The Chairman, Prof. Kemper, welcomed the
participants of the meeting (see annex) and
introduced as guest speaker Dr. David
Basketter who was invited for a presentation
and discussion on 'Fragrance materials, the
phenomenon of quenching'.
Apologies were received from some members of
the SCCNFP (see annex)
0. Lecture on 'Quenching - a review in
relation to fragrance allergy' Dr. David
Basketter
In the framework of the safety evaluation of
fragrance materials, Dr. Basketter was invited
to illustrate the phenomenon of quenching.
The concept is that skin sensitisation can be
blocked by a suitable "antagonist" - which may
also be a scent - present at an appropriate
concentration. However, examination of
quenching pairs has failed to find any
evidence of (physico-)chemical interactions
which would explain the phenomenon of
quenching. Nor could quenching be demonstrated
at the level of skin reactions at either
induction or elicitation in any guinea pig/murine
skin sensitisation models or at the level of
elicitation in allergic subjects.
Although there is no convincing scientific
evidence that quenching occurs or a clear
hypothesis for why it should, certain
observations imply that there may be a
phenomenon which is worthy of further careful
investigation.
The presentation was followed by a discussion,
and in particular on sensitisation testing on
human volunteers in the light of ethical
premises.
1. Declaration of interest
No interests were declared.
2. Adoption of the Agenda (doc. n° SCCNFP/0253/99)
(Annex 1)
The agenda was adopted.
3. Approval of the minutes of the 9th
plenary meeting of 30 September 1999
doc. n° SCCNFP/0204/99
The minutes were adopted.
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno, presented the
following items :
- the updating of the notes of guidance
concerning the definition of and the data on
consumer exposure to cosmetic ingredients, in
particular the exposure to preservatives, UV
filters and hair dyes;
- preparatory work on an additional annex to
the notes of guidance concerning the physical
and chemical specifications of new ingredients
including ingredients derived from plants or
animal tissues;
- the use of human volunteers for the skin
compatibility testing of potentially cutaneous
irritant ingredients or mixtures of
ingredients. A draft opinion was prepared on
the issue;
- the use of human volunteers for the testing
of potentially sensitising ingredients or
mixture of ingredients. The main point of
concern is the ethical aspects;
In his report, the Co-ordinator mentioned as
well that it was regrettable that DG Research
approved only one research project in the
framework of the 'Cell factory' research
programme. He regretted that no appropriate
response was given to the call for an
extensive research programme on development of
alternatives to animal testing.
A draft opinion on :
Basic criteria of the protocols for the skin
compatibility testing of potentially cutaneous
irritant cosmetic ingredients or mixtures of
ingredients on human volunteers, doc. n°
SCCNFP/0245/99, rev. 2
In the framework of the recently adopted
guidelines on the use of human volunteers in
the testing of potentially cutaneous irritant
cosmetic ingredients or mixture of
ingredients, the Working Party prepared a
document which specifies the basic criteria
for study protocols for skin compatibility
testing of such ingredients or mixture of
ingredients. The document did intentionally
not go into all the details of the study
design as there is at present no standard
study design. Therefore, the document
specifies the more general criteria, and
consequently limits, applicable to the various
study designs.
The document states that the study protocol
should contain, amongst others, information on
the purity of the ingredients and on the
nature of the vehicle. In this respect, Prof.
Loprieno mentioned that the Working Party is
considering these issues in view of a possible
inclusion in the Notes of Guidance. He said
that the item is on the agenda of the next WP
meeting, scheduled on 31 January 2000.
As a result of the discussion, the document
was adopted by the plenary meeting. It will be
included in the Committee's Notes of Guidance
for Testing of Cosmetic Ingredients for their
Safety Evaluation.
In the margin of the discussion, Prof. Kemper
suggested the Commission to send a copy of the
document to the Commission's Ethical Committee
(SG).
4.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen mentioned the
following items :
- on 18 -20 October, a Special Task Force
meeting took place during which 15 draft
opinions were prepared. 13 of these draft
opinions were discussed by the Working Party
on 7 December. The WP approved 5 draft
opinions and addressed them to the next
plenary for formal adoption. On the 8
remaining draft opinions, additional data were
requested from industry.
2 draft opinions were postponed to the next WP
meeting.
- the SCCNFP was requested to evaluate the
risk of amino acids derived from human hair
hydrolysates with regard to the transmission
of Creutzfeldt Jakob Disease, transmissible
human spongiform encephalopathies and viral
diseases. The use of this material as cosmetic
ingredients is at present prohibited by entry
416 of Annex II of the cosmetics directive.
