18/06/13 - Ot- Fragrance allergens- Layman version
On
European web site is available the Layman Version of the Opinion about
Fragrance allergens( SCCS/1459/11). The Layman document is a version presented
in a format and language which can be easily understood by non-specialists.
Abstract of SCCS/1459/11:
The SCCS opinion 1459/11 updates the old SCCNFP opinion with a systematic and critical review of the scientific literature to identify fragrance allergens, including natural extracts, relevant to consumers.
The studies confirm that the fragrance allergens identified by SCCNFP in 1999 are still relevant fragrance allergens for consumers from their exposure to cosmetic products. The review of the clinical and experimental data published since then shows that many more fragrance substances have been shown to be sensitizers in humans. Based on the clinical experience alone, 82 substances (see tab.13.1 of the opinion) can be classified as established contact allergens in humans, 54 single chemicals and 28 natural extracts. Of these, 12 chemicals (see tab 13.5) and 8 natural extracts were found to pose a high risk of sensitization to the consumer.
The review also lists fragrance substances that can act as prehaptens or prohaptens, forming new or more potent allergens by air oxidation and/or metabolic activation. While in the case of prohaptens the possibility of becoming activated is inherent to the molecule and cannot be avoided, the activation of prehaptens can be prevented by appropriate measures and should be considered.
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
Abstract of SCCS/1459/11:
The SCCS opinion 1459/11 updates the old SCCNFP opinion with a systematic and critical review of the scientific literature to identify fragrance allergens, including natural extracts, relevant to consumers.
The studies confirm that the fragrance allergens identified by SCCNFP in 1999 are still relevant fragrance allergens for consumers from their exposure to cosmetic products. The review of the clinical and experimental data published since then shows that many more fragrance substances have been shown to be sensitizers in humans. Based on the clinical experience alone, 82 substances (see tab.13.1 of the opinion) can be classified as established contact allergens in humans, 54 single chemicals and 28 natural extracts. Of these, 12 chemicals (see tab 13.5) and 8 natural extracts were found to pose a high risk of sensitization to the consumer.
The review also lists fragrance substances that can act as prehaptens or prohaptens, forming new or more potent allergens by air oxidation and/or metabolic activation. While in the case of prohaptens the possibility of becoming activated is inherent to the molecule and cannot be avoided, the activation of prehaptens can be prevented by appropriate measures and should be considered.
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
10/06/13 - Ot- ISO/DIS 17516
We report that an ISO method was published as DIS (Draft International Standard) version.
The objective of this International Standard (ISO/DIS 17516) is to develop acceptable quantitative and qualitative microbiological limits for cosmetic finished products.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Dead line 20/09/2013
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
10/06/13 - Ot-Update of Iso 15819:2008
We
report that an update of ISO 15819:2008 method was published as DIS
(Draft International Standard) version.
ISO 15819:2008 describes a method for the detection and quantification of NDELA in cosmetics and raw materials used in cosmetics by HPLC-MS-MS.
This method is not applicable to the detection and/or quantification of nitrosamines other than NDELA nor to the detection and/or quantification of NDELA in products other than cosmetics or raw materials used in cosmetics.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Dead line 18/09/2013
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
ISO 15819:2008 describes a method for the detection and quantification of NDELA in cosmetics and raw materials used in cosmetics by HPLC-MS-MS.
This method is not applicable to the detection and/or quantification of nitrosamines other than NDELA nor to the detection and/or quantification of NDELA in products other than cosmetics or raw materials used in cosmetics.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Dead line 18/09/2013
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
10/06/13 -OC-opinion on propyl and butyl paraben
"Parabens" are currently authorized as preservatives at a maximum concentration of 0.4% when used individually or 0.8% when used as a mixture of esters.
In March 2011, the Scientific Committee on Consumers Safety (SCCS/1348/10) considered that:
- Methylparaben and ethylparaben were safe, when used at the maximum authorized concentrations;
- Butylparaben and propylparaben were safe, if the sum of their individual concentrations did not exceed 0.19% (NOEL 2 mg/kg bw/day, the use percentage was calculated in order to obtain MOS>100).
- For isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben, the human risk could not be evaluated for lack of data.
On 21 March 2011, Denmark notified the Commission that it had banned propyl- and butylparaben, the isoforms and salts in cosmetic products for children up to three years of age. On 10 October 2011, the
The concerns of the SCCP/SCCS expressed previously and reiterated in recent Opinions remain unchanged and reinforced after the evaluation of both the reproductive toxicity and the toxicokinetic studies on propylparaben recently submitted to the SCCS. For these reasons, the SCCS reiterates its previous conclusions and requests regarding an improvement of the data, in particular:
a) on the exposure of humans including children to propyl- and butylparaben in cosmetic products and
b) the toxicokinetics of propyl- and butylparaben in humans.
Dead Line for comments:01/07/2013
Regulatory Survey Archive http://www.biophilgroup.com/elenco_news_corporate_home_tecnica.asp
