EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
[…](2012) XXX  draft 
  
COMMISSION IMPLEMENTING DECISION 
of XXX  
on Guidelines on Annex I to Regulation  (EC) No. 1223/2009 on cosmetic products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION 
of XXX 
on Guidelines on Annex I to Regulation  (EC) No 1223/2009 on cosmetic products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products
1, and in particular th e third subparagraph 
of Article 10(1) thereof, 
Whereas: (1) It is essential that cosmetic products made  available on the Union market be safe for 
human health when used under normal and reasonably foreseeable conditions of use. To that end, Regulation (EC) No 1223/2009 requ ires that, in order to establish that a 
cosmetic product is safe under those conditions, cosmetic products undergo a safety assessment. 
(2) The operator designated as the responsible person in accordance with Regulation (EC) 
No 1223/2009 is to ensure that, for each cosmetic product which is to be placed on the Union market, a cosmetic product safety repor t is drawn up on the basis of the relevant 
information and in accordance with the requirements laid down in Annex I to Regulation (EC) No 1223/2009. 
(3) In order to facilita te the understanding of  the requirements of Annex I to Regulation 
(EC) No 1223/2009 by all undertakings, an d especially small and medium-size 
enterprises, the Regulation requires that the Commission adopts appropriate 
guidelines. 
(4) This Decision sets out appr opriate guidelines on Annex I to Regulation (EC) No 
1223/2009. They were developed with the cont ribution of the relevant stakeholders, 
including representatives of sma ll and medium-sized enterprises. 
(5) The guidelines should assist responsible pe rsons in complying with their regulatory 
obligations. However, they are not meant to replace the knowledge and expertise of 
the qualified safety assessor, as require d by Article 10(2) of Regulation (EC) No 
                                                
 
1 OJ L 342, 22.12.2009, p. 59.  
EN 3   EN 1223/2009, who should remain the only professi onal allowed to carry  out the cosmetic 
product safety assessment as described in Part B of Annex I.  
(6) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS DECISION:  
Article 1 
The guidelines to enable undertakings to comply  with the requirements laid down in Annex I 
to Regulation (EC) No 1223/2009 on cosmetic pr oducts are set out in the Annex to this 
Decision. 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 4   EN ANNEX  
Guidelines on Annex I to Regula tion (EC) No 1223/2009 on the 
Cosmetic Product Safety Report 
1. INTRODUCTION  
Article 11 of Regulation (EC) No 1223/2009 requires th at a product information file is drawn up for each 
product before it is placed on the market. The produc t information file should be updated when necessary 
and kept readily accessible, in electronic or other form at, at the address of the responsible person given on 
the label, to the competent author ities for market surveillance purposes for a period of ten years following 
the placing on the market of the last batch of the product. 
The most important element of the product information file, from a safety point of view, is the cosmetic 
product safety report referred to in Article 10(1). The ot her elements are a clear d escription of the cosmetic 
product, a description of the method of manufac turing and a statement on compliance with good 
manufacturing practice, the proof of the effects claimed, and data on animal testing2.  
Where the responsible person drawing up the cosmetic pr oduct safety report is not the manufacturer of the 
product, they should ensure they have access to all the technical and scientific skills necessary to obtain 
reliable cosmetic product safety information and an a ppropriate safety assessment to demonstrate that the 
product they are responsible for is safe, in accordance w ith Article 3 of Regulation (EC) No 1223/2009. They 
may therefore need to involve not only the safety assesso r, but also the manufacturer, the suppliers of raw 
materials, and other technical experts. 
In any case, the responsible person is to ensure that  the intended use of th e cosmetic product and the 
anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the 
safety assessment; an appropriate weight-of-evidence appr oach is used in the saf ety assessment for reviewing 
data from all existing sources; the cosmetic product safet y report is kept up to date  in view of additional 
relevant information gene rated subsequent to placing the product on the market3. 
The cosmetic product safety assessment, as set out in Part  B of Annex I to Regulati on (EC) No 1223/2009, is 
to be carried out by a qualified safety assessor . The responsible person and the safety assessor should work 
closely together to ensure that the safety of the product is properly assessed and documented and that the 
assessment is kept up to date. The responsible pers on and the safety assessor should gather all the necessary 
information as required by Part A of A nnex I to Regulation (EC) No 1223/2009. 
The cosmetic product safety report should be drawn up in a transparent way and should be well-argued and 
easily understood. 
The Cosmetic Product Safety Report is an expert piece of work made up of different modules and where the 
information required under Part A may be stored in diffe rent databases. The report, which should contain, as 
a minimum, all the information indicated in Annex I to Regulation (EC) No 1223/2009, should appear under 
the same or similar headings for ease of reference of the competent authorities. However, it may be sufficient 
                                                 
2 Article 11(2) of Regulation (EC) No 1223/2009. 
3 Article 10(1) of Regulation (EC) No 1223/2009.  
EN 5   EN to provide under each heading a clear reference to a document containing the information and readily 
available in electronic or printed format.  
2. ANNEX I TO REGULATION (EC)  NO 1223/2009  — COSMETIC PRODUCT SAFETY REPORT  
In accordance with Annex I to Regulation (EC) No 1223 /2009, the Cosmetic Product Safety Report is to 
contain, ‘as a minimum ’, the information required under each of the headings of Part A and Part B. 
Part A aims to gather all the data necessary for the safety assessment of the product, while Part B sets out the 
reasoning, starting from the data, for drawing conclusions as to the safety of the product. 
The structure and content of the safety report should re flect the requirements of Annex I to Regulation (EC) 
No 1223/2009. However, if the report does not directly contain the required information, it should provide a 
reference to another readily available source. 
The responsible person is to  ensure that the Cosmetic Pr oduct Safety Report is kept up to date in the light of 
additional relevant information emerging afte r the product has been placed on the market.4 
3. PART A — COSMETIC PRODUCT SAFETY INFORMATION  
Part A of the cosmetic product safety report is  intended to gather the data necessary to prove 
that the cosmetic product is safe. The informatio n should enable the safety assessor to clearly 
identify and quantify, based on the identified  hazards, the risks a cosmetic product may 
present to human health. A hazard may arise,  for example, from the raw materials, the 
manufacturing process, the packaging, the conditions of use of the product, the 
microbiological specifications, the quantities used , the toxicological profile of the substances, 
etc. 
As Part A of Annex I to Regulation (EC) No  1223/2009 requires that the data listed under its 
headings are provided as a minimum, any dis crepancy with regards to  the requirements of 
Part A should be justified. 
Part A of Annex I to Regulation (EC) No 1223/2009 lists the data that is to be available, ‘as a minimum’,  
for the safety assessor to be able to carry out the safety assessment. 
In addition to the minimum data listed in Part A of  Annex I to Regulation (EC) No 1223/2009, the safety 
assessor can use any additional data, wh ere relevant. On the other hand, th ey, or the responsible person, may 
consider that, depending on the type of product, some of the required da ta are not relevant or necessary to 
assess the safety of the product (e.g. preservation challenge test). In this case, the absence of specific data is 
to be clearly justified in Part A and the justificati on is to be repeated and validated by the safety assessor in 
their reasoning in Part B. The responsible person s hould check the presence of the required data or the 
justification for their absence.  
The data required by Part A can be drawn from any reliable source. Examples in clude: data from suppliers, 
scientific literature, experience gained with similar or  other product categories, results of studies on the 
                                                 