The request seeks a potential modification to
entry 416 of Annex II. A rapporteur was
assigned who will report in a future meeting.
- elucidations on some recently adopted hair
dye opinions were asked by the Austrian
Delegation. The questions asked will be dealt
with in the next WP meeting.
4.3 Inventory
Report of the Co-ordinator
In his report, the co-ordinator, Prof. Parra,
said that no meetings were organised since the
previous plenary meeting of 30.9.99, but that
work will resume upon receipt of the final
draft of the 1st update of the inventory.
As it was said that the final draft would be
available by mid-December, a meeting was
planned on 20 December 1999 to consider the
document and to decide on how to proceed in
view of its adoption by the plenary.
4.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, the Co-ordinator, Dr. White
informed the plenary about a letter received
from a company requesting the Commission to
freeze the procedure to put the SCCNFP opinion
concerning Ketoconazole into legislation, to
discuss the SCCNFP opinion with their experts
and to revise the opinion by limiting the use
of the chemical up to 1.0% in rinse-off and to
0.5% in leave on products.
Dr. White asked the committee members to
comment on this. As a result, the SCCNFP
restated the opinion adopted and requested the
Commission to respond to the firm in that
respect.
Draft opinions on Musk Ketone and Musk Xylene
Dr. White introduced the issue saying that the
Plenary meeting of 30 September 1999 decided
to refer the draft opinions on Musk Ketone and
Musk Xylene back to the Working Party as there
was still concern about carcinogenicity, their
accumulation in mother's milk and an
acceptable concentration in the finished
product. All members were invited to go
through the document and to respond with any
questions regarding information they would
like to see or any points for clarification
they would like to raise.
Two more Working Party meetings were organised
during which the comments received from the
members were discussed and the opinions
redrafted. The final drafts were tabled for
formal adoption.
Musk Xylene, doc. n° SCCNFP/0162/99, rev. 5
As the draft opinion has already been
discussed in detail during previous meetings,
the discussion today focussed mainly on the
wording of the opinion. The committee stated
that the aim of the opinion was a reduction in
consumer exposure to Musk Xylene of about 50%.
The basis to achieve this was the estimated
exposure to Musk Xylene of about 207 μg/kg bw/day,
which equated to about 20.7 μg/kg bw/day
absorbed. As it was not possible to identify a
threshold dose from the mice tumour data, the
committee said that the absorbed dose of Musk
Xylene from exposure to cosmetic products
should be reduced to about 10 μg/kg bw/day.
This statement was based on the quantitative
risk assessment assuming that a calculated
lifetime cancer risk of about 1 x 10-4 should
be tolerable for a non-genotoxic carcinogen.
It was recognised that the proposed reduction
could be achieved in a number of ways and the
following were given as examples :
* a maximum of 0.1 % Musk Xylene in any
cosmetic product would give a calculated
absorbed dose of about 10.3 μg/kg bw/day;
* a concentration of 1.0 % in perfume, of 0.4
% in eau de toilette and a concentration of
0.03 % in all other products would give a
calculated absorbed dose of about 10.8 μg/kg
bw/day.
The Committee stressed that the above was
formulated on review of only the cosmetic use
of Musk Xylene and that for a complete safety
assessment of Musk Xylene, also other sources
of consumer exposure from non-food products e.
g., laundry products should be considered.
The opinion was adopted by the plenary.
Musk Ketone, doc. n° SCCNFP/0162/99, rev. 5
To a certain extend, the same was said
concerning Musk Ketone, as there are a number
of similarities with Musk Xylene. The key
issue was that there were no carcinogenicity
studies available on Musk Ketone. However,
Musk Ketone is non-genotoxic and behaves like
phenobarbital (enzyme induction). So, one
might assume that there is no risk of
carcinogenicity.
The committee stated that the aim of the
opinion was also a reduction in consumer
exposure to Musk Ketone of 50%. The estimated
exposure to Musk Ketone is about 200 μg/kg bw/day,
which equates to about 28 μg/kg bw/day
absorbed. The committee said that the absorbed
dose of Musk Ketone from exposure to cosmetic
products should be reduced by about 50 % to
about 14 μg/kg bw/day and that the proposed
reduction could be achieved following the same
approaches as suggested for Musk Xylene.
Again, the Committee stressed that the above
was formulated on review of only the cosmetic
use of Musk Ketone and that for a complete
safety assessment of Musk Ketone, other
sources of consumer exposure from non-food
products e. g., laundry products should be
considered.
The opinion was adopted by the plenary.
