Finnish Safety and Chemicals Agency - Serious Undesirable Effects in Cosmetics Regulation
The Finnish Safety and Chemicals Agency (Tukes) discusses serious undesirable effects in cosmetic products, including definitions, criteria, obligations, and safety requirements to ensure a high level of consumer protection. Learn about the types of effects, notification tools, and regulatory measures to address such issues.
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Finnish Safety and Chemicals Agency (Tukes) Jarkko Loikkanen, Senior Officer Communication of Serious Undesirable Effects, Information on Substances TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products 22-23 February 2016, Belgrad (Serbia)
Topics SERIOUS UNDESIRABLE EFFECTS Definitions Criteria OBLIGATIONS Responsible person Distributor Authority NOTIFICATION AND TOOLS SUE forms (A, B and C) ICSMS CAUSALITY ASSESSMENT Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Safety requirement One of the main objectives of EU s Cosmetics Regulation: High level of protection of human health Some consumers may experience undesirable effects Most common undesirable effects related to use of cosmetic products: Local irritation Allergic reactions Some effects may also be serious in nature Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Definitions (article 2) Undesirable effect: Means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product Serious undesirable effect (SUE): Means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Temporary or permanent functional incapacity Temporary or permanent physical damage affecting the quality of life and/or making difficult to exercise usual occupation and/or activities Examples: A work stoppage or sick leave (e.g. hairdresser with an allergy to hair colouring products) An event requiring medical observation in an emergency room without an hospitalization thereafter (e.g. facial oedema, respiratory problems); Significant changes in physical appearance (e.g. allergy reactions on face and body, hair loss, burns ...). Temporary loss of primary sense (e.g. vision or taste) Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Disability Long-term impairment (e.g. physical, mental, intellectual, sensory) which in interaction with various barriers may hinder full and effective participation in society on an equal basis with others Disability should be established medically Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Hospitalization Admission to the hospital whatever the delay between the cosmetic use and the hospitalization if a causal relationship is suspected Not considered as hospitalization (without admission): A treatment in an emergency room Consultation in a hospital Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Congenital anomaly A congenital anomaly in a child which may have resulted form an exposure of: either mother or father to a cosmetic product prior to conception Mother during pregnancy This should refer to a physiological or structural anomaly still present at the birth This excludes hereditary diseases Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Immediate vital risk Event In which the subject was at risk of death at the time of the event Whose natural evolution without medical treatment might have have resulted in the death of the patient within 24 h Examples: Allergic bronchospasm Anaphylactic shock Vital risk does not refer to an event/reaction which hypothetically might have caused death if it was more severe Death o Death after the cosmetic use if a causal relationship is suspected whatever the delay Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Communication of serious undesirable effects (SUE) EU s Cosmetics Regulation (No 1223/2009): Article 23 Responsible person and distributors Obligation to notify all SUE cases to the CA of the MS where SUE occured Without delay (20 calendar days) Standardised SUE reporting form Initial report Follow-up report (if relevant new information obtained) End users and health professionals No obligation to notify Recommendation to notify responsible person or distributor Can also directly notify the CA of the MS where SUE occured Only SUE cases to authorities (not UEs) Responsible person and distributor should ensure that the case in question fulfils the seriousness criteria Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
The role of the CA in communication of SUE Upon receiving SUE notifications Check the information provided (e.g. are seriousness criteria fulfilled) Causality assessment Transmit the information immediately (20 calendar days) 1) to the CAs of the other Member States and also 2) to responsible person, if original notification from distributor, end user or health professional ICSMS The internet-supported information and communication system for the pan- European market surveillace https://webgate.ec.europa.eu/icsms/ Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
SUE forms, instructions and guidelines 1) SUE A Form Responsible person and distributor Available in all the official EU languages Instructions on Form A available only in English Include all available information on the case Suspected cosmetic product (Full name, CPNP number etc) 2) SUE B Form Used by authorities Original notification from responsible person or distributor (SUE A ) 3) SUE C Form Use by authorities Original notification from end user or health professional European Commission: http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm SUE reporting guidelines + causality assessment SUE forms and instructions on forms National contact points in charge of SUE Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
