Transcription
COSMETICS EUROPEADVISORY DOCUMENTINFORMATION EXCHANGE ONCOSMETIC PACKAGING MATERIALSALONG THE VALUE CHAIN IN THECONTEXT OF THE EU COSMETICSREGULATION EC 1223/200913 June 2019
Aim and Scope of this document:This document identifies a set of useful information from packaging/material suppliers thatsupports the assessment of the impact of the packaging on the safety of the cosmetic productcontained therein.There is no legal obligation that this information has to be collected by a cosmetic manufacturerby using this document. It is possible to apply other approaches, provided that they result innecessary, relevant information being available to the cosmetic product safety assessor.The document concerns the exchange of information. It does not provide safety assessmentmethodologies for integrating such information into the cosmetic product safety assessment. Thisremains fully in the role of the cosmetic product safety assessor.At the time of publication (June 2019), the principles described in this document have beenthoroughly tested in a number of pilot studies, involving actors from all steps in the packaging /material supply chain. However, given the complexity and diversity of the supply chain, theapproach cannot (yet) be considered as widespread industry practice. Implementationthroughout the supply chain will take place over time and the document itself will evolve with thepractical experience gained.1
Table of contentsIntroduction3Regulatory contextBackground and challenges regardingcosmetic packagingGeneral approachMethodologyChapter A – Stating compliance with food contact legislation/ standards9Assessing MigrationChapter B - If food contact compliance cannot be stated11Chapter C - Addressing substances of concern to cosmetic safety assessors12ANNEX 1 : Methodology : Decision Tree15ANNEX 2 : Useful EU and non-EU reference documents16ANNEX 3 : TTC concept and Cramer Classification19ANNEX 4 : Glossary / Definitions21ANNEX 5 : Template of Packaging Supplier Statement23ANNEX 6 : Application of food contact material compliance informationto cosmetics packaging27APPENDIX 1 Guidance List of Disclosable Substances302
IntroductionRegulatory contextIn accordance with the EU Cosmetics Regulation (EC) No. 1223/2009, a cosmetic product madeavailable on the market must be safe for human health when used under normal or reasonablyforeseeable conditions of use. In order to meet this requirement, the person responsible forplacing the product on the market must carry out a safety assessment, based on the intendeduse of the cosmetic product and the anticipated exposure to the individual ingredients:Article 10 : In order to demonstrate that a cosmetic product complies with Article 3 (safetyrequirement), the responsible person shall, prior to placing a cosmetic product on the market,ensure that the cosmetic product has undergone a safety assessment on the basis of the relevantinformation and that a cosmetic product safety report is set up in accordance with Annex I. Annex I of the Cosmetics Regulation describes the information that needs to be considered FORthe Cosmetic Product Safety Report. Section 4 provides details with regard to impurities, traces,and information about the packaging material : The purity of the substances and mixturesIn the case of traces of prohibited substances, evidence for their technical unavoidability.The relevant characteristics of packaging material, in particular purity and stability.Commission Implementing Decision 2013/674/EU establishes guidelines on the practicalapplication of the above requirements and, in its Annex provides further guidance with regard tothe information about the packaging material and the potential release of substances from thepackaging:Section 3.4 Packaging material means the container (or primary packaging) that is in directcontact with the formulation. The relevant characteristics of packaging materials in direct contactwith the final product are important for the safety of the cosmetic product. Reference toRegulation (EC) No 1935/2004 of the European Parliament and of the Council could be useful.Experience with similar formulation/packaging combinations already on the market providesuseful indications. Materials that have been developed for food packaging have often already beentested, so relevant information on stability and migration may be available. Additional testing maynot 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 theexternal environment may have an impact on the safety of the finished product, due to thefollowing 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 packaging materials in direct contact with theproduct should allow an estimation of potential risks. Relevant characteristics could include, forexample, the following:(a) composition of the packaging material, including technical substances such asadditives;(b) technically unavoidable impurities;(c) possible migration from the packaging.3