4 Article 10(1)(c) of Regulation (EC) No 1223/2009.  
EN 6   EN product itself or on the substances it contains, availabl e data on similar formulations, or computer models. 
The safety report should highlight the relevan ce of the data in relation to the product. 
The guidance published by the EU scientific committees concerned with risk assessment,5 as well as the 
recommendations of national competent authorities or  professional organisati ons, may provide further 
helpful support.  
3.1. Quantitative and qualitative composition of the cosmetic product 
The aim of that section of the cosmetic pr oduct safety report is to provide the exact 
quantitative and qualitative composition of th e finished product, starting from the raw 
materials. Raw materials are substances or mixtures used in the manufacturing of the 
cosmetic product. The intended function of  each substance is to be indicated. 
The complete product composition is to be specified, st ating the name and identity (qualitative) of each raw 
material (including chemical name, INCI, CAS, EINE CS/ELINCS, where possible), and the amount of each 
raw material, stating the weight percentage (quantit ative). Ranges should not be used, unless this can be 
justified (e.g. viscosity or pH adjusters). If c oncentration ranges are unavoidable, toxicological 
considerations and calculations should be based on the highest concentration figure. It may also be useful to 
indicate the supplier(s) of the raw materials.  
All substances entering into the composition of comme rcial mixtures supplied as raw materials (including 
directly added preservatives, antioxidants, chelators, bu ffering agents, solvents, other additives, etc.) are to 
be identified and quantified in the formula of the fini shed product. This also applies to all substances 
indirectly added to the product, such as preservati ves used for preserving raw materials. The intended 
function of each substance is to be indicated. 
When chemically well-defined substances are present, their quantity and molecular formula should be given 
together with their analytical specifications (degree of  purity, identification of major impurities, criteria and 
test methods used). 
When complex ingredients are presen t, their nature and quantity together with a clear definition of the 
mixture and the material(s) used should be given in or der to identify the substances with regard to their 
composition and effects (manufacturing and purificati on processes, including physical, chemical, enzymatic, 
biotechnological and microbiological steps). The purity criteria and test methods used should be provided. 
Examples of complex ingredients include those of mineral, botanical, animal or biotechnological origin. The 
scope of the information needed on complex ingredient s, depending on their nature and origin, is explicitly 
listed in the Scientific Committee for Consumer Safety (SCCS)  Note of Guidance.6  
When a mixture of both chemically well-defined subs tances and complex ingredients is present, the above 
guidance also applies. 
Where any fragrance (or flavour) compound comprising a mi xture of fragrance (or flavour) ingredients and 
functional components with olfactory, odour-enhanc ing, odour-protecting or blending properties is 
formulated and intentionally added to a cosmetic pr oduct to impart a scent (or flavour) or to cover a 
                                                 
5 The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th 
Revision, SCCS/1501/12, and its subsequent updates. 
6 SCCS Notes of Guidance, para. 3-6.2, pp. 35-36.  
EN 7   EN malodour, its identification is to include the name a nd code number as well as the identity of the supplier. 
Qualitative and quantitative informa tion about regulated substances in the fragrance (or flavour) compound 
and information relevant for a safety assessment should be disclosed to the responsible person and the safety 
assessor, and should be included in the safety report. 
3.2. Physical/chemical characteristics and stability of the cosmetic product 
The aim of that section of the cosmetic produc t safety report is to describe the relevant 
physical and chemical specifications of the subs tances or mixtures used and the cosmetic 
product itself. These specifications are crucial fo r an appropriate safety assessment, as they 
may influence the safety of a cosmetic product.  For example, physico-chemical properties, in 
combination with other information, can help  the safety assessor determine the need to 
investigate relevant toxicological parameters. 
In addition, the physico-chemical characteristics of the substances or mixtures and finished 
products set the benchmark against which the products and the raw materials can be 
considered acceptable from a quality point of view.7  
That section of the cosmetic product safety repo rt also requires an assessment of the stability 
of the cosmetic product, under reasonably fo reseeable storage conditions. The aim is to 
evaluate if the stability of the cosmetic product affects the safety and quality of the product, 
and to use the information to determine it s minimum durability and period-after-opening 
(PAO). 
3.2.1.  Physical/chemical characteristic s of substances or mixtures 
This description is to include the most relevant phys ico-chemical properties of each substance and mixture 
contained in the product, for example: chemical identif ication, physical form, molecular weight, solubility, 
partition coefficient, substance purity, other paramete rs relevant for the characterisation of specific 
substances and mixtures, and, for polymers,  the average molecular weight and range. 
Where relevant, the particle-size di stribution curve of substances should be included in the physico-chemical 
characteristics, especially for nanomaterials. 
Cosmetics manufacturers should ensure that the specifi cations of raw materials are properly documented by 
their suppliers. Specifications should be available for each  raw material actually used in the product. Based 
on function, additional specifications may be needed. Fo r UV absorbers, for instan ce, the absorption spectra 
should be provided. 
For each description of physico-chemical properties and specifications (for each substance and mixture 
contained in the product), the reference methods  should be stated in the safety report. 
                                                 
7 This point is relevant in the context of Good Ma nufacturing Practices, and is explicitly addressed by the 
relevant standard EN ISO 22716:2007. More specifically , it matches the requirements for the release of raw 
materials and the finished product.  
EN 8   EN 3.2.2.  Physical/chemical characteristics of the finished cosmetic product 
This description is to contain the specifications of th e finished product. Each specification should be given 
with relevant limits, e.g . pH between 5.5 and 6.5. 
For each description of physico-chemical properties and sp ecifications of the finished  product, the reference 
methods should be stated in th e cosmetic product safety report. 
3.2.3.  Stability of the cosmetic product 
As the requirement is to assess the stability of th e cosmetic product under reasonably foreseeable storage 
conditions, if stability is dependent  on storage conditions, informati on about these conditions should be 
passed on throughout the supply chain, and, if releva nt for the end user, it should be indicated on the 
labelling of the product. 
The methodology used to determine the product’s minimum durability should be described. Any specific 
preservation precautions should be mentioned. 
All available data used to justify the indicated mini mum durability should be listed in the safety report. In 
order to determine the coherence of the stability study conducted, and to check the relevance of the date of 
minimum durability chosen for the product, the description of the tests specific to the stability study and the 
results of those tests should be included in the cosm etic product safety report. In addition, the following 
should also be provided: 
(1) Evidence that the composition of the product used for stability te sting corresponds to 
the product actually pl aced on the market; 
(2) The results of the preservative efficacy st udy, e.g. challenge test, if applicable;8  
(3) When applicable, the period-after-opening (PAO)9 and its justification. 
The SCCS has recommended that ‘ relevant stability tests, adapted to th e type of cosmetic product and its 
intended use, should be carried out. To make sure that  no stability problems are induced by the type of 
container and packaging used, physical stability tests are currently carried out with inert containers and 
those intended to be used on the market. ’10 
3.3. Microbiological quality 
The aim of that section of the cosmetic product safety report  is to determine the acceptable 
microbiological specifications of the raw mat erials (substances or mixtures) and finished 
product from a microbiological point of view. In  accordance with Annex I to Regulation (EC) 
No 1223/2009, particular attention is to be paid  to the microbiological specifications of 
cosmetic products intended to be used on sensit ive body parts and on specific populations. In 
                                                 
8 See section 3.3 on Microbiological quality. 
9 See ‘Practical implementation of Article 6(1)(c) of  the Cosmetics Directive (76/768/EEC)1: LABELLING OF 
PRODUCT DURABILITY: ‘PERIOD OF TIME AFTER OPENING’ 
http://ec.europa.eu/consumers/sector s/cosmetics/files/doc/wd-04-entr-
cos_28_rev_version_adoptee20040419_en.pdf. 
10 SCCS Notes of Guidance, para. 4-3.3, p. 74.  
EN 9   EN addition, information regarding microbiological quality is essential in order to justify the 
effectiveness of the preservation system and ju stify the indicated minimum durability of the 
cosmetic product stored under appropriate conditions  and period-after-opening (PAO)11 of 
the finished product in terms of safety. 
The microbiological specifications of the raw materials (substances or mixtures) and cosmetic product are to 
form part of the safety assessment. Particular attention is to be paid to the microbiological specifications of 
cosmetic products intended to be used around the eyes,  on mucous membranes in general, on damaged skin 
(e.g. skin care products suitable for atopic or irritated skin), on children under three years of age, on elderly 
people or on persons with compromised immune responses. 
3.3.1.  Microbiological quality of substances and mixtures 
The main parameters for microbiological quality are the original level of contamination and the possibility of 
microbial growth. Particular attention should be paid  to the raw materials (substances and mixtures) most 
susceptible to microbial growth (e.g. water-based mixt ures, protein-rich materials, plant or animal raw 
materials). On the other hand, there are raw material s which do not support microbial growth, e.g. organic 
solvents. 
3.3.2.  Microbiological quality of th e finished cosmetic product 
Concerning microbiological susceptibility, there is  a difference between three product categories: 
(1) Low microbiological risk products (e.g. pr oducts with an al cohol content >20  %, 
products based on organic solvents, high/ low-pH products), for which neither a 
preservation challenge test nor microbiol ogical quality tests on the finished product 
are necessary. A scientific justific ation is to be provided, however; 
(2) Single-use products, and products which cannot be opened (e.g. for which the 
packaging allows dosing the product without it coming in contact with the air), for 
which only microbiological quality tests on the finished product are necessary. A 
scientific justification is  to be provided, however; 
(3) All other products, for which both a preserva tion challenge test and microbiological 
quality tests on the finish ed product are necessary. 
Specific ‘Guidelines on Microbiological Quality of the Fi nished Product’ are provided in the SCCS Notes of 
Guidance.12  
                                                 
