IFRA Newsletter No 19 Oct 2010

Transcription

NEWSLETTER No 19
October 2010
Published by IFRA
Editor: Stephen Weller
Email: [email protected]
Website: www.ifraorg.org
FOCUS
recent events
Fragrance in our lives: A choice worth making?
The second speaker was
Association France-Ameriques, Paris, France,
Professor Thomas Diepgen
9 September 2010
from the University Hospital in
th
Jean-Pierre Houri, the IFRA
Heidelberg. His talk focused
President
the
on allergens in the general
70
population, the current data
introduced
proceedings
delegates.
to
The
over
Seminar
available and data that he is
was a chance to explore the
working on through the Eden
different aspects of modern
Epidemiological Study. He
fragrance use. The speakers
outlined some preliminary
in the first session focused on
results from a pilot study
subjects such as the effects of
of the Eden Epidemiological Study, whose full results should
certain fragrance materials
be available in early 2011. The pilot study results showed a
on our physiology and how
reaction in the general population of approximately 0.65%,
to measure it, fragrance allergens in the general population
which is much lower that previous studies have shown using
and what life can be like without a sense of smell and how the
patients in clinics.
condition of anosmia can affect people.
The final speaker of the first session was Professor Thomas
Professor Tim Jacob, from
Hummel from the University of Dresden Medical School.
Cardiff University’s School
Professor Hummel is a leading authority on the condition of
of
gave
the
anosmia, the loss of the sense of smell. He outlined that the sense
on
the
of smell is integral to our ability to relate to our other senses.
secondary benefits of odours.
They are all linked. He
He talked about his recent
explained that people who
research into the beneficial
lose their sense of smell
effects
and
become depressed, their diet
vanillin can have and how
can be affected by either
they can be measured. He
over eating or not eating
said that simply looking at
enough and their sex drive
essential oils was not adequate and that in order to assess the
lessens, mainly due to the
huge potential benefits of odours it is necessary to look at single
depression.
first
Biosciences,
presentation
that
linalool
ingredients and how they interact with us.
IFRA Newsletter - Issue 19 - October 2010 –
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NEWSLETTER - O c t o b e r 2 0 1 0
Roughly 5% of the population will suffer from total smell loss
exciting the senses, triggering emotions, stimulating thoughts
and 20% will suffer from reduced loss. Almost everyone suffers
why isn’t perfumery classified as an art form? She explained
some loss as they get older. However, training can improve
that it mixes a personal vision and technical know-how like
our ability to smell by increasing the amount of receptors and
many other art forms.
expanding the olfactory bulb.
Laurence finished with the thought that the future will involve many
Session Two: The Perfumer’s View
more people living in more mega-cities around the world and
The second session was a chance to hear from the professionals
therefore the need to manage the smells in our daily lives in such
who take the knowledge from the scientific world of olfactory
artificial environments will become increasingly more important.
science and apply it in their professions as perfumers, responsible
for enriching everyday products with the scents we adore.
Panel Debate
Following the presentations
The first speaker was Allan
the
McRitchie, a former perfumer
in an open question and
for household products at
answer session with the
Procter and Gamble. Accord-
delegates. One question
ing to consumer research,
asked about the ability
explained Allan, the perfume
to identify happiness or
can really delight consumers
other effects in the brain
speakers
took
part
and has a big effect on the
created through scents. Professor Hummel explained that we
decision to purchase a product, especially in laundry products
can measure certain effects of scents on our physiology and
where it is a fundamental and multifunctional ingredient.
ask questions, but was not sure the results could be defined
as happiness per se. Professor Jacob suggested that specific
The fragrance, considering how small a component it is in
reactions can be seen, which do suggest benefits in terms of
a household product in terms of volume, is a very important
mood and that techniques were developing all the time to
element in the product’s ability to please and perform.
improve this area of research.
The
was
Another questioner asked about the effects of scents on pregnant
Laurence Fanuel, a perfumer
final
women in particular and if they are different to other women.
and
with
Professor Hummel explained that there was no evidence for
International,
this but that it would be interesting to research. However, it is
based in Paris. Laurence
difficult because pregnant women cannot be subjected to the
spoke about the connection
necessary tests such as MRI scans.
senior
Takasago
speaker
scientist
of the senses and the more
we can experience with all
The perfumers were asked the importance of the fragrance
our senses the more reality we will experience. She explained
formula to them and their profession and what would be
the strong links to emotions and memories that smells have and
the consequences of having to disclose the complete formula
the ability to bring to mind positive past experiences and feelings
for each fragrance. Allan McRitchie explained that it would
with a fragrance.
cause problems because a fragrance formula cannot be
patented and is difficult to copyright and so keeping it a
Laurence talked about the role of fragrance creation as an
trade secret is the only viable option at present to protect the
art form. If art can be defined as a combination of elements
perfumer’s intellectual property.