This information only indicates the hazard. It is up to the safety assessor to evaluate the risk.Studies on interactions/suitability between formulation and packaging allow testing of thepotential migration of small amounts of substances from the primary packaging material to theproduct. 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 onknowledge of the formulation and primary packaging materials and experienced expert judgment.If migration is dependent on storage conditions, the correct conditions should be indicated on theproduct labelling. If the formulation is sensitive to light or air, and would degrade in a way thatimpacts product safety or product efficacy, appropriate packaging should be used.Consequently, documentation provided by the packaging supplier is an important building blockfor the legally required safety assessment of the final cosmetic product by the responsibleperson’s safety assessor. In the absence of detailed regulatory requirements on the informationexchange along the value chain, a number of industry associations, representing the value chainof cosmetic packaging 1, worked out a common understanding of the relevant and appropriateinformation on packaging materials to be provided to the cosmetic product safety assessor.The scope of the resulting document extends to the following types of materials used in themanufacturing of cosmetic packaging: plastics, adhesives, metals, alloys, paper, board, printinginks, varnishes, rubber, silicones, glass and ceramics.The document aims at identifying which information regarding the packaging is relevant forconducting the safety assessment of the cosmetic product, where the main concern is thepossible migration of substances from the packaging into the cosmetics formulation. It presentsa common sense, harmonised approach for the exchange of information within the value chain.This information supports a safety assessor deliberation and conclusion if a packaging material /item has an impact on the safety of the cosmetic formulation. However, the document does notprovide detailed methodology on how to integrate this information into the cosmetic productsafety assessment.The document does also not deal with technical performance, quality / stability issues arisingfrom the use of a specific packaging for a specific cosmetic formulation. It is obviously vital inthe product development process to assess compatibility between the formulation and thepackaging, but this is not primarily a consumer safety issue and hence not dealt with in thispaper.FLEXIBLE PACKAGING EUROPE, FEBEA, COSMETICSEUROPE, ELIPSO, IKW, EUROPEAN TUBEMANUFACTURERS ASSOCIATION, EUROPEAN METAL PACKAGING, EUROPEAN COUNCIL OF PAINTPRINTING INK AND ARTIST COLOURS INDUSTRY, INDUSTRIEVEREINIGUNGKUNSTSTOFFVERPACKUNGEN, UNIONPLAST – FEDERAZIONE GOMMA PLASTICA, COSMETICAITALIA, EUROPEAN PLASTICS CONVERTERS, PLASTICS EUROPE, CEFIC FCA14
Background and challenges regarding cosmetic products packagingThe development of a packaging for a cosmetics product needs to take account of a number offactors. It should meet:a) The required technical performance of the pack, e.g. product protection, compatibilitywith product, filling line performance.b) The requirements of the Cosmetics Regulation for safety assessment (i.e. the packagingmust not negatively impact the safety of the cosmetic formulation)c) Requirements regarding REACH, the Packaging and Packaging Waste Directive 94/62/ECand other legislationRegarding a potential impact of the packaging on the safety of the cosmetic product, the mainconcern lies with the potential migration of substances from the packaging into the cosmeticformulation. Depending on the material combination used, such migration may be unavoidable– and indeed, the Cosmetics Regulation acknowledges in Article 17 that: “The non-intendedpresence of a small quantity of a prohibited substance, stemming from migration frompackaging, which is technically unavoidable in good manufacturing practice, shall be permittedprovided that such presence is in conformity with Article 3” (i.e. the requirement for products tobe safe). It is therefore important that the cosmetic product safety assessor receives relevantinformation on the composition and migration behavior of the packaging material in order to beaware if any significant migration occurs and assess whether it would impact the cosmeticformulation safety.Packaging materials are not simple chemical substances or mixtures. The packaging of acosmetics product may consist of a number of different components, some in direct contact withthe cosmetic formulation, others not (or only for a brief time during use). Each component initself may be made from a number of different raw materials. These raw materials maythemselves have multi stage supply chains.While the broad chemical nature of these components may be known, the details of theindividual chemical substances