11 The ‘date of minimum durability’ is the date until which the cosmetic product, stored under appropriate 
conditions, will continue to fulfil its initial function and, in particular, will remain safe; the PAO is the period 
of time after opening for which the product can be used without any harm to the consumer. See ‘Practical 
implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC)1: LABELLING OF PRODUCT DURABILITY: ‘PERIOD OF TIME AFTER OPENING’. 
12 SCCS Notes of Guidance, para 4-4, pp. 75–76.  
EN 10   EN 3.4. Impurities, traces, information about the packaging material 
The aim of that section of the cosmetic product safety report is to assess whether the cosmetic 
product contains substances that have not been  intentionally added to the formulation, and 
which may have an impact on its safety. 
Impurities are unintended substances in raw materials.  
A trace is a small quantity of an  unintended substance in the fini shed product. Traces are to 
be evaluated with regard to safety of the fi nished product. When traces of prohibited 
substances are present, eviden ce of their technical unavoidability are also to be provided. 
Traces can originate from the following sources : impurities in the raw materials/substances; 
the manufacturing process; potential chemical  evolution/interaction and/or migration of 
substances in the product that could occur under normal storage conditions and/or through 
contact with the packaging material. 
Because substances may migrate from the pa ckaging to the formulation, the relevant 
characteristics of the packaging material are to be considered. 
In accordance with point 4 of Annex I to Regulatio n (EC) No 1223/2009, the section on ‘Impurities, traces, 
information about the packaging material ’ is to address three specific issues: 
(a) The purity of substances and mixtures; 
(b) In case of traces of prohibited substances, evidence of their technical unavoidability; 
(c) The relevant characteristics of the pack aging material, in particular purity and 
stability. 
In practical terms, those elements may be interpreted as follows: 
(a) Precise definition of impurit ies and traces (see 3.4.1); 
(b) Evidence of technical unavoidability  of prohibited substances (see 3.4.2); 
(c) Potential release of substances from the packaging or possible deterioration of the 
product in contact with the packaging (see 3.4.3). 
For the analysis of impurities and packaging material , data from suppliers are of crucial importance and 
should be preferred. 
3.4.1.  Purity of substances and mixtures 
The presence of unintended substances, such as impurities a nd traces, can have an impact on the safety of the 
finished product. The cosmetic product safety report is to include data on the purity of raw materials 
(substances and mixtures) and the identification of the toxicologically relevant unintended substances. These 
substances should be taken into account in  the safety assessment of the product. 
Impurities are unintended substances in raw materials.  
EN 11   EN A trace is a small quantity of an uninten ded substance in the finished product.  
The presence of traces in the finished pr oduct can be evaluated in two ways: 
(d) through the specifications/technical data fo r each raw material, based on knowledge 
of the process for manufact uring the raw material (ori gin of substance, production 
process, synthesis route, extracti on process, solvent used, etc.);  
(e) through a physico-chemical analysis of po ssible impurities in raw materials and, if 
necessary, in the final product (e.g. nitrosamines which are potentially generated during or after the manufacturing process). 
Traces of prohibited substances are dealt with  in paragraph 3.4.2 of these Guidelines. 
Some traces have regulatory concen tration limits. For the presence of traces of substances that are not 
prohibited, and for which there are no regulatory concentration limits, but which could be expected to impact 
consumer safety, the safety assessment needs to be carried out by the safety assessor. 
3.4.2.  Evidence of the technical unavoidability of traces of  prohibited substances 
While the procedure outlined in paragraph 3.4.1 shou ld be followed for all known impurities and traces to 
evaluate their toxicological impact, further investig ation is required for proh ibited substances present as 
traces in the finished product13. 
When such presence is technically unavoidable, the cosmetics manufacturers are required to provide 
evidence of the technical unavoidabili ty. That means they have to jus tify the presence of those traces by all 
necessary means. The presence of traces of prohibited substances should be kept as low as is reasonably 
achievable under good manufacturing practices. In addition,  the safety assessor has to decide whether their 
levels are toxicologically acceptable and whether the product is still safe. 
Especially in the case of non-threshol d genotoxic and carcinogenic substances14, the cosmetic industry 
should keep improving its best practices in order to eliminate these substances (ALARA principle15) in the 
finished cosmetic product. The main concern is to ensure the protection of human health, as required by 
Article 3 of Regulation (EC) No 1223/2009. 
Traces generated by the degradation of substances w ithin the final product (stability issues), by preservation 
or transport problems, or by the interaction of raw materials should be avoided through good manufacturing 
practices, or possibly through re-formulation of the product. 
3.4.3.  The relevant characteristics of packaging material 
Packaging material means the container (or primary packaging) that is in direct contact with the formulation. 
The relevant characteristics of packaging materials in direct contact with the final product are important for 
                                                 
13 Article 17 of Regulation (EC) No 1 223/2009 establishes that traces of prohibited substa nces are only permitted 
if they are technically unavoidable and if they have no impact on the safety of the cosmetic products. 
14 The 'non-threshold genotoxic and carcinogenic substances' are the genotoxic and carcinogenic substances 
without  a threshold for the carcinogenic-genotoxic effects. 
15 Opinion of the Scientific Committee on a request from  EFSA related to A Harmonised Approach for Risk 
Assessment of Substances Which are both Genotoxic and Carcinogenic , The EFSA Journal (2005) 282, pp. 1-
31.  
EN 12   EN the safety of the cosmetic product. Reference to Regulation (EC) No 1935/ 2004 of the European 
Parliament and of the Council16 could be useful. 
Experience with similar formulation/packaging comb inations already on the market provides useful 
indications. Materials that have been developed for food packaging have often already been tested, so 
relevant information on stability and migration may be available.  Additional testing may not be required. 
However, more evaluation may be needed for new or novel packaging. 
The combination of packaging material, formulation of  the cosmetic product and contact with the external 
environment may have an impact on the safety of th e finished product, due to the following factors: 
(a) interaction between the product and the packaging material; 
(b) barrier properties of the packaging material; 
(c) substance migration from/to the packaging material. 
The information on relevant characteristics of the pack aging materials in direct contact with the product 
should allow an estimation of potential risks. Releva nt characteristics could include, for example, the 
following: 
(a) composition of the packaging material, including  technical substances such as additives; 
(b) technically unavoidable impurities; 
(c) possible migration from the packaging. 
This information only indicates the hazard. It is up to the safety assessor to evaluate the risk17.  
Studies on interactions/suitability between formula tion and packaging allow testing of the potential 
migration of small amounts of substances from the primary packaging material to the product. These tests are 
performed under specific and relevant test conditions . There are, however, no standard procedures for 
cosmetic products. An appropriate assessment may be made based on knowledge of the formulation and 
primary packaging materials and experienced expert judgment. 
If migration is dependent on storage conditions, the co rrect conditions should be indicated on the product 
labelling. If the formulation is sensitive to light or air, and would degrade in a way that impacts product 
safety or product efficacy, appropria te packaging should be used. 
3.5. Normal and reasonably foreseeable use 
The section on normal and reasonably foreseeable use of the product is essential for the safety 
assessor to be able to determine a relevant exposure scenario. The intended use should be 
appropriately communicated to the consumer in  order to avoid misuse of the product. 
                                                 