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To see a video of the event, the presenters’ slides and a
IFRA
full report please go to the IFRA website home page at
Amsterdam, Holland, 27 to 28 September 2010
www.ifraorg.org
A review of the RIFM testing program supporting the
Environmental
Task
th
Force
(ETF)
meeting,
th
development of IFRA Environmental Standards and a discussion
of a forward looking strategy for RIFM’s environmental
program were significant discussions at the meeting.
European Society for Contact Dermatitis (ESCD GERDA) Congress, Strasbourg, France, 15 to 18
The strategy includes proposals for advancing risk and hazard
September 2010
assessment of fragrance materials, a proposed project on risk
The 10th congress of the European Society of Contact Dermatitis
assessment scenarios for developing and emerging markets,
(ESCD) took place in partnership with the meeting of the French
and a consultancy project on the life cycle assessment of
GERDA group (Group d’Etude et de Recherche en Dermato-
fragrance compounding.
th
th
Allergologie). Since its foundation in 1988 the ESCD has been
organizing congresses every two years in different European
countries where clinicians and scientists involved in the field of
IFRA Scientific Committee (SC) meeting, Amsterdam,
allergic contact dermatitis share and discuss the latest clinical
Holland, 29th to 30th September 2010
and research developments.
The IFRA SC held the third of its three two-day meetings for
2010 in Amsterdam. The agenda covered numerous scientific
Since fragrance allergy remains an important topic for
and regulatory issues.
European dermatologists the fragrance industry has attended
and actively participated in this event over the last few
Following a discussion at the June meeting (see IFRA Newsletter
years. This year, as well as representatives of IFRA member
18), the Perfumery Panel was implemented and has already
companies, Anne Marie Api, RIFM Vice President for Human
started to review fragrance ingredients currently studied by
Health, Ladd Smith, RIFM President and Matthias Vey, Scientific
the SC. The contribution of this group will certainly have a
Director of IFRA, attended the meeting. Matthias Vey also
strong and positive impact on the development of future IFRA
presented a poster on the development of Standards over time
Standards.
using the example of 3 and 4-(4-Hydroxy-4-methylpentyl)-3cyclohexene-1-carboxaldehyde (trade name Lyral), one of the
A guest speaker from CITES (Convention on International
fragrance materials that received a lot of attention from the
Trade in Endangered Species of wild Fauna and Flora)
dermatological community and that became part of Fragrance
gave a comprehensive talk to the SC members outlining the
Mix II, an additional tool for the dermatologists to screen for
CITES organization and its objectives. CITES is focused on
fragrance allergy.
the protection of animals and plants via the development of
strict trade regulations. Some species commonly used by the
The actual ESCD meeting was preceded by a one-day Pre-
fragrance industry have recently been added to the CITES
Symposium titled ‘Prevention of Skin Allergy in Europe - a need
annexes (for details see regulatory developments section) and
for a breakthrough.’ Besides hair dyes and metals, fragrance
it was therefore important for the SC to understand the system
ingredients were the subject of the majority of the presentations.
and how to ensure that the CITES rules and their national
Key items related to fragrances were trends of fragrance
implementation do not unnecessarily adversely affect the
allergy, epidemiology, and risk management measures for
fragrance industry’s business. The IFRA Secretariat is about
identified skin allergens.
to join CITES as an observer member and as a consequence
should be in a better position to actively take part in the
decision-making process under the CITES Convention.
3
At the European level, the deadlines for the Classification,
to Beauty. 75 conferences conducted by nearly 150 experts
Labelling and Packaging (CLP) and REACH registration are
interspersed the event.
coming close. A presentation outlining the fragrance industry’s
progress was given by Cristina Arregui, the IFRA Director
For more details click here: Beyond Beauty website.
of Global Chemical Legislation. She stated that in general
the fragrance industry is well prepared and confident in its
capability to register materials in time.
Cosmetics Leaders Asia 2010, Hotel Pullman, Shanghai
Skyway, Shanghai, China, 28th to 29th September 2010
Global warming, mass pollution, a possible mistrust of new
Jean-Pierre Houri, IFRA President, gave the keynote opening
technologies and various other threats impacting the environment
speech and chaired the first session of the event. Houri outlined
have led society to be increasingly committed to the protection of
the role of IFRA and the IFRA Global Safety Program including
nature. Over and above short-term marketing choices, citizens
details of the IFRA Code of Practice, the IFRA Standards, the
consider this change in their daily behavior as a necessity based
Compliance Program and the role of RIFM (Research Institute
on the long-term prospects for their and the planet’s future.
for Fragrance Materials).
In this context IFRA assisted by a dedicated Task Force has
developed an IFRA Guidance to ‘Green’ Fragrance Terminology.
The conference was attended by over 200 delegates from
This document provides a common understanding of the basic
some of the world’s leading brands such as Unilever, Procter &
concepts and terminology used in this field with regard to
Gamble, Shiseido and Coty as well as senior regulators from
fragrance ingredients. It will provide valuable guidance to our
the Chinese State Food and Drug Administration.
industry and customers in the future. It was endorsed by the IFRA
Scientific Committee and is now available on the IFRA website.