and additives that are used to make them are often trade secrets.Hence an apparently straightforward enquiry of “what chemical substances does your packagingcontain?” is often difficult to answer, both due to the complexity of the supply chain and due tojustified concerns of suppliers over sharing business-sensitive information. A full breakdown ofcompositional detail would create a disproportionate administrative burden along the supplychain without being necessary for an adequate safety assessment by the cosmetic product safetyassessor. There is therefore a need for a pragmatic approach that meets the need of the cosmeticresponsible person and his safety assessor for accurate relevant information, while avoiding aflood of unnecessary detail on the composition of every packaging component.The following approach was developed, which aims to provide the necessary level of information,while preserving the know-how of every supply chain member. It builds on the fact that a wellestablished process exists for providing information along the supply chain of food packagingmaterials.5
General approach for the information exchangeThe EU Framework Regulation for food contact materials (Regulation (EC) No 1935/2004) setsout the general principles of safety and inertness for all Food Contact Materials. It requires inparticular that materials are manufactured according to Good Manufacturing Practices and donot release their constituents into food at levels harmful to human health and provides rules forcompliance documentation and traceability. Moreover, additional EU as well as nationalmeasures exist for specific types of materials (e.g. plastics, ceramics, metals/alloys, etc.). Notethat other regions in the world have similar requirements/approaches to food packaging safety(see Annex 2).For the following reasons, the information generated under food packaging legislation can inprinciple also be used for the safety assessment of packaging used for cosmetic products (seeChapter A and Annex 6 for more details) : Physico-chemical similarities between many cosmetic formulations and typical foodmaterials Manufacturing standards based on Good Manufacturing Practices Safety assessment of the food packaging based on its composition and potentialmigration of substances into the food Similar worst-case ratio of packaging surface to packaging content between food andcosmeticsThus, it is possible in many instances that documented compliance with food packaginglegislation becomes the main information to the cosmetics product safety assessor. Additionally,some limited information on the presence of specific substances of concern under the CosmeticsRegulation remains necessary. However, a complete composition breakdown of all packagingconstituents would not be required,In the case where a packaging material complies with food packaging legislation of a non-EUcountry, it is still possible to apply a similar approach to the one developed here. It may benecessary, however, that the supplier provides the cosmetics product safety assessor withinformation on the specific requirements and standards that these third country food regulationsprescribe.The present approach can also be applied in case of partial non-compliance with the foodpackaging legislation or incomplete information on the compliance of the packaging with foodpackaging legislation. In this case, the guidance can be applied as such for those materials of thepackaging that are compliant, and additional information would be required on thosematerials/substances that create the non-compliance or uncertainty (see Chapter B).It has to be emphasised that this document does not aim to set a requirement orrecommendation that cosmetics packaging must be compliant with EU food contact legislation.Obviously, any packaging material / item that does not impact the safety of the cosmeticsformulation is acceptable. However, the logic of the present approach may be difficult toapply/not applicable and the supplier needs to discuss on a case-by-case basis with the cosmeticcompany to identify the necessary information that the latter needs for their safety assessment.6
MethodologyThe following methodology for information exchange can be applied throughout the supplychain, regardless of whether it concerns supply of a packaging raw material, bulk material, or apackaging component 2 or packaging item.Firstly, all specific items or materials (depending on what is supplied) should be described withtheir general chemical composition.Note that the safety assessment of a cosmetic product must ultimately consider the potentialimpact arising from the transfer of substances from the packaging into the cosmetic formulation.Therefore it is usually only necessary to provide information to the cosmetic safety assessor onthose components / materials used for the primary packaging (since the secondary packaging istypically not in contact with the