16 OJ L 338, 13.11.2004, p. 4. 
17 To evaluate the risk, one needs to consider the hazard together  with the exposure, and this is the duty of the 
safety assessor.  
EN 13   EN In addition, warnings and other explanations on  the labelling should be consistent with the 
identified normal and reasonably foreseeable use,  and the reasoning justifying their inclusion 
is to be given. 
A clear explanation of the normal intended use and the reasonably foreseeable use should be provided. For 
instance, in the case of a shampoo, the normal intended use would be to use it on the scalp; an (unintended) 
reasonably foreseeable use would be for it to be used as a shower gel. Ingestion would be a clear misuse. 
To this end, a practical approach may be useful. For example, one could include a photo of the packaging or 
the artwork in the cosmetic product safety report to show  the presentation of the product and its intended use. 
It would also be useful to make the link with the warnings and labelling, as highlighted by Annex I to 
Regulation (EC) No 1223/2009 on this point. 
3.6. Exposure to the cosmetic product 
The exposure assessment is an essential element of  risk assessment. The ai m of this section is 
to quantify the amount of cosmetic product coming  into contact with the external parts of the 
human body or the teeth and the mucous memb ranes of the oral cavity under normal or 
reasonably foreseeable use for each  use and the frequency of use. 
The assessment of exposure to the cosmetic product sh all take into consideration the findings regarding 
‘normal and reasonably foreseeable use’ under section 5 of Annex I to Regulation (EC) No 1223/2009 in 
relation to a set of elements that are explicitly listed in section 6. Secondary exposure routes should also be 
taken into consideration, where appropriate. 
The description of concrete conditions of use for the purpose of exposure analysis should also take the 
following parameters into account: 
(a) product type (e.g. leave-on, rinse-off); 
(b) area of application (e.g. w hole body, eyes, mouth cavity); 
(c) amount per application in the case of norma l and reasonably foreseeable use, e.g. 
including when a shampoo is used as shower gel; 
(d) duration and frequency; 
(e) possible (foreseeable) routes of exposure (e.g. oral for lipstick and toothpaste, or 
inhalation for aerosols and solvents); 
(f) target group for use (e.g. children under the age of three years, adults); 
(g) impact of particle size on exposure. 
The SCCS Notes of Guidance provide useful informati on on exposure calculations a nd particularly relevant 
tables.18 
                                                 
18 SCCS Notes of Guidance, para 4, p. 66 et seq .  
EN 14   EN However, as the tables may not contain the daily expo sure values for specific cosmetic products, other ways 
of calculating exposure may be used. Several alternativ es are possible. For instance, calculations could be 
performed based on either skin surf ace data or user experience data. 
If the available data are considered insufficient, it is recommended to assume a worse-case exposure taking 
into account the foreseeable conditions of use. 
The specific target population and the populations otherw ise exposed to the product should be kept in mind. 
For example, in the case of products for professional u se, there will be different exposure scenarios for the 
targeted consumers and the exposed professionals in  terms of exposure frequency, exposure duration and 
size of exposed skin area, possible exposure through i nhalation (for example, in the case of shampoos, when 
assessing the risk for consumers, exposure of the scalp with a frequency of approximately once a day should 
be considered, whereas for hair dressers exposure of th e hands several times a day should be considered). 
3.7. Exposure to the substances 
The assessment of the exposure to each of the s ubstances contained in the cosmetic product is 
necessary in order to assess the risk associated with each individual substance. The objective 
of that section of the cosmetic product safety  report is to determine the amount of each 
substance coming into contact with the external  parts of the human body or the teeth and the 
mucous membranes of the oral cavity under norm al or reasonably foreseeable use, for each 
use. 
Exposure to each of the substances in the cosmet ic product is calculated from the exposure to 
the final product and the concentration of the individual substances in the final product. It is 
necessary to calculate this exposure in order to  assess the potential risk from each substance. 
Exposure to individual substances is calculated fro m the quantitative composition of the product. Where 
substances are generated or released during the use of  the product, the exposure should be estimated and 
taken into account in the safety assessment. 
The exposure conditions to each individual substance ar e determined by those fo r the finished cosmetic 
product under 3.6. 
3.8. Toxicological profile of the substances 
The aim of this section of the cosmetic product safety report is to describe the toxicological 
hazard of each of the substances in the fini shed product, determine the potential exposure, 
and draw up a risk characterisation. These asp ects are of crucial importance in order to 
perform the risk assessment, as  they are the three essential st eps of the risk assessment 
process.19  
The endpoints to be considered, as well as the necessary data, depend on a number of factors, 
including the routes of exposure, the conditions of use of the product, the physico/chemical 
                                                 
19 M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed 
Challenge to Science , Toxicology and Applied Pharmacology, 243 (2010), p. 261.  
EN 15   EN characteristics and the possible ab sorption of the substance. Th e choice of relevant endpoints 
should be the responsibility of the safety as sessor, who should justify their decisions. 
The safety assessor should ensure  that the experimental data co mply with the requirements of 
Article 18 of Regulation (EC) No 1223/2009 concern ing animal testing. Such requirements are 
clarified in the Commission Communication on the animal testing and marketing ban and on 
the state of play in relation to alternat ive methods in the field of cosmetics20. 
Point 8 of Part A of Annex I to Regulation (EC) No 1223/2009 establishes the key requirements for the 
cosmetic product safety report as far as the toxico logical profile of substances is concerned. 
3.8.1.  General considerations concerning the toxi cological profile as part of the safety 
assessment 
The relevant elements of the toxicological profile of each substance or mixture should be described in detail 
in the cosmetic product safety information (Part A) a nd assessed in the safety assessment (Part B), bearing in 
mind the exposure situation, the intrinsic toxicity (or hazard) of each substance, and the specific conditions 
of use of the product. 
Human experiences, animal studies or alternative methods  to animal testing are helpful in understanding the 
health risk for humans exposed to dangerous substances.  For the toxicological profiles, toxicological studies 
are used to identify the hazards which could be associated with a risk to humans. It is essential to consider 
the quality and limitations of the studies that have be en performed. The validity of a study should be taken 
into consideration in determining whether there is a need for new information to understand the risk to 
human health21. Studies conducted in accordance with international guidelines are the most useful, but 
unfortunately not all studies meet th ese standards. Thus, the limitations of such studies should be considered 
in assessing the toxicological profile for each substance. 
The safety assessor should ensure that the experimental da ta comply with the requirements of Article 18 of 
Regulation (EC) No 1223/2009 concerning animal t esting. The Communication from the Commission to the 
European Parliament and the Council on the animal tes ting and marketing ban and on the state of play in 
relation to alternative methods in the field of cosm etics outlines the Commission's interpretation of those 
requirements22. 
3.8.2.  Toxicological profile of s ubstances for all the relev ant toxicologi cal endpoints 
The toxicological profile for each substance is determ ined by the hazard identification and the dose-response 
characterisation. 
The first essential step in developing the toxicological pr ofile is to gather all the relevant information about 
the intrinsic properties of the substance. Such  information should include the following: 
                                                 
