Impact of cosmetics regulation changes - webinar, 19 December 2012, 2pm GMT - Chemical Watch
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Impact of cosmetics
regulation changes
webinar, 19 December 2012, 2pm GMT
Today’s webinar - aims To highlight the key issues that companies need to focus on, looking at notification, roles and responsibilities; To delve deeper into cosmetic product safety assessments, including exposure calculations and toxicological profiles; and To tackle the reporting of serious undesirable effects, providing case studies to further illustrate the discussion.
Q&A session
If you have any unanswered
questions please submit
them to the Chemical Watch
Forum, after the webinar.
http://forum.chemicalwatch.com
Speakers Dr Emma Meredith, Head of Scientific and Technical Services, The Cosmetics, Toiletry and Perfumery Association (CTPA) Camille Bossard, Toxicologist, CEHTRA Dr Gerald Renner, Director Technical Regulatory Affairs, Cosmetics Europe Chair: Emma Chynoweth, Chemical Watch
Chemical Watch Webinar:
Impacts of Recent Changes in Cosmetics Regulation
Roles & Responsibilities
Notification
Nanomaterials
Dr Emma Meredith
Head of Scientific and Technical Services
Cosmetic, Toiletry and Perfumery Association
www.ctpa.org.uk
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.uk
Current Cosmetic Legislation
European Cosmetics Directive (76/768/EEC)
…..as amended
UK Cosmetic Products (Safety) Regulations 2008
(SI No.1284)
…..as amended
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.uk
The (near!) Future……
New European Cosmetics Regulation
(Regulation (EC) No. 1223/2009)
Directly applicable in all 27 Member States
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.uk
New EC Cosmetics Regulation 1223/2009
Published in OJ: L342, 22.12.2009
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF
Implementation: 11 July 2013
Some aspects phase-in before this date
In-market Control
UK Competent Authorities
Implementation:
BIS (Department for Business, Innovation and Skills)
Enforcement:
Trading Standards
Cosmetic Legislation: Safety - no change!
Simply:
Product must be SAFE
This must be demonstrated
Adequate information must be provided to
Competent Authorities and consumer
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.uk
New EC Cosmetics Regulation
Major changes:
Roles and Responsibilities
Notification
CMRs
Safety Assessment/Assessor
Nanomaterials
Claims
Reporting of Serious Undesirable Effects
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNew EC Cosmetics Regulation: Articles
1: Scope and Objective 20: Product Claims
2: Definitions 21: Access to information for the public
3: Safety 22: In-market control
4: Responsible Person 23: Communication of serious undesirable effects
5: Obligations of the responsible person 24: Information on substances
6: Obligations of the distributors 25: Non compliance by the responsible person
7: Identification within the supply chain 26: Non compliance by the distributors
8: Good manufacturing practice 27: Safeguard clause
9: Free movement 28: Good administrative practices
10: Safety assessment 29: Cooperation between competent authorities
11: Product information file 30: Cooperation regarding verification of PI file
12: Sampling and analysis 31: Amendment of the Annexes
13: Notification 32: Committee
14: Restrictions in the Annexes 33: Glossary of common ingredient names
15: CMRs 34: Competent authorities, poison control centres
16: Nanomaterials 35: Annual report on animal testing
17: Traces 36: Formal Objection against Harmonised Standards
18: Animal testing 37-40: Penalties; Repeal; Transitions; Dates
19: Labelling
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukEC Cosmetics Regulation: Annexes
I: Cosmetic Products Safety Report
Preamble to Annexes II to VI
II: List of Substances Prohibited in Cosmetic Products
III: List of Substances which Cosmetic Products Must Not Contain Except Subject to the
Restrictions Laid Down
IV: List of Colorants Allowed in Cosmetic Products
V: List of Preservatives Allowed in Cosmetic Products
VI: List of UV Filters Allowed in Cosmetic Products
VII: Symbols used on packaging/container
VIII: List of Validated Alternative Methods to Animal Testing
IX: Part A - Repealed Directive with its successive amendments
Part B - Lists time-limits for transposition into national law and application
X: Correlation Table
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukPlease note:
There are LOTS of errors in the Annexes to the new
Regulation text, and they are only dated up to 2009
Use the Cosmetics Directive and its Adaptations
until July 2013
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukLayout of Regulation Text - New Chapter Structure
Chapter Title Articles
Recitals
I SCOPE, DEFINITIONS 1-2
II SAFETY, RESPONSIBILITY, FREE MOVEMENT 3-9
III SAFETY ASSESSMENT, PIF, NOTIFICATION 10-13
IV RESTRICTIONS FOR CERTAIN SUBSTANCES 14-17
V ANIMAL TESTING 18
VI CONSUMER INFORMATION 19-21
VII MARKET SURVEILLANCE 22-24
VIII NON-COMPLIANCE, SAFEGUARD CLAUSE 25-28
IX ADMINISTRATIVE COOPERATION 29-30
X IMPLEMENTING MEASURES, FINAL PROVISIONS 31-40
Annex I
Preamble to Annexes II-VI
Annexes II-X
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukRoles/Responsibilities
Mentioned in Requirement
Roles/Responsibilities
Extended
Recitals
Article 2 New
Definitions
Article 3 Extended
Safety
Article 4 Extended
Responsible person Article 5 New
Article 7 New
Article 10 Existing
Article 11 Extended
Article 13 Modified
Article 16 NewRoles/Responsibilities
Mentioned in Requirement
Roles/Responsibilities Article 20 Modified
Article 21 Modified
Responsible Persons Article 23 New
Article 24 New
(cont)
Article 25 New
Articles 4.6 New
Article 7 New
Article 13 New
Distributors New
Article 23
Article 22 Extended
Article 24 New
Articles 25 to 30 New / Extended
Member States
Article 36 NewWho is the Responsible Person?
In most instances: RP will be the manufacturer or importer of
the product
Importer is always RP for the specific imported cosmetic
product they place on the market
Exceptions:
Distributor who places a cosmetic product on EU market under
their name or Trade Mark
Distributor who modifies a product in such a way that
compliance with the applicable requirements may be affected
(not the case if mere translation)
Written mandate from manufacturer or importer to third party
who accepts it in writing
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukRoles/Responsibilities
Some new requirements
Helpful definitions
Can nominate Responsible Person
New responsibilities for distributors
Conformity, traceability and communication
Product recall
Administrative cooperation
Cosmetics Europe Guidelines
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNotification: Article 13
Directive - different in each Member State
Regulation - common electronic notification
Cosmetic Product Notification Portal (CPNP)
Regulation - Poison Centres covered
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNotification
Notification Requirements:
new and existing products /
Product category
Product name(s)
Responsible Person - name and address
Country of origin (import only)
prior to market
Member State where the product is placed on the market
Details of physical person to contact in case of necessity
Nanomaterials – identification and exposure conditions
CMRs (1A & 1B only)
Frame formulation
products
Original labelling (only once)
only
new
Photograph of packaging (only once)
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNotification - CPNP
In order to access the CPNP, the user needs a user login and password.
Two systems are needed:
The European Commission Authentication Service (ECAS)
This system provides the user with a login and password to connect to multiple
Commission applications
The SANCO Authentication and Authorisation System (SAAS)
This system provides the user with a profile and access rights for a specific
Commission application, in this case the CPNP. Within this system the first user
sets up a new organisation. Any subsequent user from that organisation may
request access
The address to register to use the system:
https://webgate.ec.europa.eu/aida/selfreg
The address to access the system:
https://webgate.ec.europa.eu/cpnp
Commission User Manual:
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/cpnp_new_en.pdfWho notifies?
Responsible Person - Article 13(1&2): Prior to placing new
product on the market and for existing products
Distributors - Article 13(3): When distributor translates the
labelling on his own initiative for sale in another Member State
Responsible Person - Article 13(4): When a distributor re-
introduces a product no longer placed on the market by the
responsible person
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNotification: Article 13
Responsible Person now has option to notify new products
under Cosmetics Directive or to use the CPNP
But…..