For more details go to: www.cla2010.com
Finally, two new members were voted onto the IFRA Scientific
Committee plus one new corresponding member. The two new
2010 FMA/IFRA North America Fall Workshop &
members are Daniel Grell, Vice President, Corporate Product
Luncheon, Creating Fragrances in an Increasingly
Safety and Regulatory Affairs at Firmenich and Chairman of
Transparent World, Glenpointe Marriott, Teaneck,
the IFRA Europe REACH Task Force and Romano Massara,
New Jersey, USA, 13th October 2010
Regulatory Affairs Manager Fragrance Division at Mane SA
At the annual Fall Workshop and
France. The new corresponding member is Deborah Nickels,
Luncheon the Fragrance Materials
Senior Manager for North America and Latin America,
Association announced its strategic
Fragrance Compliance at IFF.
realignment with the International
Fragrance Association (IFRA) to
become IFRA North America. The event also marked the
Beyond Beauty, Paris, France, 15th to 17th September 2010
launch of the new website, www.ifrana.org, which contains
19 500 visitors, or an increase of 2% including 37% of foreigners
in-depth information about the fragrance industry and safety.
attended the 8 edition of Beyond Beauty Paris, confirming its
“IFRA North America has a strong 83-year history as the
international flavor. 530 exhibitors, 5% more than in 2009,
leading fragrance materials association in North America,“
including 47% new arrivals and 39% foreign brands, were
said Jennifer Abril, Executive Director. “Our new expanded global
divided into three exhibitions dedicated to brands, suppliers
reach will serve not only our members, but also the public as we
and the Spa. 3,500 delegates were able to attend the most
ensure the safety of fragrance ingredients and products through
extensive international programme of conferences devoted
industry-wide compliance with the IFRA Code of Practice.”
th
4
The name change reflects the growing need of members to leverage
authority – The Research Institute for Fragrance Materials
global resources to strengthen their voice in North America.
(RIFM), which has been conducting scientific research and
developing safety profiles for fragrance materials and their
About IFRA North America
uses for more than 40 years.
IFRA North America represents the fragrance materials industry
By combining the art and science of making fragrances IFRA
in the United States and Canada. IFRA North America member
North America members bring to the world a universe of
companies create and manufacture perfumes and fragrances for
products enjoyed safely by millions every day.
personal care, home care, and home design products. Companies
that supply fragrance ingredients, such as essential oils and other
raw materials, are also IFRA North America members.
Sustainable Cosmetics Summit, Paris, France, 18th to
20th October 2010
IFRA North America advocates on behalf of the global
A series of in-depth technical programmes and workshops
fragrance industry. They interact with legislative and regulatory
highlighted some of the most pressing issues concerning the
bodies and other stakeholders in the US and Canada and –
production of greener cosmetic products. The three-day event
through their affiliation with IFRA Global – worldwide.
included two days of presentations divided into four segments,
which were given on the first two days. Two workshops were
The primary focus of the fragrance industry is to ensure the safety
given on the last day, October 20. Stephen Weller, IFRA’s
of fragrance ingredients and the industry’s products. That is why
Director of Communications, gave a presentation on definitions
IFRA North America’s member companies are strongly committed
of ‘Green’ in the fragrance industry.
to the IFRA Code of Practice – the highest safety and environmental
standards for fragrance manufacturing and fragrance ingredients.
For full program details go to:
www.sustainablecosmeticssummit.com
In addition, IFRA North America’s work on behalf of its members
is closely coordinated with the fragrance industry’s scientific
Agenda
dates not to be missed
In-Cosmetics Asia, Bangkok,
For more program details and to register
and Keith Grime, President of JKG
Thailand, 2nd to 4th November
visit: www.in-cosmeticsasia.com
Consulting.
For
the
full
program
and to register go to: http://www.
2010
Up to 200 exhibitors are likely to
Cleaning Products Hotel Monaco
line up at In-Cosmetics Asia 2010 in
Alexandria Alexandria, VA, USA,
Bangkok in November, a 50% increase
3rd to 5th November 2010
on 2009. Thai cosmetic manufacturers
This year’s conference will be chaired
import an estimated 90% of their
by Brian Sansoni, Vice President of
ingredients attracting interest from many
Communication and Membership
international ingredient suppliers.
for the American Cleaning Institute
cleaningproductsconference.com
5
Olfaction and Issues: Modulation
RIFM 45th Annual Meeting
Cosmetic Valley, Parfums
of Physiological Responses, Paris,
Highlawn Pavilion, Eagle Rock,
& Cosmétiques - Enjeux
France, November 4 to 5 2010
West, Orange, New Jersey, USA,
Réglementaires, Chartres, France,
The aim of this congress is to debate a
November 12 2010
16th to 17th November 2010
complex and relatively unknown subject
Come to RIFM’s 45th Annual Meeting
Daniel Grell, Vice President, Corporate
and consider possible applications in
and hear about the latest scientific and
Product Safety and Regulatory Affairs
cosmetic,
food
regulatory issues facing the fragrance
at Firmenich and Chairman of the IFRA
industries as well as discuss the latest
industry and listen to featured speakers
Europe REACH Task Force, will be giving
breakthroughs.
including:
a presentation on behalf of IFRA at
• Mark Rossi, PhD., Research Director,
Cosmetic Valley. He will be updating the
th
pharmaceutical
th
and
The congress will have several sessions:
Session 1: Recent Advances on Olfaction
Session 2: Olfaction: Science & Food
Application
Session 3: Olfaction & Applications in
th
Clean Production Action;
• Les Smith, Vice Pres., Research & Dev.,
Coty, Inc.;
audience on details of the recent IFRA
45th Amendment to its Code of Practice
and recent developments concerning
• Paul Seifert, Assoc. Dean, John Hopkins
REACH.
