U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors
October 27, 1999
FDA and the European Commission's Enterprise Directorate General
Bilateral Meeting
Cosmetics 'Breakout' Meeting
Brussels, Belgium
Summary
During a meeting between FDA and the Enterprise Directorate General of the European
Commission, in Brussels, Belgium, in October 1999, representatives of both agencies
gathered in a "breakout" meeting to discuss international activities related to cosmetics.
The subjects included the progress of a memorandum of cooperation (MOC), animal
testing, ultraviolet (UV) filters, color additives, labeling, future steps, safety issues,
priorities at FDA's Center for Food Safety and Applied Nutrition (CFSAN), safety
substantiation, and harmonization in Latin America.
Memorandum of Cooperation (MOC)
The MOC had been reviewed by the European Union (EU) and US administrations and
comments were received from FDA legal counsel. It was determined some additional
work would be needed to finalize the MOC.
In light of the development of an MOC encompassing the four administrations (US, EU,
Japan, and Canada) of the Cosmetic Harmonization and International Cooperation
(CHIC) initiative, it was decided that the current MOC would be developed as a bilateral
document that could be expanded after consideration by Canada and Japan. It was agreed
that the bilateral MOC should be implemented as soon as possible to ensure
accomplishment of specific initiatives identified at the November, 1998 bilateral meeting
and at this meeting.
Animal Testing
The US cosmetics representative described the process for validation and acceptance of
alternative methods and the role that the Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) plays in assessing the scientific soundness
of such methods for cosmetic products. It was noted that ICCVAM functions as a
scientific advisory committee that then refers alternative methods to the appropriate US
agencies and that each agency and specific agency program must consider how the
procedure should be incorporated into their public health responsibilities. The US
representatives described the different mechanisms that are available for the drug and
cosmetics programs for reviewing and recognizing alternative methods and the scope of
application. Of special significance is that the various avenues for submission and review
(ICCVAM, petitions and New Drug Application submissions) provide reasonable options
for the different regulatory structures of both the EU and US.
Because of scientific and process complexities surrounding validation and regulatory
acceptance of alternative methods in the US and the EU, it was decided that the appropriate FDA and EU technical staff should interact early in the process to ensure
consistency as much as possible. It was further suggested that the next CHIC meeting
include a possible satellite meeting among the scientists to consider mechanisms for
timely sharing of information.
The EU delegation provided a status report on the 7th Amendment to the Cosmetics
Directive. Current EU law imposes a ban on the marketing of cosmetic products containing
ingredients tested on animals beginning in July 2000. There have been a number of
proposals for changes in this requirement that contemplate either a marketing or testing
ban. The scope and impact depends, in part, on the legal interpretation of the animal
testing language in the Cosmetics Directive. EU legal experts were reviewing the
language and discussing the issue with the regulated industry.
Ultraviolet (UV) Filters
The EU is about to reach a final decision on several new ingredients from the list of
provisionally approved UV filters. There remains an interest in exchanging UV filter
approval files, although this awaits industry agreement to share information. The US
delegation suggested that avobenzone would be a good candidate for information sharing
since it was recently reviewed.
Other issues of approval and safety in both the US and EU were discussed. It was
suggested that a joint EU/US working group be established at the scientific level as early
as possible to pursue issues relative to efficacy testing with a goal of sharing information
and coordinating test procedures to the degree possible. FDA noted that time was very
important since the agency was obligated to meet legally established time frames. The
mechanisms for doing this were discussed and respective authorities would be identified
to facilitate collaboration in the identification of suitable methodologies for measurement
of high SPF and UVA protection. Another group would be established to review and
discuss the methodology for measurement of SPF. It was noted that the EU has not
established testing methods for member states and that the current approach was to employ
methods recommended by the European Cosmetic, Toiletry and Perfumery Association
(COLIPA).
Another discussion item included the pending proposed rule on additional conditions for
consideration in the over-the-counter (OTC) drug review. FDA agreed to provide copies
to the EU delegates when this is published.
Color Additives
The status of sharing information on color additive approvals in the US and EU was
discussed. This issue was awaiting completion of an MOC for protecting confidential
information. The EU delegates noted that the EU industry has been notified of the need to
agree to the release of information supporting the approval of an a typical color additive
in the EU but that a response has not yet been received. Some concern was expressed that
the EU industry may not agree to releasing safety approval information for EU approved
colors. The US delegation suggested the possibility of analyzing several different
cosmetic-grade color additives currently in use in the EU to determine their composition.
It was decided to explore this possibility further.