Draft Pre-opinion concerning fragrance allergy
in consumers, doc. n° SCCNFP/0017/98
During the 9th plenary meeting of 30.9.99, the
Committee approved the draft pre-opinion
concerning fragrance allergens and requested
the Commission to put it on the internet to
invite interested parties for comments before
2 November 1999.
The comments (39) received were divided into
two groups, namely personal from individuals
suffering from allergies caused by fragrances
and comments from industry/scientists on the
issue as a whole. The committee considered
every comment and discussed their main
observations. The observations were catalogued
as follows :
- size of the problem/epidemiology
- substances about which the consumer should
be informed
- establishment of threshold concentrations
- cross sensitisation (cross reaction)
- fragrance free approach.
As a result, the committee adopted the opinion
on fragrance allergy, doc. n° SCCNFP/0017/98
without modifying its content but subject to
the insertion of an executive summary as well
as the paper 'Comments on the draft
pre-opinion concerning fragrance allergy in
consumers', doc. n° SCCNFP/0261/99 which lists
the critical comments and questions received
together with the response of the committee.
A tabulated list of the comments received and
the reply from the committee on these comments
(doc. n° SCCNFP/0261/99) are available on
request.
4.5 UV Filters
Report of the Co-ordinator
Although no further Working Party meetings
have taken place since the previous plenary
meeting of 30 September 99, the co-ordinator,
Dr Lina reported on the state of the pending
issues :
* S75 : Coated Titanium dioxide : a letter was
sent in July 99 requiring industry to respond
specifically to the questions asked. Industry
replied they will respond to each of the
questions asked before the end of the year.
Work will resume upon receipt of the data.
5. Report on the European Legal Framework
on Detergents SCCNFP/0250/99
J. Lopez Villar
Recently, the Commission's attention was drawn
to the skin problems caused by detergents or
other household products. However, the
existing legislation in this domain focuses
mainly on environmental/general health issues
rather than on possible skin diseases.
Mr. Lopez Villar presented an overview of the
EU legal framework on detergents. Two main
pieces of legislation exist, namely the
specific legislation on detergents and the
legislation on dangerous substances and
preparations.
Although, at present, the consultation of the
SCCNFP on the issue is not mandatory, it was
decided to establish a Special Working Party
and to look for additional external experts in
this field to enable the SCCNFP to answer the
respective mandates.
6. Report of the Chairman
In the light of the 6th amendment to Directive
76/768/EEC, Prof. Kemper invited the members
to reflect on the possibility to propose a
separate chapter in Annex III to the cosmetics
directive listing the pharmacological active
substances used in cosmetics with a distinct
action on the skin or its annexes.
7. Any Other Business
* The following dates were proposed for future
plenary meetings : 17 February 2000,
3 May 2000 and 28 June 2000.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr
J-F. Doré, Mr P. Elsner, Mr V. Kapoulas, Mr F.
Kemper, Mr B. Lina, Mr N. Loprieno, Mr J.
Parra, Mrs V. Rogiers, Mr T. Sanner, Mr J.
Vives Rego, Mr I. White
Mrs J.D. Johansen external expert, Mr D.
O'Mahony external expert, Mrs R. Schumann
external expert
Commission : Mrs L. Benali DG Sanco, Mrs S.
Clarke DG Sanco, Mrs M. de Solà DG Sanco, Mrs
F. Drion DG Sanco, Mr J. Lopez Villar DG Sanco,
Mr L. Norgaard DG Entr, Mr A. Van Elst DG
Sanco
Apologies : Mr P. Blain Mr Ph. Masson external
expert
Annex 1
Scientific Committee on Cosmetic and Non-Food
Products
Agenda for the 10th plenary meeting (Brussels,
8 December 1999)
0. Lecture on 'Fragrance materials, the
phenomenon of quenching'
Dr. David Basketter
1. Declaration of interest
2. Adoption of the agenda SCCNFP/0253/99
3. Approval of the minutes of the 9th plenary
meeting of 30.9.99 SCCNFP/0223/99
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Draft opinion on minimal criteria of the
protocols for the skin compatibility testing
of potentially cutaneous irritant cosmetic
ingredients or mixtures of ingredients on
human volunteers SCCNFP/0245/99 rev.1
4.2 UV Filters
Report of the Co-ordinator
* Further procedure S75
4.3 Hair Dyes
Report of the Co-ordinator
4.4 Inventory
Report of the Co-ordinator
4.5 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
* Draft opinion on Musk Xylene SCCNFP/0162/99
* Draft opinion on Musk Ketone SCCNFP/0163/99
* Fragrance Allergens SCCNFP/0017/98
5. Report on the European Legal Framework on
Detergents SCCNFP/0250/99
J. Lopez Villar
6. Report of the Chairman
7. Any other business