From 11 July 2013 all products on the market must be notified
via the CPNP
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNanomaterials
Four areas introduced in the Regulation relating to nano:
Definition
Notification
Safety Assessment
Labelling
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNanomaterials
Definition: Article 2, 1 (k)
Nanomaterial” means an insoluble or biopersistant and
intentionally manufactured material with one or more external
dimensions, or an internal structure on the scale from 1 to 100nm
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukRegulatory and Practical Considerations
Conflict of cosmetics Nano definition with EU
overarching definition of nanomaterial
(Recommendation by Commission DG Env)
Main difference : cut-off level for particle size
distributions
Characterisation methods are not available for
routine testing by industry or control authorities
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukWhat will happen in 2013?
Cosmetic companies and authorities:
will have to manage non-harmonised interpretation
will have to fulfill their obligations (compliance and control)
without routine measurement tools being available
Ongoing discussion between Commission, Member States, EU Joint
Research Centre and industry to update the nanomaterial definition
for cosmetics and provide guidance on characterisation methods
Cosmetics Europe has issued a technical information package which
can help companies to technically justify decisions they have taken
in this situation
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNano Notification: Article 16
Additional to general notification scheme (i.e. CPNP)
Notification requirements:
Identification
Specification
Quantity
Toxicological profile
Safety data
SCCS review
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNano Notification: Article 16
Does not apply to:
• Nanomaterials in positive list Annexes
• Nanomaterials in Annex III
However…
Preamble to the Annexes states substances listed in Annexes
do not cover nanomaterials unless specifically mentioned
Dates:
• Products already on market:
between 11 January 2013 – 11 July 2013
• Products new to market:
6 months in advance to comply by 11 July 2013
(from 11 January 2013)
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNano Safety Assessment
Article 16, paragraph 1
“For every product that contains nanomaterials as defined in
Article 2, a high level of protection of human health shall be
ensured”
Annex I - Part A, paragraph 8
“Particular consideration shall be given to any possible impacts
on the toxicological profile due to particle sizes, including
nanomaterials”
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukNano Labelling
Article 19(1)
“All ingredients present in the form of nanomaterials shall be
clearly indicated in the list of ingredients. The names of such
ingredients shall be followed by the word “nano” in brackets”
Applies to all nano-containing products – 11 July 2013
For consumer information only – no relevance to safety
NOT a warning statement
Chemical Watch Webinar: 'Impacts of Recent Changes in Cosmetics Regulation' 19 December 2012
www.ctpa.org.uk www.thefactsabout.co.ukCosmetic product safety
report
Camille Bossard, Pharm.D., M.Sc.
December 19th, 2012Cosmetic product safety report
- Described in the Annex I of Regulation (EC) No 1223/2009
- Divided into 2 different parts:
q PART A –Cosmetic product safety information
Þ Gathering of all the data that will allow to identify and quantify the danger that
may arise from:
- the ingredients contained in the product
- the manufacturing process
- the presence of impurities in the product
- the conditions of use of the product
- etc.
q PART B – Cosmetic product safety assessment
Þ Scientific based risk assessment performed using all the data gathered in
Part A
December 2012 2PART A –Cosmetic product safety information
1.Quantitative and qualitative composition of the cosmetic product
2.Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4.Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product
December 2012 3PART A –Cosmetic product safety information
1.Quantitative and qualitative composition of the cosmetic product
2.Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4.Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product
December 2012 4PART A –Cosmetic product safety information
3. Microbiological quality
- Microbiological specifications of the different raw materials and the cosmetic product
(original level of contamination, possibility of microbial growth)
- Attention should be taken to cosmetics used :
§ in sensitive body parts (i.e., on mucous membranes, around the eyes, on damaged
skin, etc.)
§ on specific populations (i.e., children under 3, elderly people, persons with
compromised immune responses)
- Results of preservation challenge test
Þ Justification of the period after opening of the finished product to ensure its safety
For more details, refer to the « Guidance on Microbiological Quality of the Finished Cosmetic Product » in the
SCCS/1416/11
December 2012 5PART A –Cosmetic product safety information
4.Impurities, traces, information about the packaging material
- Impurities = unintended substances in raw materials
- Traces = small quantity of unintended substances in the finished product
- In case of traces of prohibited substances (i.e., Annex II) => evidence of their technical
unavoidability must be demonstrated (ALARA principle, GMP)
- Relevant characteristics of the packaging material:
§ Purity => identification of potential substances that can migrate from them
§ Stability => identification of potential degradation products that can arise from the
contact with the formulation
=> Assessment of the dangers and the risks related to non intentionally added substances
in the cosmetic formulation
December 2012 6PART A –Cosmetic product safety information
1.Quantitative and qualitative composition of the cosmetic product
2.Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4.Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product
December 2012 7PART A –Cosmetic product safety information
6. Exposure to the cosmetic product
- A good description should be provided and shall
answer the following questions:
§ Is it a leave-on or a rinse-off product?