cosmetic formulation). However, if the primary packaging doesnot provide a functional barrier, one should also consider the potential for transfer of substancesfrom the secondary packaging into the cosmetic formulation, whether by migration or by vapourphase transfer.Compliance with the requirements of the EU Chemicals Legislation and packaging/packagingwaste legislation is mandatory, including certain information that the suppliers need to provideto downstream users. It is useful to include also the following relevant regulatory information foreach material or component 3:REACH : It is mandatory to declare the presence of Candidate list Substances of Very HighConcern ble ) when present in acomponent at a quantity at or above 0.1% w/w (i.e. 1000 mg/kg) and to provide theidentity of such substances. (It is also useful to declare if such substances are not present).Heavy Metals : It is often required to confirm that the product is in compliance with thelimit of 100 ppm laid down in Packaging Waste Directive 94/62/EC for the sum ofconcentration levels of lead, cadmium, mercury and hexavalent chromium.Secondly, all those components / materials which are potentially capable of transferringchemical substances to the cosmetics formulation should be identified.Thirdly, having thus identified those packaging components / materials which can have apotential impact on the safety of the cosmetics product, adequate information needs to becommunicated about them to allow the cosmetic product safety assessor to evaluate theirimpact (if any) on the safety of the cosmetic formulation. The following chapters describe theactions recommended in this approach (see also the flowchart in Annex 1):Component: A part of the packaging system which can exist as a separate entity, either being assembled by thepackaging supplier or being incorporated into the final pack by the packer2Different component parts of the packaging are considered separately, in line with the CJEU position (Case C106/14).37
Chapter A.If possible, the supplier declares and documents compliance with foodcontact legislation/ standards.Chapter B.Where food contact compliance cannot be claimed, the supplier providesrelevant information for the safety evaluation of the packaging by othermeans.In either case :Chapter C.The supplier addresses substances that are of specific concern under to thecosmetic product safety assessor (i.e. banned or restricted under theCosmetic Regulation Annex II, Annex III and CMR substances as well assubstances classified as skin sensitisers).Annex 5 provides an example for reporting of the relevant information by the final packagingsupplier to the cosmetic responsible person.8
Chapter A – Stating compliance with food contact legislation/standardsThe Food Contact supply chain has developed a practical approach based on existing legislationwhich can be adapted for Cosmetics. The principle has been adopted that, in the majority ofcases, if the packaging is safe for a specific type of food, it should also be suitable for cosmeticsthat have similar physical chemical properties as this food (see Annex 6 for more details).For each component where this is possible, the supplier should therefore state and document compliance with the general requirements of EU Framework Regulation (EC) No1935/2004 on food contact materials compliance with the Good Manufacturing Practices (GMP Regulation (EC) N 2023/2006) compliance with requirements of EU or national legislation that are applicable for thespecific type of food material (see below) the types of food (food simulants) for which this statement of compliance is valid. Thisallows the cosmetic product safety assessor to determine whether the information onfood packaging safety is relevant for his specific cosmetic formulation.Compliance with the requirements of Regulation 1935/2004 Article 3 for a specific material typeis usually documented by demonstration of compliance with specific European legislation, withappropriate National legislation, with Council of Europe Resolutions, European standards or withcodes of practice, e.g. developed by Trade Associations. Such rules often feature: A general requirement that substances used in the manufacture of materials and articles“shall be of a technical quality and purity suitable for the intended and foreseeable use ofthe materials or articles”,Positive lists of substances that may be used to make the material,Limits for the use levels of a substance in a material or, more often, specific migrationlimits with regard to the transfer into the food which are based on a risk assessment ofthe substance carried out by EFSA or other official body,A risk assessment of unlisted or non-intentionally added substances (worst case riskassessment).A list of the main relevant legislative and other references can be found in Annex 2.Assessing MigrationAn important mechanism to ensure the safety of food contact materials is the use of migrationlimits. These limits specify the maximum amount of a substance allowed to migrate to food.An Overall Migration Limit (OML) is a limit for the migration into food of all substances together.It is a measure for the inertness of the material.'Specific Migration Limits' (SML) can be set in EU or national regulation on the basis of toxicitydata for specific substances9