20 Communication from the Commission to the European Parliament and the Council on the animal testing and 
marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 
135 final. 
21 H.J. Klimisch, E. Andr eae and U. Tillmann (1997), A systematic approach for evaluating the quality of 
experimental and eco toxicological data . Regul Toxicol Pharmacol 25:1-5. 
22 See in particular point 3.1 of the Communication.  
EN 16   EN (1) As the most valuable toxicity in formation, actual test data from in vivo  or in vitro  
studies obtained in accordance w ith Council Regulation (EC) No 440/2008 
(REACH)23, recognised international gui delines, or standards (e.g.  OECD Test 
Guidelines), and performed in accordance with good laboratory pr actice principles; 
(2) Existing test data that have not been obtained in accordance with the latest 
adopted/accepted version of a test gui deline or with good laboratory practice 
standards, but which are considered valid; 
(3) In vitro  data or alternative data from valid test systems, to be used as a screening 
study to predict toxicity; 
(4) Human data and/or experience. It is in  general not acceptable to perform human 
toxicology studies for hazard identification, but , if data or experience exist, they 
should be included in the final assessment; 
(5) Human (clinical) data, includi ng data from clinical trials  and applications in other 
industries such as food and medicinal products; 
(6) Data gathered from post-marketing surveillance; 
(7) Human volunteer compatibility studies, whic h should only be used to confirm safe 
levels of use for a relevant target population;24  
(8) Read-across25 approaches, based on the chemical structure and properties of related 
substances in order to predict the toxicity  of the ingredient, grouping of substances, 
and non-testing data from  QSAR model outputs. 
Based on data obtained from all available sources, and taking into account the quality of the data, the safety 
assessor can evaluate the likelihood of adverse e ffects in humans through the ‘weight of evidence’ 
approach26. 
A prerequisite for a proper risk assessment is the ava ilability of adequate data. For additional support on this 
matter, one may consult the guidance for the preparati on of safety dossiers for submission to the Scientific 
Committee for Consumers Safety (SCCS), set out by th e Committee itself in its No tes of Guidance. Though 
these Notes of Guidance are provided fo r substances where an authorisation is needed, i.e. for colorants, 
preservatives and UV filters, or which otherwise raise con cern, the requirements they set out may be helpful 
                                                 
23 OJ L 142, 31.5.2008, p. 1. 
24 SCCS Notes of Guidance, para. 3.4.11. Also cf. opinions SCCNFP/0068/98, an earlier version of the Notes of 
Guidance, and SCCNFP/0245/99 on Basic Criteria of the Protocols for the Skin Compatibility Testing of Potentially Cutaneous Irritant Cosmetic Ingredients or Mixtures of Ingredients on Human Volunteers. 
25 Read-across is a technique for data gap filling in which information for one or more source chemicals is used 
to make a prediction for a target chemical, which is considered to be similar in some way. From ECHA, ‘Guidance on information requirements and chemical sa fety assessment Chapter R.4: Evaluation of available 
information ’, December 2011, p. 12. 
http://echa.europa.eu/documents/10162/17235/information_requirements_r4_en.pdf 
26 One definition for weight of evidence is: ‘the process of considering the strengths and weaknesses of various 
pieces of information in reaching an d supporting a conclusion concerning a property of the substance.’ From 
ECHA, 'Practical guide 2: How to report weight of evidence', 2010, p. 2, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf 
  
EN 17   EN for the safety assessment of all substances used in cosm etic products. In addition, a section of the most recent 
Notes of Guidance focuses on the safety asse ssment of finished cosmetic products27. 
The toxicological profile may address a number of different endpoints. A final decision about which 
endpoints are relevant is made by the safety assessor on  a case-by-case basis, taking into account exposure, 
use of the product, the physico-chemical characteristi cs of the substances, experience with the substances, 
etc28. Attention should also be paid to local effects (e.g.  irritation and photo-toxicity), when relevant. Where 
a certain endpoint is considered to be not relevant, this should be justified. 
Endpoints that may be relevant for the toxicological profile are: 
(1) Acute toxicity via releva nt routes of exposure; 
(2) Irritation and corrosivity; 
(3) Skin irritation and skin corrosivity; 
(4) Mucous membrane irritation (eye irritation); 
(5) Skin sensitisation; 
(6) Dermal/percutaneous absorption; 
(7) Repeated dose toxicity (nor mally 28- or 90-day studies);29  
(8) Mutagenicity/genotoxicity; 
(9) Carcinogenicity; 
(10) Reproduction toxicity; 
(11) Toxicokinetics (ADME studies); 
(12) Photo-induced toxicity; 
For the appropriate endpoints, the most relevant con centrations or No Observed Adverse Effect Levels 
(NOAEL) or Lowest Observed Advers e Effect Levels (LOAEL) should be identified for further use in the 
risk characterisation process. 
Additional information regarding endpoint specific data and their interpretation can be found in the endpoint 
specific guidance30 prepared by the European  Chemical Agency (ECHA) for the implementation of 
                                                 
27 Cfr. SCCS Notes of Guidance, Section 3-6 Basic Requirements for Cosmetic Substances Present in Finished 
Cosmetic Products (which are to be evaluated by individual safety assessors). 
28 The SCCS Notes of Guidance clearly  address this issue in para. 3-6.1 General toxicological requirements. 
29 According to the SCCS’s Notes of Gu idance (para. 3-4.5), priority should be given to the NOAEL as regards 
sub-chronic toxicity (90 day study). Only if such values  are not available should results relating to sub-acute 
toxicity (28-day study) be used. 
30 ECHA, Guidance on information requirements and ch emical safety assessment - Chapter R.7a: Endpoint 
specific guidance, May 2008.   
EN 18   EN Regulation (EC) No 1907/200631 on Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH).  
For some cosmetic ingredients e.g. of mineral, animal, botanical and biotechnological origin (see also  
Substances of Unknown or Variable composition, Comple x reaction products or Biological materials or 
‘UVCB substances’ under REACH),32 their identification should carefully address source, process, 
organisms involved, etc., in order to evaluate their toxicological profile. 
If certain hazards cannot be sufficiently addressed, or if  doubts remain regarding the robustness of the data, 
additional uncertainty factors may be introduced or  additional data may need to be generated. 
3.8.3.  Consideration of all the signi ficant routes of absorption 
Dermal, oral and inhalation routes of exposure are potentially relevant  for human exposure to cosmetic 
products. It is essential to calculate the systemic expos ure in order to compare it with the relevant NOAEL. 
The ratio between these two is defined as the margin of safety, which is an indicator of whether the product 
can be considered safe or not (see also section 3.8.4 and following). 
Absorption is linked to the bioavailab ility of a substance, and is essential fo r calculating the margin of safety. 
Systemic exposure can be calculated as: 
Systemic exposure dose33 (SED) = External exposure x absorption 
Absorption can occur through several external routes: dermal, oral and inhalation.  
If the intended exposure for the cosmetic product is not in  line with the route of exposure in the safety data, 
route-to-route extrapolation should be considered. 
(a) Absorption after  dermal exposure  
The dermal absorption34 of a substance in a product is dependent on both intrinsic factors 
(e.g. LogPow, molecular wei ght) and its behaviour in the vehicle. Dermal in vivo human 
absorption of a substance can be estim ated using the data from existing in vivo  animal 
studies and in vitro  studies on animal and human ski n. When no measurement data are 
available and no absorption rate can be de termined using a scientifically valid in silico  
method or default absorption rates,  a worst case value of 100   % should be used for 
calculation of the systemic exposure.35 In case MW > 500 Da and log Pow is smaller than -
1 or higher than 4, a value of 10 % de rmal absorption can be considered.  
(b) Absorption after oral exposure  
                                                 