Bloomberg School of Public Health.
Pharmaceutical Industry
For details go to: http://www.congres-
Session 4: Olfaction & Applications in
Attendance fee for members is $79 and
parfumscosmetiques.com/programme-
Cosmetic Industry
for non-members $159. To register go to
des-conferences
the RIFM website: www.rifm.org
Two workshops will also be organized
during the two days. IFRA is a sponsor
of the event.
For more information go to:
www.olfaction-site.com
R e g u l at or y D e v e l o p m e n t s
Existing Chemical Substance Nomination in Taiwan
regulation is to compile an inventory of existing substances
Taiwan’s Council of Labour Affairs announced in April 2009
that have been manufactured in or imported into Taiwan.
the commencement of both an Existing Chemical Substance
Substances in this inventory will not be subject to fulfil the
Nomination (ECN) and a New Chemical Notification (NCN)
requirements established in the NCN scheme (Ref: IFRA IL881).
programme. IFRA issued an Information Letter (IL 854)
accordingly.
Indonesia implements the Globally Harmonized
System (GHS) of Classification and Labeling
The ECN period is now underway, closing on December 2010,
The new regulation (N°87/M-IND/PER/9/2009) promulgated
allowing domestic and non-domestic manufacturers/importers
by the Indonesian Ministry of Industry on September 24th, 2009
to nominate substances using on-line tools. The NCN process
to implement the GHS of Classification and Labeling in Indonesia
is anticipated to start on July 1st, 2011. The intent of the ECN
has entered into force on March 23rd, 2010, six months after
6
its promulgation as predicted in the legislation. Consequently
regarding Aniba Rosaeodora and Bulnesia Sarmientoi which
and from now on, each producer who manufactures chemical
is currently undergoing review by the member countries, and
substances or mixtures of chemical substances and each
should be published within the coming months. It is important to
company that re-packs chemical substances are required to fulfil
note that it is up to the national government authorities on how
the obligations introduced by this legislation on classification,
to deal with these guidelines. It should also be noted that the
labeling and communication issues according to the UN GHS
final position of CITES may evolve further following validation
(Ref: IFRA IL875).
with their members.
IFRA regards extracts as an umbrella term including derivatives
Revision of regulations of New Chemical Substances
such as essential oils, oleoresins or any other type of distillation/
in China
extraction from the source material. All of those fall under the
The revised Chinese Measures on Environmental Management
scope of the requirement of a CITES import/export certificate.
of New Chemical Substances (decree n° 7) were officially
This interpretation is in full compliance with the one of the
issued on January 19 , 2010 by the Chinese Ministry of
European Federation of Essential oils (E.F.E.O).
th
Environmental protection (MEP) and became effective as of
October 15th, 2010 (Chapter Six, Article 52). The original
IFRA learned from CITES that the details of the annotations are
Measures issued by the former SEPA on September 12th, 2003
not yet perfectly harmonized. However the common rule is that,
were simultaneously repealed.
when an annotation is indicated for plants, everything (e.g:
The amended Measures introduce:
product, part of plant or extracts) that falls under the scope of
• more realistic testing based on volume
the convention is outlined in the annotations. Regarding the
• less resource-intensive simplified notification schemes
exemptions, the principle is that anything that is not mentioned
• first signs of exposure-based waiving – risk assessment etc
is exempt. As a consequence:
(Ref: IFRA IL876).
• Finished products are excluded from the scope for both
entries. An explicit mention of exclusion of finished products
for Bulnesia Sarmientoi is not needed;
CITES – Guaiacwood and Rosewood update
• This principle of exclusion can also be extended to fragrance
The IFRA Information Letter 865 explained changes to the CITES
compounds because this would not add an additional
convention (Convention on International Trade in Endangered
level of protection of the plant but only be an additional
Species of wild Fauna and Flora) regarding Bulnesia sarmientoi
administrative burden.
(Guaiacwood) and Aniba rosaeodora (Rosewood), which are
both now listed in Appendix II.