For plastic food contact materials the rules for migration testing are clearly stipulated in theCommission Regulation EU 10/2011. (e.g. the OML is set at 60mg/kg food, or 10 mg/dm2 of thecontact material). For many other materials like paper & board, metals, rubbers or migration ofprinting inks through substrates, the rules for migration testing have been established in nationalregulations or in industry guidelines.Migration results to demonstrate compliance with these limits can be obtained in food itself, orin food simulants, or can originate from migration modelling or worst case assumptions (i.e.assuming that 100% of the substance would migrate into the food).Migration can also be estimated based on worst-case assumptions or conservative modelling.More detailed assessments and/or tests are only necessary when these assumptions proof to beoverly conservative. If compliance has been based on modelling or worst case calculation, thereis no need to further evaluate migration through testing.If compliance has been based on migration into food / food simulants, the cosmetics assessorneeds to decide whether the food/simulants and test conditions / assumptions are applicable tothe cosmetics formulation. Regulation (EU) No 10/2011 on plastic materials and articles defines5 food simulants representing the main food characteristics that are influencing migration (seeAnnex 6 for more information). Regarding food groups not specifically assigned to a foodsimulant, the Regulation encourages that expert judgement be used based on the similaritieswith other food groups to assign an appropriate simulant. For most cosmetic formulations, thephysical/chemical properties relevant for migration from the packaging correspond to theproperties of typical food stuff. Therefore, a similar expert judgement approach can be taken todecide whether information based on a particular food/simulant is applicable to the cosmeticformulation.Note that some formulations, e.g. alkali preparations such as some hair care products, cannot berepresented by existing recognised food simulants. If suitable simulants do not exist or ifmigration assessment using appropriate simulants mimicking the cosmetic product exceed OMLand/or SML values, the “safe for food, safe for cosmetics” argument cannot be used. Thepackaging material must then be assessed as if it were a non-food contact compliant structure.Information on migration that was established upstream in the supply chain can be transmittedand does not need re-established at all steps in the supply chain of the packaging item/material.10
Chapter B - If food contact compliance cannot be statedA Cosmetic packaging material might not be food contact compliant because of the presence ofa substance that is not authorised for food contact materials or used outside of restrictions setfor such use. Non-compliance could also be linked to the material not having been manufacturedaccording to GMP Regulation (EC) N 2023/2006. Such packaging may still be perfectly safe foruse in a cosmetic application after the performance of the safety assessment. References to otherstandards like e.g. pharmaceutical standards or food and feed additives might be helpful ingenerating useful support information.Firstly it is important to demonstrate that the cosmetic packaging is produced in a consistentway. ISO 9001 or any other equivalent quality system are appropriate.Secondly attention has to be paid to the non-authorised substance(s). It should be noted that thepresence of such substance(s) render the packaging non-compliant for food, but it does notnecessarily indicate that the packaging is less safe for cosmetics use than food law compliantpackaging. The approach under Chapter A can still be followed for all those components andmaterials that are food contact compliant. However, for those materials or components that arenot compliant, the supplier should inform the cosmetics product safety assessor on the reason(s)for non compliance : Presence of non-approved substance(s)Presence of approved substance(s) that do not respect the purity criteria of food contactlegislationNo evaluation of migration (by testing or other means of assessment)Presence of substance(s) above the SML / OMLMaterial/item not manufactured according to EU Good Manufacturing Practice (EC) No2023/2006 (or an equivalent GMP)Additional information would need to be given only on the specific substances or circumstancesthat lead to the non-compliance with food contact legislation. If the non-compliance is related toa specific