31 OJ L 396, 30.12.2006, p. 1. 
32 Cfr. ECHA, Guidance for identification and naming of substances under REACH and CLP, November 2011, 
p. 29. http://echa.europa.eu/documents/10162/17235/substance_id_en.pdf 
33 I.e. ‘the systemically available dose th at passes the relevant physical barriers (gastro-intestinal, skin or lung 
structures) and becomes available in the blood stream for subsequent distribution to tissues and organs’, ref. M. 
Pauwels, V. Rogiers, p. 262. 
34 Basic criteria for the in vitro a ssessment of dermal absorption of co smetic ingredients (SCCS/1358/10). 
35 SCCS Notes of Guidance, para 3-7.2, p. 49.  
EN 19   EN When a reasonably foreseeable use can entail ingestion, the oral route should be included 
in the exposure scenarios .  
(c) Absorption after inhalation  
For all substances used in spray applications  and some powders, the inhalation route is to 
be taken into consideration in determining the systemic exposure.  
In addition, there may also be a possibility of secondary inhalation exposure where cosmetic products 
contain volatile substances which can be inha led unintentionally in the case of direct use,  e.g. toluene in nail 
polish, various substances cont ained in nail modelling gels,  etc. 
3.8.4.  Consideration of systemic effects and calculation of the margin of safety 
The safety assessment of a product for systemic toxicity is highly dependent on data  on each substance, since 
there will be no data on systemic toxic ity for the finished cosmetic product. 
Risk characterisation usually involves an expert evalua tion of the potential non-quan tifiable adverse effects, 
followed by calculation of an uncertainty factor or margin of safety.36 This calculation depends on the 
systemic exposure to the substance and its toxicological parameters. 
In accordance with Point 8 part A of Annex I to Regulation (EC) No 1223/2009, systemic effects and margin 
of safety are to be considered in Part A of the safet y report. As they are mandatory, the omission of these 
steps is to be duly justified. An example where this could apply would be the presence of a substance in the 
cosmetic product at a low level, with the expected (w orst case) exposure levels being below the appropriate 
threshold of toxicological concern (TTC) values37. Another example could be the inclusion of food materials 
for which a much higher innocuous ingestion level is known. 
When the requirement to calculate the margin of safet y cannot be met, a different way of expressing the safe 
dose for each substance may be appropriate, where ju stified. When a NOAEL is not available, other 
reference toxicology values such as No Observed Ef fect Level (NOEL), LOAEL, Lowest Observed Effect 
Level (LOEL), can be used to calculate the margin of safety; Benchmark Dose (BMD) or Virtually Safe 
Dose (VSD), used to qualify and quan tify a risk in other fields, may be  used in the context of cosmetic 
products safety assessment, provided a relationship with exposure is established, by comparing the exposure 
from cosmetics and these reference doses. 
Otherwise, the safety of a particular substance in a particular product cannot be demonstrated. 
According to the procedures described  in the SCCS Notes of Guidance,38 the margin of safety (MoS) for a 
specific route of exposure can be calculated using the following formula: 
 
MoS = Systemic No-Observed-Adverse-Effect Le vel (NOAEL) / Systemic Exposure Dose (SED) 
                                                 
36 M. Pauwels, V. Rogiers, p. 262. 
37 SCCS, SCHER and SCENIHR, Opinion on Use of the Threshold of Toxicological Concern (TTC) Approach 
for Human Safety Assessment of Chemical Substances  with focus on Cosmetics and Consumer Products, 
SCCP/1171/08. 
38 SCCS Note of Guidance, para 3-7, p. 46.  
EN 20   EN  
where the Systemic Exposure Dose (SED) is obtained by combining the external exposure (mg/kg bw/day) 
with the absorption rate (typically expressed in % or µg/cm2), frequency and retention factors. 
It is generally accepted that the margin of safety should be  at least 100 to declare a substance safe for use in a 
finished product. 
In the case of route-to-route extrapolation, the respec tive bioavailability via each route should ideally be 
taken into consideration. The assumption of 100 % or al bioavailability might overestimate the systemic 
exposure in a toxicity study via the oral route. Theref ore, in the absence of data, it should be assumed that 
not more than 50 % of an orally administered dose is systemically available. If there is evidence to suggest 
poor oral bioavailability, for example if the substan ce is a poorly soluble particulate, it may be more 
appropriate to assume that only 10 % of the administered dose is systemically available39. Whenever oral 
absorption data are available, these should be included in the calculations.  
The NOAEL chosen for calculating the margin of safet y is taken from long-term repeated dose toxicity 
studies (sub-acute, sub-chronic, and/or chronic toxicity  tests, carcinogenesis test s, teratogenesis tests, 
reproduction toxicity, etc.). 
The value used will be the lowest NOAEL obtained by  the most pertinent study with respect to the 
conditions of use of the substan ce, to species sensitivity, etc. 
From the complete toxicological profile, a NOAEL should be determined for the systemic effects. In general, 
the lowest relevant NOAEL of the most relevant endpoint is selected for calculating the margin of safety. 
The calculation of the margin of safety based only on Me dian Lethal Dose (LD50) data derived from single 
dose tests (instead of a NOAEL from at least sub-acu te tests) cannot be used to justify safe use. 
When the absence of bioavailability can  be clearly demonstrated, the calculation of the margin of safety is 
not necessary. In these cases the possible local effects on skin or mucous membranes should still be 
considered. 
3.8.5.  Impact on the toxicological prof ile of certain characteristic s of the substances or the 
product 
(a) Particle size  
The particle size and its distribution curve can have an influence on the toxicity of a 
substance. When it cannot be excluded that they have an impact on the safety of the 
finished product, they should be included am ong its physico-chemical characteristics, and 
be taken into account during the safety assessm ent. The most recent scientific opinions on 
the subject should be followed (SCENIHR, SCCS)40. 
                                                 
39 IGHRC, Guidelines on route-to-route extrapolation of t oxicity data when assessing health risks of chemicals. 
The Interdepartmental Group on Health Risks from Chemicals (2006),  
http://www.silsoe.cranfield.a c.uk/ieh/ighrc/ighrc.html  
40 See for example: SCCS (Scientific  Committee on Consumer Safety), Guidance on safety assessment of 
nanomaterials in cosmetics, SCCS/1484/12; SC ENIHR (Scientific Committee on Emerging and Newly 
  
EN 21   EN (b) Impurities in the substances and raw materials  
Impurities can have a major impact on the overall toxicity of any substance. It is important 
to check the impurities profile of a substance to avoid, or at least assess, any additional risk from the impurities. In the abse nce of safety data from toxicological studies, the threshold 
of toxicological  concern (TTC)
41 might be a useful tool for assessing the safety of certain 
impurities. 
When toxicological studies are used to characte rise the toxicological profile of a substance, 
the purity and impurities pr ofile of the substance used in the toxicological studies should 
be described. If the batches actually used in the formulation of the cosmetic product do not 
have a comparable impurity profile, the differences need to be assessed. 
3.8.6.  Use of read-across should be substantiated and justified 
Several approaches exist for the read-a cross technique. The use of this t echnique should be substantiated and 
justified. 
3.8.7.  Identification of the s ources of information 
The determination of the toxicological profile requir es a minimum of information on the substance to be 
evaluated. 
This information can be collected from toxicological studies. If data from human experience exist, they 
should be taken into account. 
Other tools such as quantitative structure-activity relationship (QSAR) or bridging approaches are only 
estimations of toxicity, and the weight of ev idence should be substan tiated and justified. 
The following sources of data shoul d be taken into consideration: 
(a) Safety and quality data which may be on file  with the respective suppliers of the raw 
materials in the formulation, and whic h the supplier shoul d share with the 
manufacturer of the cosmetic product. This  is an important element in considering 
the availability of relevant data to demonstrate the safety of each cosmetic ingredient in the final product formulation; 
(b) If an opinion of the SCCS exists, the NOAEL used in the opinion should be used. 
The safety assessor should ta ke into account the most up- to-date scientific opinion; 
(c) If an opinion of another authoritative scientific committee exists, the NOAEL used in 
the opinion could be used, provided th at the conclusions and limitations are 
applicable to the expected use (the use ta ken into account for ca lculating the margin 
of safety can be different). The safety as sessor should take into account the most up-
to-date scientific opinion; 
                                                                                                                                                                 
 
Identified Health Risks), Opinion on the scientific basis for the definition of the term “nanomaterial”, 8 
December 2010. 
41 R. Kroes, A. G. Renwick, V. Feron,  C. L. Galli, M. Gibney, H. Greim, R.  H. Guy, J. C. Lhuguenot, J. J. M. 
van de Sandt, Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic 
ingredients , Food and Chemical Toxicology 45 (2007), pp. 2533–2562.  
EN 22   EN (d) If no scientific opinion exists, it will be necessary to provide information to 
characterise the toxicological  profile of each substance. The data can be obtained 
from several databases or literature (see Appendix I);42 
(e) Classification under Regulation (EC) No 1272/ 2008 of the European Parliament and 
of the Council;43  
(f) Studies performed or obtained by the manufacturer of the product; 
(g) In silico  prediction (QSAR); 
(h) Bridging approach; 
(i) Assessments of non-cosmetic uses of th e substance (foodstuffs, food additive, food 
contact materials, biocides, Registration,  Evaluation, Authorisa tion and Restriction 
of Chemicals (REACH)…) may also be used in order to complete information on the 
toxicological profile of the substance. 
(j) When available, the CSR (Chemical Safety  Report) or the robust study summaries 
submitted pursuant to Regulation (EC) No 1907/2006 (REACH).   
A number of substances and/or mixtures have not been studied sufficiently to determine all the pertinent 
toxicological parameters. For these missing parameters, or  where the risk characterisation is based on an 
approach using toxico logical data acquired for other substances (fo r example similar structures) or for uses 
other than cosmetics (food, bi ocides, pharmaceutical products, etc.), justifications should be included in the 
report. 
3.9. Undesirable effects and serious undesirable effects 
The aim of that section of the cosmetic product safety report is to monitor the safety of the 
product after it has been placed on the market  and to take corrective action, where necessary. 
To this end, the responsible person (in collabora tion with the distributors) is required to set 
up a system to collect, document, establish the ca usality of and manage the undesirable effects 
caused by the product after its use in the Union44. When the undesirable effects are serious, 
the responsible person (and the distributors) are to notify the competent authority of the 
Member State where the effects occurred45. 
Information on undesirable effects and serious undesirable effects is to be included in the 
cosmetic product safety report, kept up-to-date and made available to the safety assessor, who 
may revise their assessment or take the information into a ccount when assessing similar 
products. 
                                                 