§ What is the area of application?
§ Which population will use it?
§ Which reasonably and foreseeable routes
of exposure can be considered? (e.g., oral
for lipstick and toothpaste, etc.)
§ Which amount of product will be applied
per application?
§ Duration and frequency of the
application?
§ Is there any impact of the particle size on
exposure?
- Exposure expressed as mg/cm² of skin or mg/kg
bw
December 2012 8PART A –Cosmetic product safety information
7. Exposure to the substances
Determination of the potential systemic exposure to all the substances contained in the
formulation based on the data described in the point 6.
For a cosmetic ingredient CI1 contained at a certain concentration %CI1 in a cosmetic product CP:
ExposureCI1 (mg/kg bw/d) = ExposureCP (mg/kg bw/d) x %CI1
Tables and help in exposure evaluation are provided in the SCCS’s Notes of Guidance SCCS/1416/11
December 2012 9PART A –Cosmetic product safety information
8. Toxicological profile of the substances
Consists in the following steps of the risk assessement process, for each substance present
in the cosmetic product:
§ Hazard identification: based on the results of the different in vitro and in vivo tests
performed on each substances
§ Dose-response assessment: determination of a NOAEL for effects with threshold
§ Exposure assessment (determined in parts 6 and 7)
§ Risk characterization: calculation of a Margin of Safety (MoS) based on the
systemic exposure (SED) and NOAEL for each substance
December 2012 10PART A –Cosmetic product safety information
8. Toxicological profile of the substances
To do so, the following data should be provided for each substances and mixtures present
in the cosmetic product:
§ Acute toxicity (oral, dermal, inhalation)
§ Corrosivity and Irritation
§ Skin sensitization (Type IV)
§ Dermal / percutaneous absorption
§ Repeated dose toxicity (28-d and 90-d RD toxicity study in rodents +++)
§ Mutagenicity / Genotoxicity
§ Carcinogenicity
§ Reproductive toxicity (OECD 414 and 421 +++)
§ Toxicokinetics (TK)
§ Photo-induced toxicity (UV absorption spectra, and if necessary phototoxicity testing)
December 2012 11PART A –Cosmetic product safety information
8. Toxicological profile of the substances
For the different endpoints, data from the following sources can be used :
§ In vitro and in vivo studies performed in accordance with the animal testing
limitations set in the Regulation (EC) No 1223/2009
§ Human data
o Experience in cosmetic products
o Clinical data (compatibility studies, studies conducted under other regulations
such as pharmaceuticals, food, etc.)
o Post-marketing experience data
§ Data on similar compounds (read across)
§ QSAR model output
§ Etc.