SUE notifications Standardised forms to be used Minimun information for the initial notification 1. An identifiable reporter 2. The nature of the alleged SUE and the date of its onset 3. The name of the cosmetic product concerned enabling its specific identification (CPNP number) Identification and traceability of SUEs Company and CA case identification numbers Data privacy protection and confidentiality issues Confidentiality of the information End users and/or notifiers (e.g. health professional) should not be identified by their name and address Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
SUE notification: Responsible person or distributor Responsible person Distributor SUE A SUE A SUE A + B End users Health professionals End users Health professionals National CA SUE A + B CAs of the other Member states Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
SUE notification: End user or health professional Responsible person SUE C Health professional National CA End user SUE C CAs of the other Member states Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Causality assessment Annex 1 to SUE reporting guidelines The aim of the causality assessment is to assess cause- and-effect relationship between cosmetic products and given clinical and/or paraclinical effects Should be included in SUE notification by responsible person and also by distributor (if possible) Assessment includes Chronological score: time sequence between use of the cosmetic product and occurence of the symptoms Semiological score: nature of the effect + the results of any specific additional examination (AE) or of re-exposure (RE) Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Additional examinations and re-exposure Results of additional examinations (AE) rated AE (+): positive AE (-): negative AE (?): if no examinations were performed or if the results were ambiguous Criteria for AE Must be reliable Specific to the observed effect Performed by specialist physicians Outcome of re-exposure (R) to the cosmetic product R (+): positive; initial symptomatology recurs with the same intensity or with a higher intensity R (?): no re-exposure to the product or the conditions of re-exposure are not identical to those of the initial exposure R (-): negative; the effect does not recur when the user is re-exposed to the product Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Causality assessment The chronological and semiological scores are combined Decision table or Decision tree 5 levels of causality Very Likely Likely No clearly attributable Unlikely Excluded Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Symptoms EVOCATIVE of use of the cosmetic product ONLY PARTIALLY OR NOT EVOCATIVE of use of the cosmetic product Time sequence between exposure and occurrence of the symptoms Rand/orAE Rand/orAE Rand/orAE Rand/orAE Rand/orAE Rand/orAE + ? - + ? - Compatible Very likely Likely Not clearly attributable Likely Not clearly attributable Unlikely Only partially compatible or unknown Likely Not clearly attributable Unlikely Not clearly attributable Unlikely Unlikely Incompatible Excluded Excluded Excluded Excluded Excluded Excluded Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Symptoms Chronology Compatible Chronology Only partially compatible or unknown AE and/or RE AE and/or RE AE and/or RE AE and/or RE AE and/or RE AE and/or RE Not Not performed or equivocal results performed or equivocal results Negative Negative Positive Positive Not clearly attributable Not clearly attributable Likely Very likely Likely Unlikely Symptoms: If the symptoms are not evocative (not suggestive of the product effect), the final level of causal relationship is decreased by one degree Compatible chronology: A time sequence between product use and the occurence of symptoms as well as between stopping product use and clearing up of the symptoms which is plausible. If not compatible excluded Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Subsequent actions Responsible person Analysis of the data Inclusion in the cosmetic product safety report Information to the public Corrective action Competent authorities Evaluation of trend or signal detection End user information Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Information on substances (Article 24) Serious doubt regarding the safety of a substance CA by reasoned request may require responsible person to submit a list of all cosmetic products under his responsibility and which contains this substance Indicate the concentration of this substance in products CAs may use the information referred to in Article 24 for the purposes of In-market surveillance Market analysis Evaluation Consumer information in context with: Article 25 (Non-compliance by the responsible person) Article 26 (Non-compliance by distributors) Article 27 (Safeguard clause) Finnish Safety and Chemicals Agency Jarkko Loikkanen, TAIEX Workshop 2016 Belgrad (Serbia)
Thank you! jarkko.loikkanen@tukes.fi Finnish Safety and Chemicals Agency
