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Analysis of Cosmetic Products

Analysis of Cosmetic Products

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Analysis of Cosmetic Products

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Aug 11, 2011


Analysis of Cosmetic Products advises the reader from an analytical chemistry perspective on the choice of suitable analytical methods for production monitoring and quality control of cosmetic products. In the format of an easy-to-understand compendium of published literature on the subject, this book will enable people working in the cosmetic industry or in research laboratories to:
* become familiar with the main legislative and analytical literature on this subject and
* learn about and choose suitable analytical procedures for production monitoring and control of cosmetic products, according to their composition.
The first section of Analysis of Cosmetic Products covers various definitions and concepts relating to cosmetic products, current legislation in different countries and specific legislation on ingredients. The central body of the book addresses analytical methods for monitoring and quality control of cosmetic products with the fundamental objective being to enable reader's access to scientific reviews carried out by experts in analytical chemistry. The final section contains a small review of the alternative methods to using animals for cosmetic product evaluation.

* An essential resource for those in the cosmetic industry and research laboratories, allowing you to become familiar with the main analytical literature
* Up-to-date and exhaustive overviews of current knowledge dealing with cosmetic analysis, general concepts and legislation
* Including tables and figures, designed to graphically communicate important information in an easy-to-understand format
Aug 11, 2011

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Analysis of Cosmetic Products - Elsevier Science



General Concepts and Cosmetic Legislation


General Concepts and Cosmetic Legislation

General Concepts. Current Legislation on Cosmetics in Different Countries

L. Gagliardi¹*, S. Dorato²

Department of Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma, Italy

Department of Pharmaceutical Sciences, Facoltà di Farmacia, Università di Genova, Italy


Cosmetics represent a global industry with their main markets to be found in the European Union (EU), the Unites States (US) and Japan with a value of 34.3, 25.7 and 11.9 billion euros, respectively, in 2004, according to data compiled by COLIPA, i.e. the European Cosmetic, Toiletry and Perfumery Association (COLIPA, 2005).

To ensure safety and efficacy, cosmetic products are regulated and controlled worldwide. However, harmonisation of laws dealing with cosmetics is far from being achieved and regulatory frameworks vary greatly between countries making it practically impossible for a global industry to sell the same product on all markets.

In the last decade of the 20th century, the three main markets were regulated by different models: a liberal one in the US based on regulations dating back to the late-1930s; in Japan administrative regulations restricted even the choice of common ingredients; while in the EU a modern approach applying a vertical, risk-based directive. In recent years the latter has become an international model, which is easy to understand and more or less easy to apply.

The different national approaches to regulating cosmetics are connected to divergent cosmetic definitions, labelling requirements and lists of ingredients that are permitted, restricted or banned. Apart from these divergences, at the international level an easier distinction can be made by considering the so-called in-market control and pre-market approval approaches. The key features of the in-market control system are the following:

1. Avoidance of time-consuming and expensive pre-market licensing/registration of products.

2. The company responsible for placing the cosmetic on the market is also responsible for the regulatory compliance, for the safety and efficacy of the product, and must be able to justify this on authority investigation.

3. Notifying the appointed competent authority of data concerning the company.

4. Effective in-market control by competent national authorities monitoring the market to check compliance with regulations. Market surveillance is performed through random control on the market (in retail shops), by routine checks on compliance with regulations or by systematic control of given product categories, in the event of a problem arising, like a consumer complaint.

5. In case of non-compliance there can be penalties of varying strength and if the manufacturer fails to prove the cosmetic is safe for use the product will be withdrawn from the market.

6. It encourages companies to ensure product safety and therefore it offers better health protection benefits.

7. Administrations must be aligned and compatible, not identical.

8. One safety standard for consumers.

9. It increases the competitiveness of the market.

10. It ensures that new products will be available to consumers more quickly.

11. It guarantees equal treatment of all companies.

On the other hand, the key features of pre-market approval are:

1. Registration time delays the launch of cosmetics that change quickly in line with developments in technology and/or fashion.

2. It does not prevent fraud or stop illegal products reaching the market.

3. In any event, in-market surveillance is needed to monitor the system, implying a duplication of enforcement procedures.

4. It restricts the availability of new products on the market.

5. Time-consuming procedures and high-registration costs imply higher cost for companies and consequently more expensive products.


The EU Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, known as the EU Cosmetics Directive, was adopted on 27 July 1976 and published in the Official Journal of the European Communities L 262 on 27 September 1976, and has, to date, undergone seven Council and Parliament amendments (i.e. changes in articles) and more than 30 Commission adaptations to technical progress (i.e. changes in the different Annexes regulating banned or restricted substances, cosmetic colourants, preservatives and UV filters).

The European Commission has overall responsibility for cosmetics legislation within the EU, while a competent authority that enforces the legislation is designated in each of the 25 Member States (Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom).

The EU Cosmetics Directive and its amendments represent an autonomous sectorial legislation, based on the principle of risk assessment, having a clear scope based on a clear definition. The main objective of the EU Cosmetics Directive is to ensure a high level of consumer protection, requiring, among other provisions, a safety assessment of each cosmetic by a qualified professional as part of product development. Free circulation of cosmetic products throughout the EU single market is another key point addressed by the EU Cosmetics Directive: a complying cosmetic product can be sold anywhere in the EU without any other national barrier to intra-EU trade, as Article 7.1 states: Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements (…).