Finally the chemically derived materials were discussed. As
these are produced starting from the essential oils (or from
Those listings in Appendix II triggered a number of questions
other extracts) the starting material is already under the scope
regarding the scope of the CITES measures and the resulting
of the Appendix II, hence requires import/export certificates.
certificate requirements, especially with regards to fragrance
So again there would be no need to have the resulting
compounds.
materials, which are new fragrance/flavor ingredients and
described by different names and CAS numbers, fall under
Following meetings with IFRA representatives the CITES
CITES requirements ie. under the certification procedure (Ref:
Secretariat prepared a draft guidance document (designated
IFRA IL879).
as “notifications to the parties”) on the implementation of CITES
7
New Amendment to the Japanese Chemical
conventions in particular to Principle 15 of the Rio Declaration
Substance Control Law (CSCL)
on Environment and Development by 2020. Although there
A new amendment to the CSCL has been promulgated by the
is currently no official translation of the amended law, a
Japanese Ministry of Economy, Trade and Industry (METI) on
comprehensive presentation has been issued in English by the
May 20th, 2009. This update came into force on April 1st, 2010
Japanese Government and is available via the following link:
and seeks to enhance the public safety through minimizing
http://www.meti.go.jp/policy/chemical_management/
potential adverse effects of chemical substances on human
english/files/CSCL_English.pdf
health / environment but also to comply with international
N ort h A m e rica R e g u l at or y D e v e l o p m e n t s
US Chemicals Management Legislation
enactment, as was proposed in the draft legislation.
In July Representatives Waxman (D-CA) and Rush (D-IL)
• CBI – The section on Confidential Business Information
introduced their TSCA reform legislation, HR 5820 - “The Toxic
(CBI) now attempts to codify EPA’s earlier announcements
Chemicals Safety Act of 2010”.
regarding restricting claims of confidentiality. This section
limits CBI claims to five years, but allows for renewal. EPA
IFRA North America has noted some significant changes from
would also be given discretion to assess fees. EPA will be
the draft legislation introduced several months ago. Highlights
required to publish guidance establishing an acceptable
include:
base for claiming confidentiality.
• Mixtures – IFRA North America was previously most
• Import of Materials – The bill has set out new rules on
concerned about the proposed requirement for declaring
imported materials. Imported chemical substances or
all mixtures to the EPA. The new bill has removed the
mixtures intended for sale would receive equal treatment
most troubling aspects of this provision. However, the EPA
as domestically produced substances (i.e., would impose
Administrator may require mixtures to be reported if deemed
testing requirements, safety standards, reporting and record
necessary.
retention, among others).
• Exemptions – Exemptions for dual-use materials have been
• Pre-emption – The bill gives broad authority to the states
eliminated. Fragrance ingredients previously regulated
as long as state regulations do not impede the scope of the
under another agency (e.g. FDA) would now be captured
federal law.
under TSCA, if the material has a multiple use.
• Priority Chemicals List – The bill includes an Initial Priority
List of 19 named chemicals which would undergo immediate
(DTSC) Safer Consumer Product Alternatives –
review. This list no longer contains musk xylene. It does
Proposed Regulations
contain seven phthalates, but excludes DEP. The list appears
The California Department of Toxic Substances Control (DTSC)
to closely resemble those chemicals on which the EPA has
has issued proposed Safer Consumer Product Alternatives
previously published Action Plans. The bill calls for this
Regulations under the Green Chemistry Initiative.
initial list of 19 to be expanded to 300 within 12 months of
8
Prioritization Process
Confidential Business Information
In the Chemical Prioritization Process section, the prioritization
Lastly, the proposed regulations contain a section on
factors that DTSC may use to place chemicals on the Priority
Confidentiality of Information (p.86). While the proposal allows
Chemicals list are outlined. Among the 26+ factors, listed on
for claims of trade secret status, a manufacturer must provide
pages 31-35 of the proposed regulations, are adverse public
upfront substantiation, as well as a non-redacted copy of the
health impacts that may result from single, intermittent or
information. If DTSC determines that a claim is unsubstantiated,
frequent use or contact with a chemical, including dermal, oral
it would immediately make the information public.
and inhalation exposures, and a number of listed hazard traits,
IFRA North America is developing fragrance industry-specific
as well as any others that California determines may adversely
comments for submission to DTSC by November 1st.
impact public health. While the proposed regulation allows an
exclusion for any chemicals regulated by other California or
federal agencies for the same potential threat, the same chemical
California Bill Defeated
cannot be excluded if the Department determines that there are
The California ingredient disclosure bill (SB 928) was defeated
any data gaps related to cumulative exposure. The proposed
for the 2010 legislative term. The measure had progressed
regulation also allows DTSC the discretion to determine whether
steadily through the Assembly and came very close to passing
a de minimus exemption is applicable to a particular priority
both houses of the legislature. The support and engagement of
chemical.
IFRA North America members was critical to defeating this Bill.
Products that contain one or more priority chemicals and can be
reasonably expected to be placed into the stream of commerce
Definitions for Common Cultivar & Common Food
in California would be contained on the Priority Product list
Crop Issued
(p.37). Products on this list must provide various data points
The Department of Agriculture (USDA) Animal and Plant Health
(p.43) to DTSC, including all persons involved in the supply chain.
Inspection Service (APHIS) issued a proposed rule to establish
In addition, any person can petition DTSC to include a chemical
definitions for the terms “common cultivar” and “common
or a product in the prioritization process. As proposed, neither
food crop” under the Lacey Act amendments. These proposed
the Priority Chemical nor Priority Product list have a limit to the
definitions do not change current policy but provide clarity.
number of items that they can contain.
