaweed than in the West for both nutritional and industrial purposes.is now the European country where seaweeds are used in human nutrition at the highest level. A. nodosum and L. digitata are among the species used due to their ability to regulate bowel action, as source of amino acids and protein, vitamins and minerals and low fat content.

Furthermore, seaweed extracts including Ascophyllum nodosum extracts are included in Annex I of Directive 91/414/EEC, which requires a reduced package of studies for Plant Protection Products made from plants or plants extracts (SANCO Draft Working Document 10472/2003/rev. 5). According to this document, for algal species used in food and feed, oral toxicity tests may be waived.

Justification for classification or non-classification

Based on the weight of evidence, it is proposed that Algifert solid K+ is not classified for long term health risk.