Labeling
The issue of cosmetic product labeling and ingredient nomenclature was discussed. The
EU delegates noted that the EU ingredient inventory was introduced about 5 years ago as
required by the Cosmetics Directive. The review committee acknowledged at the time
that there were problems with the EU Ingredient Inventory. There have been
approximately 1,500 new ingredients added to the inventory, based primarily on
information provided by COLIPA, and this new information has been reviewed and
translated. A draft update was developed about 18 months ago, with the final draft
scheduled for completion in December, 1999. An English version was scheduled for
posting on the Web at that time. The EU delegation agreed to provide an electronic copy
of the current inventory to the US delegates and also the updated inventory when it
becomes available.
The US delegates noted that they are exploring the development of a US inventory but the
issue would have to be explored with the US cosmetics stakeholders.
Future Steps
It was agreed that the US-EU bilateral discussions have proven mutually beneficial and
should continue. It was further noted that the US and EU should consider more frequent
collaborations and that these should include satellite meetings scheduled during the same
weeks as EU participation in the Cosmetic, Toiletry, and Fragrance Association (CTFA)
quarterly nomenclature meetings. To facilitate the planning and monitoring of the
various activities currently planned under the bilateral agreements, the EU delegation
agreed to prepare an activity map that will be shared with the delegates.
It was noted that the EU industry suggested that a CHIC meeting be held in conjunction
with the April 2000 Mutual Understanding Conference, but it was agreed that any
collaborations among the administrations must remain independent.
Some concern was expressed that the US-EU bilateral program should not weaken the
progress made under the CHIC program. It was noted that changes in the regulatory
schemes are underway in Japan and Canada and that the US-EU bilateral should proceed
but with an effort to keep the other partners informed of activities under the bilateral. To
this end, the US delegates agreed to make sure that all CHIC partners receive copies
of any relevant documents. The US delegates offered to host the next CHIC meeting and
suggested that it be scheduled for next May or June. The US delegates agreed to draft a letter to our
partners proposing the date and location of the next CHIC meeting. [Note: The CHIC meeting will be in
Washington, D.C., May 8-10, 2000.]
Safety Issues
The US delegates updated the EU delegates on the status of the safety review of
alpha
hydroxy acids (AHAs) and diethanolamine (DEA). It was noted that FDA intended to
complete a photocarcinogenicity study of AHAs in a newly established testing facility and
that this study will commence in the summer of 2000. It was noted that the cosmetics
industry was considering a parallel photocarcinogenicity study incorporating sunscreens
and that FDA had suggested that the additional test could be funded through the National
Toxicology Program (NTP), but study capacity was not adequate for that at this time.
It was further reported that the agency was nearing completion of a risk assessment for
DEA in marketed products and that, once completed, a decision regarding risk control
would be made. The FDA delegates also reported that an analytical method, sensitive at
the parts-per-million level, has been developed and a preliminary survey has found levels
up to approximately 0.5% DEA in finished products. FDA offered to provide a
description of the method to the EU.
The US delegates asked about the status of fragrance labeling in the EU and when a final
decision was expected. The EU delegation said that a final opinion would be provided by
the Scientific Committee for Cosmetic and Non-Food Products ( SCCNFP) in early
December, 1999. It was reported that the European industry favored a voluntary labeling
approach and that US industry would oppose any steps beyond a voluntary approach.
Center for Food Safety and Applied Nutrition (CFSAN), Office of Cosmetics and
Colors (OCAC) Priorities
The EU delegation was provided a status report on the initiatives being proposed as high
priority for the US cosmetics program. These included various ingredient safety projects,
cosmetic ingredient nomenclature, surveillance and market-place monitoring, enhancing
the Voluntary Cosmetic Registration Program (VCRP), consumer and industry assistance
and international harmonization.
Safety Substantiation
FDA noted that a review of the SCCNFP guidelines for substantiation of the safety of
ingredients had been completed and that written comments would be provided. The EU
delegates said that the SCCNFP is aware of the review and welcomes the comments from
FDA. These comments would then be shared with the other CHIC partners.
Harmonization in Latin America
The EU delegate provided a status report on harmonization efforts in Latin America. It
was reported that a meeting of Latin American authorities was scheduled for mid-November in Chile. It was further reported that the EU planned to sponsor a training
session on implementation of the EU in-market control system to assist the Latin
American authorities in making the transition.
The US representatives expressed concern that the Latin American authorities be aware that the EU
cosmetics definition could not stand alone without an effective product information
package (dossier) system. The US delegates noted that the meeting in August in
Venezuela addressed the adoption of the EU cosmetics definition but did not include
discussion of the accompanying safety and efficacy requirements in the EU. The EU
delegates noted that this had been pointed out to the Latin American authorities in several previous
meetings and expressed the belief that the shift to an in-market system would offer a
substantial improvement over the current licensing systems prevalent in Latin America.
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