The term "pharmacologically active substances" is used about all substances that are included, or could potentially be included, as an active ingredient in a medicine1. Since this means that these substances have a specific biological effect, there is also a potential risk in their use (and possible misuse). While side effects are acceptable to a certain degree with medical use, they are not acceptable with the use of cosmetics, which under normal foreseeable sircumstances should be safe for lifelong used by everyone.
For a long time, the Norwegian Food Safety Authority has wished to see EU regulation of these substances in cosmetics. However, in lack of a regulation, we have found it necessary to evaluate the safety of some of these substances.
In order to more closely examine the risks associated with "pharmacologically active substances" in cosmetics, the Norwegian Food Safety Authority has reviewed the available information relevant to a whole range of such substances. The substances were chosen on the basis of a former, national Norwegian regulation, which had to be discontinued with the implementation of the EU's new Cosmetics Regulation (EU) No. 1223/2009 on 11 July 2013.
A risk profile has been established for each of the substances that has been evaluated by the Norwegian Food Safety Authority. A risk profile is a simplified risk assessment that is intended to give a sufficiently thorough documentation of risk to enable the Norwegian authorities to decide what constitutes safe use of these substances. The risk profiles have been produced in accordance with EU criteria covering cosmetics in the SCCS2 notes of guidance.
A review of the risk profiles indicates that nearly all of the "pharmacologically active substances" should be regulated with limit values, labelled or prohibited in order to satisfy the requirement of article 3 of the Cosmetics Regulation: "A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use". We are now communicating this information to Norwegian industry, so that they are aware of our evaluation of the risks involved, and as an aid to fulfilling the requirements of article 3. The risk profiles are openly at this website. Here we also provide summaries of the risk profiles, aimed at industry and consumers respectively. The information aimed at industry contains both substances that we believe cannot be safely used in cosmetics and substances that we believe can be used with certain use limitations. The information aimed at consumers only contains substances that we believe to be unsafe and that should not be used, since consumers have no information about the quantities of the various ingredients in the products they buy.
The substances that have now been evaluated represent only a limited selection of all the "pharmacologically active substances" regularly use in cosmetics and that have not yet been regulated with limitations of use in the EU. The Norwegian Food Safety Authority believes that this could indicate that "pharmacologically active substances" are generally not well enough regulated in cosmetics in the EU. The hope is that this will help to put the spotlight on unregulated use of "pharmacologically active substances" in cosmetics.
1All substances, drugs and preparations that can be given to people or animals in order to re-establish, change or affect physiological functions.
2SCCS stands for Scientific Committee on Consumer Safety. This is one of several scientific committees that have been established to assist the European Commission in its work of helping to ensure that products offered on the European market are safe for consumers.
Questions and comments ca be directed to The Norwegian Food Safety Authority, Head Office, Section for Consumer Affairs:
Hans Jørgen Talberg, tel. +47 23216749
Ingrid Stavenes Andersen, tel. +47 23216509