42 Several publicly available databases containing toxicological data on substances used in cosmetics exist, and 
are listed in Appendix I to this Guideline. 
43 OJ L 353, 31.12.2008, p. 1, and ECHA’s registratio n website: http://apps.echa.euro pa.eu/registered/registered-
sub.aspx. 
44 This is a consequence of the requirement of Article 23 of Regulation (EC) No 1223/2009, which establishes 
the obligation for responsible persons to notify serious undesirable effects to competent authorities in the EU Member States. 
45 Article 23 of Regulation (EC) No 1223/2009.  
EN 23   EN The cosmetic product safety report is to include all the available data , including statistical data, on the 
undesirable effects and serious undesirable effects of th e cosmetic product or, where relevant, other cosmetic 
products. 
In particular, information on undesirable effects  which, according to the causality assessment, are found to 
be very likely, likely, not clearly attributable  or unlikely to be attributable46 to the cosmetic product in 
question are to be included in the safety report. 
Data on undesirable effects may be included in this part of the safety report in the form of statistical data 
such as the number and type of undesirable effects per year. 
Information on serious undesirable effects  which, according to the causa lity assessment, are found to be 
very likely, likely, not clearly attributable or unlikely to be attributable  to the cosmetic product in question 
are to be included in the safety report in accordance with  section 9 of Part A of Annex I to Regulation (EC) 
No 1223/2009, and notified to the national competent au thorities, in accordance with Article 23 of the same 
Regulation47. The notification forms sent to the competent aut horities are therefore to be attached to the 
cosmetic product safety report .  
The responsible person’s reaction to a nd handling of the reported serious und esirable effects is to be stated. 
The corrective and preventive measures taken, if any, should be described. 
The information on undesirable effects is to be kept  up-to-date and regularly made available to the safety 
assessor48, who may consider it necessary to revise the safety assessment, suggest improvements to the 
formulation or use the information to estab lish the safety assessment for similar products. 
Additional cosmetovigilance data, such as serious undesi rable effects of a non-intended use may also provide 
helpful information that the safety assessor should consider. 
3.10. Information on the cosmetic product 
That section of the cosmetic product safety report allows the inclusion of any additional 
information which is not covered under the other headings of Part A of Annex I to Regulation 
(EC) No 1223/2009, but is considered relevant in order to carry out the safety assessment of 
the product. 
This section of the cosmetic product safety report  should contain other rele vant information, either 
relating to the product or similar formulations, such as existing studies on human volunteers, or relating to 
specific substances, such as the duly confirmed and subs tantiated findings of risk assessments carried out in 
other relevant areas. 
This section could be used to refer to information on substances or mixtures also used in other kinds of 
products, such as food and pharmaceuticals. 
                                                 
46 For undesirable effects that are very likely or likely to be attributable to the cosmetic product, Article 21 of 
Regulation (EC) No 1223/200 9, ‘Access to information fo r the public’, applies. 
47 European Commission, Serious Undesirable Effects (SUE) Reporting Guidelines, 
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue_reporting_guidelines_en.pdf  
48 This is an obligation of the responsible person according to article 10(1)(c) of Regulation (EC) No 1223/2009.  
EN 24   EN 4. PART B OF ANNEX I TO REGULATION (EC)  NO 1223/2009  — COSMETIC PRODUCT 
SAFETY ASSESSMENT  
Part B of the report is the actual assessment  of the safety of the product. In their 
reasoning, the safety assessor is required to ta ke into account all th e hazards identified 
for the product and the exposure to it. 
Part B of the cosmetic product safety  report comprises: 
(1) The assessment conclusion; 
(2) The labelled warnings an d instructions of use; 
(3) The reasoning; 
(4) The credentials of the safety a ssessor and their final approval. 
4.1. Assessment conclusion 
The assessment conclusion is  a statement on the safety of the cosmetic product in 
relation to the safety requirement of Ar ticle 3 of Regulation (EC) No 1223/2009. 
The conclusion should state whether the product is safe, safe with restrictions or not safe for human 
health when used under normal or reas onably foreseeable conditions of use. 
The legal framework for the assessm ent should be explicitly mentioned,  in particular Regulation (EC) 
No 1223/2009 on cosmetic products (Official Journal L 342, 22 December 2009, pp. 59–209). 
If the product has been assessed as not safe, it cannot  be considered to comply with Regulation (EC) 
No 1223/2009 and therefore is not to be placed on the market. 
4.2. Labelled warnings and instructions of use 
The aim of that section of the cosmetic pro duct safety report is to explicitly list the 
particular precautions to be observed in use,  including at least those listed in Annexes 
III to VI to Regulation (EC) No 1223/2009 and any special precautionary information on 
cosmetic products for professional use, which should appear on the labelling. 
In accordance with Annex I to Regulation (EC) No  1223/2009, this section is to be a statement 
regarding the need to label any particular warnings and instructions of use in accordance with Article 
19(1)(d) of Regulation (EC) No 1223/2009. 
It is the task of the safety assessor to determine which warnings or inst ructions of use, in addition to 
those listed in Annexes III to VI, need to be la belled to ensure the safe use of the product. 
The safety assessor should decide what is to app ear on the labelling on a case-by-case basis, taking 
into account the legal obligations deriving from Ar ticle 19 and the Annexes to Regulation (EC) No  
EN 25   EN 1223/2009 and, where relevant, instruments such as Commission Recommendation 2006/647/EC49 
and other guidelines published by the Commission such as  those on the ‘period of time after opening’ 
labelling50 and the labelling of ingredients under Directive 76/768/EEC51. 
4.3. Reasoning 
The reasoning is the core of the safety assessme nt, as its aim is to clearly and accurately 
explain how the safety assessor reaches his or her conclusions on the safety of the 
cosmetic product from the data gathered und er Part A of Annex I to Regulation (EC) 
No 1223/2009. 
The safety assessment is to be performed on  a case-by-case basis for each individual 
cosmetic product and be the result of an ex pert evaluation of the available data. The 
safety assessor should ensure that all the information (s)he needs to carry out a safety 
assessment is available; (s)he should check the relevance of the data provided on the 
product to be assessed; and (s)he  should ju stify the absence of data required under Part 
A, when (s)he considers they are not relevant or necessary. 
In order to draw conclusions on the safety of  a cosmetic product, the safety assessor is 
required to evaluate the safety of the indivi dual substances or mixtures present in the 
formulation and the safety of the finished pr oduct. His/her conclusi ons are to be based 
on a body of evidence showin g that, for all the hazards id entified, the product can be 
considered safe in terms of human health. 
The safety assessor may accept, reject, or accept under specific conditions the 
formulation under consideration. A product th at does not comply with Regulation 
1223/2009 is to be rejected and not marketed. 
The reasoning for the safety assessment sets out the c onsiderations that lead the safety assessor, based 
on all available safety-related information, to an overall conclusion on the safety of a product. 
In their reasoning, the safety assessor is required to ta ke into account all the hazards identified, the 
intended and reasonably foreseeable exposure cond itions of the individual substances or mixtures 
present in the formulation and of the finished cosmetic product. 
Analysis and evaluation of the validity/reliability of all existing information is the task of the safety 
assessor. By conducting this analysis, the safety assessor  is able to decide wh ether the available data 
are sufficient to perform a safety assessment or whet her additional data need to be obtained on an 
individual substance or the finished cosmetic product. 
The reasoning is based on the data compiled in Part A of the cosmetic product safety report  and 
takes into account the safety evaluation of substan ces and mixtures, carried out by the Scientific 
Committee for Consumer Safety when the substances appear in the Annexes to Regulation (EC) No 
                                                 