As you may recall, The Lacey Act is the United States’ oldest
Alternatives Assessment
wildlife protection statute. Recent amendments including
Once a chemical is determined to be a priority for DTSC, the
The Food, Conservation and Energy Act of 2008 expanded
chemical’s manufacturer would be required to undergo an
protections to a broader range of plants and plant products.
Alternatives Assessment, a process which is outlined in the
As amended and effective May 22nd, 2008, The Lacey Act now
proposed regulations.
The regulation includes requirements
makes it unlawful to import, export, transport, sell, receive,
for qualified in-house assessment entities (p.80) to consist of a
acquire, or purchase in interstate or foreign commerce any
manufacturer, consortium of manufacturers, trade association,
plant, with limited exceptions, taken in violation of Federal, State,
or public-private partnership. A potential assessment entity must
tribal or foreign law that protects plants. Since many fragrance
apply to be a qualified in-house assessor. Once an entity is
ingredients originate from plants and recycled plant content,
approved as an assessor, the entity must apply for renewal of its
clear definitions of “common cultivars” and “common food
status every 5 years.
products” are necessary to insure that fragrance ingredients
are not unnecessarily subject to declaration requirements of the
Lacey Act amendments.
9
On December 8th, 2008, FMA submitted comments outlining the
or products thereof, and including trees from either natural or
potential impact on ingredients used in fragrance formulations
planted forest stands.”
and provided suggested definitions of the key terms “common
APHIS indicates that guidance in the form of a list of examples
cultivars” and “common food products.”
of plant taxa or commodities that qualify for exemption from
the provisions of the Act as common cultivars and common
It appears APHIS has taken FMA’s comments into account in the
food crops will be developed and updated to supplement these
rule by proposing to define the terms as follows:
definitions. The most recent version of Questions and Answers
on The Lacey Act Amendments is linked here.
Common cultivar: A plant (except a tree) that has been
developed through selective breeding or other means for
specific morphological or physiological characteristics; and is
Canada Issues Designation for Methyl Eugenol
a species or hybrid that is cultivated on a commercial scale.
Environment Canada and Health Canada recently issued a
final toxic designation for Methyl Eugenol, which was in the
Common food crop: A plant that has been raised, grown, or
ninth batch of substances assessed through the Canadian
cultivated for human or animal consumption, and is a species
government’s Challenge to Industry program.
or hybrid that is cultivated on a commercial scale.
On September 18th, Methyl Eugenol was added to Schedule
Both definitions would exempt any plant that is listed in
1 of the Canadian Environmental Protection Act after the final
an appendix to the Convention on International Trade in
screening assessment was published in the Canada Gazette,
Endangered Species (CITES) of Wild Fauna and Flora; as
Part 1. In addition, a draft risk management plan was released
an endangered or threatened species under the Endangered
for Methyl Eugenol and is open for public comment until
Species Act; or pursuant to any State law that provides for the
November 17th. The plan would require industrial users of the
conservation of species that are indigenous to the State and
substance to notify the Canadian government of any significant
are threatened with extinction.
new use and a phase-out plan for its use of personal insect
Additionally, APHIS proposes to define “plant” to read “any
repellents containing citronella oil.
wild member of the plant kingdom, including roots, seeds, parts
ReACh
an d C l assificat ion , Lab e l l in g & Pac k a g in g ( C LP )
ECHA issues Chesar update
Chesar
version
1.1
now
allows
U p d at e
New Manual to jointly submit
New ECHA Frequently Asked
Chemical Safety Report
Questions on CLP
companies to create a full Chemical
Registrants who are part of a joint
The European Chemicals Agency (ECHA)
Safety Report. The CSR is created in
submission can decide to submit their
regularly publishes valuable information
text form as well as in exchangeable
Chemical Safety Report (CSR) jointly or
on its website to guide people through
database form. Chesar v1.1 works with
separately. New Manual 19 ‘How to
REACH and CLP requirements. ECHA
the IUCLID 5.2 standalone version. More
jointly submit Chemical Safety Reports’
has issued a new “CLP Frequently Asked
outlines the principles which should be
Question” update.
followed in that event.
Click here: http://echa.europa.
eu/clp/clp_help/clp_faq_
en.asp?fuseaction=home.faq
10
Update on the ECHA Data Sharing
individual REACH and CLP processes
The IUPAC name can be considered as
Web Pages
and act as supporting material for the
confidential and thus not be published in
ECHA’s data sharing web pages have
existing guidance documents, content of
the C&L inventory for the following cases:
been updated. They explain now also
webinars and other informative material
• non-phase in substances,
how companies can contact ECHA when
produced by the Agency. More
• substances only used as one or more of
data on vertebrate animal studies are
the following:
not shared in a SIEF, before or after
o as intermediates
the submission of the joint registration
ECHA withdraws Practical Guide 11
o in scientific research and development
dossier. There is a new web form
ECHA has withdrawn Practical Guide
o in
available to notify this type of data
11: How to address specific substance
sharing dispute to ECHA. More
identification
issues:
evaluation
product
and
process-oriented
research and development.