substance, its identity (chemical name, CAS Number) and concentration in thepackaging material / component should be communicated. If the substance is present at in thematerial/component a very low level at which it can be considered as posing no appreciable riskto the safety, it may not be necessary to provide such information. Please see Annex 3(“Threshold for Toxicological Concern, TTC) for guidance on relevant cut-off levels. If a TTCapproach cannot be taken, substances should be communicated if they are present above 1 ppm.The following additional information can give further guidance to the cosmetic product safetyassessor to decide whether or not the non-compliance has an impact on the safety of thecosmetic formulation contained in the packaging. : Has the substance been evaluated by official bodies in relevant regulations (cosmetic,food additives ) and are there recognised safe levels to be considered? In absence of the above, what is the toxicity profile of the substance? If full toxicity profiles are not available, can other approaches based on read across,QSAR (Quantitative Structural-Activity Relationship) 4 be taken into account sars.htm11
Chapter C - Addressing substances of concern to cosmetic safetyassessorsThe information exchange approach described above addresses most of the needs of thecosmetic product safety assessor. However, there are additional regulatory considerationsarising from the Cosmetics Regulation 1223/2009/EC with regard to the presence/ limits ofspecific substances in the cosmetic formulation.Article 14 prohibits or restricts the presence of certain substances in the cosmetic formulation.These substances are listed in Annex II and III. Similarly, article 15 prohibits the use of substancesclassified as CMR substances under Regulation 1272/2008/EC, unless they receive a specificexemption. CMR substances are systematically listed in the corresponding Annexes of theCosmetics Regulation within 15 months after the entry into force of the chemical classification.If any of these substances were present in the packaging and migrated into the formulation,although usually at trace level, they could potentially impact compliance with the aboverestrictions.It should be noted that it is neither useful nor possible under today’s analytical technology tocertify the absolute absence of any substance. This issue is addressed in Article 17 of thecosmetic regulation which stipulates:The non-intended presence of a small quantity of a prohibited substance, stemming fromimpurities of natural or synthetic ingredients, the manufacturing process, storage,migration from packaging, which is technically unavoidable in good manufacturingpractice, shall be permitted provided that such presence is in conformity with Article 3. (i.e.safety of the product)Thus, in order to allow the responsible person of cosmetic products to cope with therequirements of articles 14, 15 and 17, the supplier should provide information on the identity(chemical name, CAS Number) and concentration of Annex II and III, including CMR-classified,substances present in his packaging material / component.Furthermore, the information generated under the approach described under Chapter A and Bis addressing systemic toxicity concerns and does not allow evaluation of local effects (skinirritation, skin sensitisation) of substances migrating into the cosmetic formulation. Whilst skinirritation can generally be addressed through skin compatibility evaluation of the final cosmeticproduct, migration of skin sensitisers in to the formulation needs to be known to the cosmeticproduct safety assessor to carry out a predictive safety assessment.It should be noted that there are currently about 4,000 substances which may fall into the abovecategories of Annex II and III (including CMR substances) or skin sensitisers (based on the publiclyavailable lists under Regulation 1223/2009 and Regulation 1272/2008). However, many of thosesubstances, such as for instance specific oil refinery streams, medicinal / toxic plants, prescriptiondrugs, ) have no relevance for the manufacturing of packaging materials, be it as raw materialsor as by products. Based on expert judgement and experience, such substances can be excludedto allow suppliers of food contact grade and non-food contact grade materials to work with asmaller list of substances to be considered.12
For food contact grade materials, it is possible to reduce further the number of substances bycross referencing the remaining substances with inventory lists of substances that can potentiallybe used in food packaging materials or are known brea
c) Requirements regarding REACH, the Packaging and Packaging Waste Directive 94/62/EC and other legislation . Regarding a potential impact of the packaging on the safety of the cosmetic product, the main concern lies with the potential migration of substances from the packaging into the cosmetic formulation.