Þ Aim: Determine a systemic N(L)OAEL based on the most relevant endpoint, and the
tolerance of the substance
Raw material impurities:
Ø If their presence in the tested batch is justified in a certificate of analysis => no further action will be necessary
Ø If not present in the tested susbtance => data will have to be provided
December 2012 12PART A –Cosmetic product safety information
8. Toxicological profile of the substances
All the other
Substances in
substances of
Annexes II, III, IV,
SAFETY
the cosmetic
V and VI fall SCCS
in DG SANCO ASSESSOR product fall
under the
under the
responsibility of
responsibility of
the SCCP
the safety
assessor
December 2012 13PART A –Cosmetic product safety information
8. Toxicological profile of the substances
After considering all the possible routes of exposure, and the absorption rate of a cosmetic
ingredient CI1, the systemic exposure can be calculated as:
Systemic Exposure Dose (SED)CI1 = External exposureCI1 x AbsorptionCI1
The Margin of Safety (MoS) for a specific route can then be calculated using the following
formula:
MoSCI1 = Systemic NOAELCI1 / SEDCI1
The MoS for each substance should be > 100 for adults and > 1000 for children under 3
December 2012 14PART A –Cosmetic product safety information
9. Undesirable effects and serious undesirable effects
- Filled in after the cosmetic product was put on the market in the EU
- Should be presented as statistical data , whatever the imputability to the product
- Must be kept up-to-date
10. Information on the cosmetic product
Any other information on the product which was not covered in the Part A should be
included here, such as:
§ existing studies from human volunteers
§ the duly confirmed and substantiated findings of risk assessments carried out in
other relevant areas (pharmaceuticals, foods, etc)
December 2012 15PART B – Cosmetic product safety assessment
1. Assessment conclusion
2. Labelled warnings and instructions of use
3. Reasoning
4. Assessor’s credentials and approval of part B
December 2012 16PART B – Cosmetic product safety assessment
1. Assessment conclusion
Statement on the safety of the cosmetic product in relation to Article 3 of Regulation (EC)
No 1223/2009 (i.e., safe or safe with restrictions)
2. Labelled warnings and instructions of use
Statement on the need to label any particular warnings and instructions of use in
accordance with Article 19(1)(d) of Regulation (EC) No 1223/2009.
The safety assessor must determine which warnings or instructions of use, in addition to
those stated into the Annexes III to VI, should be labelled.
For instance, for shower gel that is “slightly irritating to the eyes”, the warning “In the
event of contact with eyes, rinse immediately with plenty of water” can be labelled.
December 2012 17PART B – Cosmetic product safety assessment
3. Reasoning
Reasoning of the safety assessor, explaining how he reaches his conclusions (i.e., whether
the product is safe or not), for both the substances, and the product.
Specific risk assessments should be carried out for products intended for use:
§ on children under 3
§ in external intimate hygiene
4. Assessor’s credentials and approval of part B
This part must contain the following information:
§ Name and address of the safety assessor.
§ Proof of qualification of the safety assessor.
§ Date and signature of the safety assessor.
December 2012 18References
• Regulation (EC) no 1223/2009 of The European Parliament and of The Council of 30 November
2009 on Cosmetic Products
• The SCCS‘s notes of guidance for the testing of cosmetic ingredients and their safety evaluation –
7th Revision (Dec. 2010)
• Safety assessment of personal care products/cosmetics and their ingredients - Gerhard J.
Nohynek, Eric Antignac , Thomas Re, Herve Toutain - Toxicology and Applied Pharmacology 243
(2010) 239–259p
December 2012 19Cosmetovigilance and
Reporting of Serious
Undesirable effects
Gerald Renner
Director Technical Regulatory Affairs
Cosmetics EuropeUndesirable effects to cosmetics • EU Cosmetics Regulation requires products “to be safe” BUT this does not mean “zero risk” • Small proportion of consumers will inevitably experience undesirable effects • Products are still considered safe if the rate / nature of the undesirable effects remain wirhin acceptable limit • Same issue independent of regulatory apporach (pre-market approval or in-marker control)
Undesirable effects to cosmetics
(UE)
UE from normal use of cosmetics are generally :
– local (itching/ burning, irritation, allergic skin
reaction)
– transient
– succesfully addressed by patient self-
management without medical interventionUndesirable effects to cosmetics • Vast majority of cases do not result in medical consultation • Very rarely, more serious effects may occur • Undesirable effects per se do not mean that the products are unsafe. • Concerns arise if the type or frequency of reactions create a safety signal à role of cosmetovigilance is to make such safety signals visible
Objective of Cosmetovigilance Support post marketing surveillance by companies and authorities • Add information to the post marketing safety evaluation a given product • Contribute to the decision making process for risk management Safety Signal Generation : • Detect unexpected changes of reporting rates (number and/or nature of UEs) compared to an existing baseline