of
different crystalline forms. This decision
For more details click the following link:
is based on feedback that parts of it
http://echa.europa.eu/doc/press/
How to Make Valid Confidentiality
were open to misinterpretation and had
na_10_45_confidentiality_claims_
Claims
caused confusion. More
CLP_20100813.pdf
Confidentiality Claim Justifications under
New version of the IUCLID 5
Calculate your REACH fees -
REACH is now available. More
Technical Completeness Check
IUCLID plug-in available
plugin is available
The Fee Calculation plug-in is for
Many Business Rules are now added
registrants to calculate, in advance, the
ECHA encourages SME registrants
to the Technical Completeness Check
fee payable on the successful submission
to verify their company size
(TCC) plug-in supporting submission of
of their REACH dossier to ECHA.
Companies and Only Representatives
registrations. Inquiry and CLP notifications
The plug-in therefore gives advance
(OR) are encouraged to re-examine
are now also included in the tool. More
information of the likely costs. However,
A New Manual – How to Make
Confidentiality Claims and Write
the company size they have declared
registrants should wait for ECHA to
in REACH-IT at the submission of their
issue an invoice before making their
dossiers. ECHA is checking the cases
ECHA publishes Guidance Fact
payment. The plug-in goes through the
of companies identifying themselves
Sheet on Use Descriptor System
IUCLID 5 dossier to create a list of fees
as micro, small- or medium-sized.
This Guidance Fact Sheet provides a short
in accordance with the Fee Regulation
Companies may be asked by ECHA to
summary of the key aspects of the REACH
for REACH (Regulation EC/340/2008).
prove their SME status and if they fail
use descriptor system to standardize the de-
It works for both REACH registration
to do so, they will be charged the full
scription of the uses of the substances. More
and PPORD notification dossiers and
is also able to calculate the costs of
REACH fee or the fee applicable to their
revised size. More
Confidentiality of IUPAC names in
confidentiality claims.
the C&L Inventory
Companies not registering by the 2010
Please click the following link for more
New translations of Practical
registration deadline but who are never-
information and to access the tool: http://
Guides are available in 22
theless obliged to notify the Classification
echa.europa.eu/news/na/201009/
languages
and Labelling of substances to ECHA as
na_20100921_en.asp
The Practical Guides provide further
of 3rd January 2011 can, in certain cas-
information on best practices concerning
es, keep the IUPAC name confidential.
12
The REACH Committee agrees
has two years’ transitional period, i.e.,
criteria for PBT and vPvB’s and
companies having registered substances
• Impossibility of transferring pre-registra-
authorization list
according to the “old” criteria have 2 years
tions or submitting a late pre-registration
The REACH Committee has agreed at the
to update their existing registration dossiers.
due to legal entity changes (Issue No. 15).
last meeting on two issues:
Both Annexes must now go to the European
• Failure by the lead registrant to submit a fully
• Criteria for identifying PBT and vPvB
Parliament for its three-month scrutiny
REACH compliant dossier (Issue No. 20).
according to the new comitology procedure
• Downstream users are obliged to
• First authorisation list (REACH Annex XIV)
and are likely to be published in the EU
become importers, as a substance
As expected, the REACH Committee
Official Journal in the first quarter of 2011.
is not registered by any EU based
substances (REACH Annex XIII)
from their suppliers (Issue No. 10).
supplier (Issue No. 21).
adopted ECHA’s recommendation (list
• Registrants need to accommodate
of prioritised substances for addition
to Annex XIV): (http://echa.europa.
ECHA offers support to registrants
new/updated guidance and hence
eu/doc/press/pr_09_07_annex_xiv_
in exceptional cases
have difficulties to provide data in
rec_20090602.pdf) with the exception of
Companies facing exceptional situations that
Annex VII and Annex VIII in due time
short-chain chlorinated paraffins (SCCPs).
are likely to prevent them from registering
(Issue No. 10).
The six substances subject to authorisation are:
on time should inform ECHA well ahead of
• 5 -tert-butyl-2,4,6-trinitro-m-xylene
the deadline of 30th November 2010.
Please click here for more details.
(musk xylene)
• 4,4’ – diaminodiphenylmethane (MDA)
In five specific scenarios, the Directors’
• Hexabromocyclododecane
Contact Group (DCG) has agreed that
(HBCDD)
(and all major diastereoisomers)
ECHA can offer help either by relying on
• Bis(2-ethylhexyl)phthalate (DEHP)
its discretionary rights under REACH or
• Benzyl butyl phthalate (BBP)
by providing companies a transparent
• Dibutyl phthalate (DBP)
means to demonstrate good faith. Every
People
on t h e Mo v e
affected company will need to submit a
Each substance has a date by which
web-form as far ahead of the deadline as
companies seeking authorisations have
possible, providing detailed justification
to submit their applications, and a sunset
of its situation and an explanation of
date after which manufacture and use
the measures that it has taken to comply
will be prohibited.