49 OJ L 265, 26.09.2006, p. 39. 
50 Available on 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/labelling/index_en.htm . 
51 Available on http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_labelling200802_en.pdf .  
EN 26   EN 1223/2009, by other competent scientific committees or  panels, or by the safety assessor him/herself, 
and the safety evaluation of the cosmetic product. 
4.3.1.  Safety Evaluation of Subst ances and /or Mixtures 
The safety evaluation of substances and/or mixtures consists of three main steps: 
(1) hazard characterisation of substances and mixtures; 
(2) assessment of the local and systemic exposure (considering absorption data); 
(3) risk assessment of systemic effects (cal culation of margin of  safety) and risk 
assessment of local effects (such as  skin allergy, skin irritation). 
For fragrance and flavour compounds, where informat ion on their composition is confidential, a safety 
assessment may be provided to the responsible pe rson for the finished cosmetic product by the 
manufacturer of that mixture. Taking into account th e concentration in the final cosmetic product and 
its exposure pattern, the safety assessment of the fragrance and flavour compound should be prepared 
following the principles described in Annex I to Regulation (EC) No 1223/ 2009 and these guidelines. 
An appropriate document demonstrating the safet y of the fragrance or flavour compound should be 
provided by the supplier to the responsible person for the finished cosmetic product. 
4.3.2.  Safety Evaluation of the Cosmetic Product 
The safety evaluation of the cosmetic product covers three main aspects: 
(1) Summary of the risk assessment based on the local and systemic effects of all 
individual substances/mixtures52; 
(2) Additional assessment of the safety of the formulated product, which cannot be 
assessed by assessing the substances/mixtures separately. This could for instance be the formulation’s skin co mpatibility, assessment of possible 
combination effects, such as one ingredient that can increase the absorption rate of another ingredient, possible eff ects that could arise from interaction 
with packaging material, or possible eff ects due to chemical reactions between 
the individual substances/mixtures in the formulated product
53; 
(3) Other factors that influence the safety assessment, such as stability, 
microbiological quality, packaging, and labelling, including use instructions 
and precautions for use. 
The specific assessment for cosmetic products inte nded for use on children under the age of three 
which is required in accordance with Regulation (EC) No 1223/2009 should take into account the 
specific recommendations in th e SCCS Notes of Guidance.54  
                                                 
52 For products in the same range, where the only di fference among different products is the colouring 
agent, and that has no impact on safety, e.g. for lipsticks or other colour make-up, a combined product 
safety report may be considered (so-called om nibus procedure), but is to be justified. 
53 SCCS, SCHER, SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012 
http://ec.europa.eu/health/scien tific_committees/environmental_risks/docs/scher_o_155.pdf 
54 SCCS Notes of Guidance, para 3-7.3, p. 51.  
EN 27   EN In the specific assessment require d in accordance with Regulation (EC) No 1223/2009 for cosmetic 
products intended exclusively for use in external in timate hygiene, the particular characteristics of the 
application site also are to be taken into account. 
The safety assessor may accept, re ject, or accept under specific conditions the formulation under 
consideration. A product that does not comply with  Regulation (EC) No 1223/2009 is to be rejected 
and is not be marketed. Recommendations by the safety assessor regarding the safe use of the product 
should be followed. 
In order to ensure that the cosmetic product sa fety report is kept up to  date as required by 
Article 10(1)(c) of Re gulation (EC) No 1223/2009,  the safety of the finished product should be 
reassessed regularly. 
When changes in the legal requirements occur (e.g. restrictions of one of the substances included in 
the formulation), it should be checked, amongst othe rs (e.g. labelling), whether the formulation still 
complies with the law, and the safety assessment s hould be reviewed and, if necessary, updated.  
The safety assessment should also be reviewed and, if  necessary, updated, where one or more of the 
following circumstances apply: 
(a) new scientific findings and toxicological  data on the substances are available 
which could modify the result of  the existing safety assessment; 
(b) changes occurring in the formulation or  specifications of raw materials; 
(c) changes occurring in th e conditions of use; 
(d) a rising trend in terms of  the nature, severity a nd frequency of undesirable 
effects, both under reasonably foreseeable conditions of use and in the case of 
misuse55 
 
Structures and processes should be established to ensure that the information relevant for the update of 
the cosmetic product safety report is efficiently exchanged between the r esponsible person and the 
safety assessor, and that the safety assessor is in a position to intervene where an update is necessary. 
4.4. Assessor’s credentials and approval of Part B 
The safety assessor is to be a professional with the necessary knowledge and expertise to 
draw up an accurate safety a ssessment, as indicated by th e qualification requirements in 
Article 10(2) of Regulation (EC) No 1223/ 2009. That section of the cosmetic product 
safety report aims at ensuri ng that this requirement is met and that the necessary 
evidence is provided. 
That section of the safety report is required to list the name and address of the safety assessor and to be 
dated and signed. 
                                                 
55 European Commission, Serious Undesirable Effects (SUE) Reporting Guidelines, 
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/sue_reporting_guidelines_en.pdf.  
EN 28   EN The result of the safety assessment is to be signed sta ting the date of preparation or be issued based on 
an electronic release establishing a clear relationship between the assessor, the formulation and the 
date of assessment. The electronic version should be protected from abuse by unauthorised persons. 
In accordance with Article 10(2) of Regulation (E C) No 1223/2009, the safety assessor is required to 
be ‘a person in possession of a diploma or other evidence of formal qual ifications awarded on 
completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine 
or a similar discipline or a course recognised as equivalent by a Member State’. 
A person who has obtained qualifications in a third country may act as a safety assessor if they have 
completed ‘a course recognised as equivalent [to a univers ity course of theoretical and practical study 
in pharmacy, toxicology, medicine or a similar discipline] by a Member State’ . 
Proof is to be provided of the safety assessor’s qua lification (i.e. copy of the diploma and, where 
needed, proof of equivalence) laid down in Article 10 of Regulation (EC) No 1223/2009.  
EN 29   EN References  
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mixtures. Atlanta, GA: ATSDR, U.S. Depa rtment of Health and Human Services, 
Public Health Service. EFSA (2008) EFSA-Q-2006-160. 
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Sheet to Assess the Risks for the Consumer, Updated version for ConsExpo 4, RIVM report 320104001/2006 (http://www.rivm.nl/b ibliotheek/rapporten/320104001.pdf). 
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EN 30   EN • Loretz L.J., Api A.M., Babcock L., Barraj L.M., Burdick J., Cater K.C., Jarrett G., 
Mann S., Pan Y.H., Re T.A., Renskers K. J., Scrafford C.G., Exposure data for 
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Toxicol. 2008 May; 46(5):1516-24, Epub 2007 Dec 23. 
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(2010), pp. 260-274. 
• SCCS (Scientific Committee on Consumer Safety), Guidance on safety assessment of 
nanomaterials in cosmetics, SCCS/1484/12. 
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EN 31   EN Appendix I – Known Databases Containing Toxicol ogical Data on Substances Used in Cosmetics  
ChemIDPlus Light — http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp  
ChemIDPlus Advanced — http://chem.sis.nlm.nih.gov/chemidplus/  
COLIPA Recommendations — http://www.colipa.eu/publications-c olipa-the-european-cosmetic-
cosmetics-association/recommendations.html  
IPCS Inchem — http://www.inchem.org/pages/jecfa.html  
PubMed — http://www.ncbi.nlm.nih.gov/pubmed  
ToxNet — http://toxnet.nlm.nih.gov/