EU Approach on Cosmetovigilance Main source of information is industry • Logical and nearest contact point for EU consumers – especially n case of non-serious undesirable effects. • Data can be easily collected on individual products and be compared between similar products • Industry standards can be developed for handling and assessing UEs, thus allowing data to be comparable across the industry Priority is given to serious undesirable effects • Non-serious cases need to be recorded as summary information in the product information file • Serious cases need to be actively reported to the authorities
Cosmetovigilance Elements in the EU
Cosmetics Regulation 1223/2009/EEC
Chapter Title Articles
I Scope, definitions 1-2
II Safety, responsible person, free movement 3-9
III Safety Assessment, product information file, 10 - 13
sampling and analysis, notification
IV Restrictions for certain substances 14 - 17
V Animal testing 18
VI Consumer information 19 - 21
VII Market surveillance 22 - 24
VIII Non-compliance, safeguard clause 25 - 27
IX Administrative cooperation 28 - 30
X Implementing measures, final provisions 31 - 40
ANNEXES I-XIn a nutshell : Who ? Responsible Person (and Distributor) What ? All Serious Undesirable Effects (SUE) cases , except those classified as “excluded” Where ? Country where serious undesirable effect occurred When ? Initial report : Without delay (understood as calendar 20 days) Follow-up report : When new relevant information is obtained How ? Standardised SUE reporting forms, following EU Guidelines
Art. 2 : Definitions
• (o) «Undesirable effect» means an adverse
reaction for human health attributable to the
normal or reasonably foreseeable use of a
cosmetic product Causality assessment !
• (p) «Serious undesirable effect (SUE)» means an
undesirable effect which results in temporary or
permanent functional incapacity, disability,
hospitalization, congenital anomalies, or an
immediate vital risk or death
Note : the word "serious" is not synonymous with severe. "Severe" is used to
describe the intensity (severity) of the effect as in mild, moderate or severe.
Seriousness is used to describe the patient/event outcome or action.• Article 10(1) & Annex I : Information to be
included in the Cosmetic Safety Report
– All available data on the UEs and SUEs to the
cosmetic product, or where relevant, other
cosmetic products
• Article 21: Access to information for the public
– …existing data on UEs and SUEs , attributable
to the productsArticle 23: Communication of SUEs
In the event of SUEs, the responsible person and distributors
shall without delay notify the following to the competent
authority of the Member State where the SUE occurred:
• All SUEs which are known to him or which may
reasonably be expected to be known to him;
• The name of the cosmetic product concerned,
enabling its specific identification
• The corrective measures taken by him, if any
When distributors, end users, Professionals of Health report
serious undesirable effects to the competent Authority (…), this
competent authority shall immediately transmit the information
(….) to the responsible personEuropean Commission Guidance on
reporting of Serious Undesirable Effects
European Commission, with Member States and Industry has
developed guidance and template report forms based on EU Cosmetics
Regulation :
• Causality Assessment method
• Scope of notification of SUEs
• Requirements for notification and transmission of SUEs
• Principles of interaction between the Responsible Person,
Distributor and National Competent Authority
• Subsequent actions by Responsible Person and Competent Authority
Pilot studies with industry are ongoingCausality Assessment
Suspected undesirable event
Is there a causal relationship with the reported product ?
NO YES
Undesirable Undesirable
Event EffectNot always so easy !
Ø Suspected Undesirable Events
ØRarely confirmed by relevant medical investigations
ØOften with consumer interpretation
ØRarely only 1 product used
Ø The case information is often not easily assessed as YES
(Very Likely) or NO (Excluded)
Ø If not easy : need to avoid subjective evaluationDevelopment of a
Causality Assessment
Method with intermediate
levels of relatedness.
This method is included in the EU
Commission Guidelines on SUE
reportingObjective of the method.
Ø Consistent and reproducible analysis/evaluation of
reported cases
ØBetween Companies
ØInside the Company
ØWith all stakeholders (e.g. authorities)
Ø To estimate the degree of relation between the use of a
cosmetic product and the development of an undesirable
effect
Ø For each individual case reportPrinciple of the method.
Ø Analysis of 3 key parameters
Ø Symptoms : Semiology
Ø Time sequence of event(s) : Chronology
Ø Specific medical investigation(s) and/or
Re-exposure to the product: rechallenge
5 levels of causality :
Very Likely - Likely - Not clearly attributable - Unlikely - ExcludedCausality decision table
Symptomatology
Evocative Non evocative
Rechall. / Invest. Rechall. / Invest.