Musk xylene has
with its obligations under REACH. Upon
New Director of Communications
been prohibited for use in fragrance
receiving this information, ECHA will
for IFRA North America
compounds in the 44 Amendment to the
provide instructions as to how to submit
Elena
IFRA Code of Practice.
a registration by the deadline.
North America as the Director of
th
Solovyov
has
joined
IFRA
Communications. Elena has provided
In regards Annex XIII (criteria for
identification of PBTs and vPvBs) the
The DCG has identified the following
communications counsel to FMA and
agreed text is based on the European
instances where such pressing and
many individual member companies
Commission’s proposal introducing the
exceptional circumstances could apply:
in the past, when she managed the
possibility of a
“weight of evidence”
• Difficulties to provide data required in
Cosmetics and Fragrances Practice at
approach when assessing substance
Annex VII and Annex VIII in due time
Dezenhall Resources in Washington DC.
properties. It was decided that authorities
or difficulties for importers of mixtures
Elena is very experienced and knows the
can use the weight of evidence approach
to obtain compositional and analytical
fragrance industry and the issues well.
once the text becomes legal, but industry
data of the substances in the mixture
13
MED I A
articles published
IFRA Event Asks: Fragrance in Our Lives -
Fragrance Research Institute
A Choice Worth Making?
goes for broader audience
The International Fragrance Association will hold a seminar,
The Research Institute for Fragrance Materials (RIFM) is trying to
“Fragrance in Our Lives – A Choice Worth Making?” on
move further into the public eye in the hope it can help counteract
September 9 at L’Association France-Ameriques in Paris. The
some of the ‘erroneous’ claims about the industry in the press.
event will include talks from Tim Jacob (School of Biosciences,
The RIFM is an international scientific authority that performs
Cardiff University) on the psychophysiological responses to
safety assessments on fragrance raw materials found in personal
pleasant and unpleasant smells, Thomas Hummel (Smell &
care and household care products.
Taste Clinic, Department of Otorhinolaryngology, University of
An independent expert panel, including dermatologists,
Dresden Medical School) on anosmia and its effects, perfumer
toxicologists and environmental scientists, reviews all RIFM data
Allan McRitchie on fragrance in the marketing mix, and more.’
and the resulting reports and summaries are published in both
Perfumer & Flavorist - 28 July, 2010
peer-reviewed scientific journals and on the RIFM’s website.
http://www.perfumerflavorist.com/events
Cosmetics Design - 13th Sept, 2010
th
coverage/99458809.html
IFRA seminar focuses on how fragrance
Personal Care Magazine
can enhance well-being
The International Fragrance Association (IFRA) will be holding a
The IFRA seminar, held last week in Paris, chose to focus on how
symposium in September that will aim to showcase the latest in
fragrance can be used to tap into a sense of well-being through
fragrance research.
positive associations.
Titled “Fragrance in our lives – a choice worth making?”, the
The seminar, held at L’Association France-Amerique on September
half-day symposium will be held on 9 September 2010 in Paris
9, focused on scientific and formulation issues such as the
at L’Association France-Ameriques. The presentations will feature
perception of fragrance and its effects on the physiology, while
viewpoints on the psychological responses made to a range of
the second part focused on the creative process.
fragrances, the effect of anosmia and allergies, as well as the
Cosmetics Design - 15th Sept, 2010
benefits of fragrances to everyday life.
http://www.cosmeticsdesign-europe.com/Formulation-
Personal Care Magazine - September 2010
Science/IFRA-seminar-focuses-on-how-fragrance-can-
http://www.personalcaremagazine.com/Story.
enhance-well-being/?c=OcFIO33tG9ypgICfV8GSEA%3D%3
aspx?Story=7213
D&utm_source=newsletter_daily&utm_medium=email&utm_
campaign=Newsletter%2BDaily
BBC Radio 4 – You and Yours
Jean-Pierre Houri was interviewed for a segment on fragrance
creation and the IFRA Global Safety Program.
Ils ont dit…
BBC Radio 4 - 3
A l’occasion du séminaire de l’IFRA sur le parfum, Tim Jacob,
rd
Sept, 2010
professeur a l’université de Cardiff (Biosciences): «Les huiles
essentielles ont de nombreux modes d’action, très spécifiques, et
leurs effets bénéfiques sont potentiellement énormes”.
Cosmétique Hebdo No. 465 - 20th Sept, 2010
Disclaimer: The information contained in this newsletter is provided by “The International Fragrance Association” and whilst we
endeavour to ensure the information is up-to-date and correct, we make no representations or warranties of any kind, express or
implied, about the completeness, accuracy, reliability, suitability or availability with respect to the newsletter or the information, products,
services, or related graphics contained therein for any purpose. Any reliance you place on such information is therefore strictly at your own risk.
Through this newsletter you are able to link to other websites which are not under the control of “The International Fragrance Association”. We have no
control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views
expressed within them.
14

IFRA Newsletter No 19 Oct 2010

Transcription

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