+ ? - + ? -
Chronology
Compatible VL L NCA L NCA UL
Delay
between
exposure Not clearly
and Compatible L NCA UL NCA UL UL
reaction
onset
Incompatible Excl Excl Excl Excl Excl ExclImportant considerations Ø Assessment of individual cases Ø Assessment possible only if enough information is available Ø Assessor must have appropriate background and training in undesirable event assessment Ø Whenever appropriate, support of a medical expert should be sought Ø Assessment can change when new information is collected
CASE 1 - Narrative Phone call from the mother of a 16 years old consumer. Reports that her daughter has had an anaphylactic shock the day before, following the use of a body lotion. Her daughter is still hospitalized in an intensive care unit Serious Case ? Causality ?
CASE 1 - Narrative
Additional contact with mother and family doctor
• Identification of the product,
• Use history : Christmas gift, used intermittently for 2 months, 3 or 4
applications without problem
• Details about the reaction:
– occurred at home at 3 pm, a few minutes after applying the
product on the legs and hands.
– Reported: breathing problem, difficulty speaking, feeling of
sickness. Self-medication corticosteroids without effect.
– Called Hospital Mobile Intensive Care Unit who stated hypotension,
swollen face, abdominal pain.
• Hospitalisation in intensive care unit where she spent the night.CASE 1 - Narrative Additional information continued : Relevant medical history : – Known allergic background, confirmed latex allergy . Food allergies (banana, kiwi, avocado). – Food/ exercise induced allergy. Emergency kit available at home – No previous problem with cosmetic products The mother does not know the treatment given, does not have the report of hospitalization Serious Case ? Causality ?
CASE 1 - Narrative New phone contact with the mother detailing the 2 hours preceding the reaction : • Regular meals between 1 and 2 pm • Between 2: 00 pm and 3: 30 p.m. fitness, ate some chocolate • Application of the body lotion on the hands and legs at about 3: 30 p.m. • 3: 30 pm manipulated a latex balloon, • 3: 43 itching hands, then breathing problem, eyes pruritus. • 4: 00 pm called her mother Serious Case ? Causality ?
Case Narrative N°2 • A phone call from an adult woman has been received on July 19, 2011, who said :” On July 15, 2011, my daughter and I used the deodorant X and we developed immediately a stinging feeling under the arms. One hour later, it turned out as red spots. It was very visible as we both shaved our axilla on the day before.” • The product was correctly applied and previously used without any reaction. Product was not used after July 15th. • The reaction disappeared spontaneously within 15 minutes for the stinging sensation and a few hours fort he red spots. • No medical investigations were performed.
Case Assessment N°2
• There are two case reports. Both are valid.
• It is not a serious undesirable effect.
• The symptoms could be in relation with the application of a deodorant for
several reasons :
– their nature,
– their localization,
– Even if shaving axilla may be partly responsible, the reactions were
not observed before applying the deodorant AND it may be
reasonably expected for a deodorant to be applied on shaved axillae.
• The chronology of events is compatible for both events.
• Causality assessment :
– Symptomatology: evocative
– Chronology: Compatible Likely related
– Re-exposure/investigations: ?Case Narrative N°3 • A 17-year old man experienced severe itching and rash on the scalp after the first and single use of a hair styling product. • The reaction worsened over the next 2 weeks. A dermatologist was consulted and a medicated shampoo was prescribed. The patient used the medication only twice and than discontinued because he felt that the product didn’t suit him. The reactions temporarily improved but recurred 2 months later. The outcome of the reactions is unknown. Serious Case ? Causality ?
Case Assessment N°3 • Medical history obtained from treating doctor : already experienced these symptoms several times in the past, but he never consulted a dermatologist until now • Medical consultation: yes • Final diagnosis: seborrheic dermatitis Serious Case ? Causality ?
Case Assessment N°3 • The case is valid and is non serious. • Symptoms are evocative • Chronology is not clearly compatible (persistance of symptoms 2 weeks after discontinuation, reoccurance without re-exposure) • History indicates an underlying disease which can explain the reported symptom. Medical investigation is needed which was not possible in this case. • The case is not clearly attributable (or excluded).
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