In recent years the EU Cosmetics Directive has become the model of modern cosmetic regulations worldwide, representing a dynamic legislation that allows for continuous adaptation to technical progress, leading to relevant restrictions and/or warnings and to rapid inclusion of new regulated molecules (e.g. preservatives, colours, UV filters).

Article 1 of the EU Cosmetics Directive defines a cosmetic product as, (…) any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

Annex 1 of the EU Cosmetics Directive contains a non-exhaustive, illustrative list of the products to be considered as cosmetics within the meaning of the definition in Article 1, which are shown below

• creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.);

• face masks (with the exception of chemical peeling products);

• tinted bases (liquids, pastes, powders);

• make-up powders, after-bath powders, hygienic powders, etc.;

• toilet soaps, deodorant soaps, etc.;

• perfumes, toilet waters and eau de Cologne;

• bath and shower preparations (salts, foams, oils, gels, etc.);

• depilatories;

• deodorants and anti-perspirants;

• hair care products (hair tints and bleaches, products for waving, straightening and fixing, setting products, cleansing products (lotions, powders, shampoos), conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines));

• shaving products (creams, foams, lotions, etc.);

• products for making-up and removing make-up from the face and the eyes;

• products intended for application to the lips;

• products for care of the teeth and the mouth;

• products for nail care and make-up;

• products for external intimate hygiene;

• sunbathing products;

• products for tanning without sun;

• skin-whitening products; and

• anti-wrinkle products.

The definition of a cosmetic identifies the site of application (epidermis, hair system, nails, lips, external genital organs, teeth, oral mucous membranes) and the intended functions (cleaning, perfuming, changing the appearance, correcting body odours, protecting, keeping in good condition). By using the sentence exclusively or mainly the EU Cosmetics Directive foresees that cosmetics may have some functions other than those specified in Article 1, as long as one of the six above-mentioned functions is predominant.

Conversely to the US and Japan, within the EU regulatory frameworks products are mutually exclusive; therefore, there are no intermediate product categories among cosmetics and pharmaceutical or foodstuffs or medical devices (RPA, 2004). The European Court of Justice (ECJ) repeatedly states, in several case laws, that a product can only be either a cosmetic or another type of product but it cannot be both at the same time (the so-called non-cumulation rule) (ECJ, 1991a, 1991b, 2005).

Safety of cosmetics and consumer protection are primarily addressed in Article 2 of the EU Cosmetics Directive, A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account in particular, of the product’s presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market. The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.

The manufacturer, the first importer into the EU or the responsible person for placing a product on the market has the primary responsibility to ensure compliance with the requirements of the EU Cosmetics Directive and, of course, the safety of cosmetics. The EU Cosmetics Directive does not require information on the safety of cosmetics to be submitted to Member State competent authorities before a product is placed on the market, however The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic product before the latter are placed on the Community market (Article 7a.4).

Meanwhile, the Member States designate the competent authorities that will cooperate in areas where such cooperation is necessary to ensure proper application of this Directive.

Each Member State appoints national inspectors, responsible for the in-market surveillance system, who may monitor compliance, visit local manufacturing sites and any retail outlet to see what is sold, take products from the marketplace to official laboratories for compliance testing, act against those companies that do not comply and that may present a threat to consumers and the market (e.g. counterfeit cosmetics), have access to Product Information via direct consultation or through another Member State authority under the principle of mutual recognition. The cooperation system among competent national authorities focuses on mutual recognition, enforcement in the event of non-compliant products and administrative understanding of different national systems.

According to Articles 3, 4 and 5, Member States will have to take all necessary measures to ensure that only cosmetic products that conform to the provisions of the Cosmetics Directive are put on the market. Member States will therefore prohibit the marketing of cosmetics containing,

• banned substances listed in Annex II;

• substances listed in Annex III, beyond the limits and outside the conditions laid down;

• colouring agents other than those listed in Annex IV with the exception of cosmetic products containing colouring agents intended solely to colour hair;

• colouring agents listed in Annex IV, used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair;

• preservatives other than those listed in Annex VI;

• preservatives listed in Annex VI, beyond the limits and outside the conditions laid down, unless other concentrations are used for specific purposes apparent from the presentation of the product;

• UV filters other than those listed in Annex VII; and

• UV filters listed in Annex VII, beyond the limits and outside the conditions laid down therein.

Article 4a, which was inserted in Directive 2003/15/EC (7th amendment to the EU Cosmetics Directive), stipulates that Member States, according to the timetable established by the law, will prohibit the marketing of (…) cosmetic products where the final formulation, in order to meet the requirements of this Directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD, and also, (…) cosmetic products containing ingredients or combinations of ingredients (…) subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD, where OECD is the Organisation for Economic Co-operation and Development. A marketing ban on cosmetics tested on animals and/or containing ingredients tested on animals will take into effect 6 years after the entry into force of this directive, i.e. on 11 March 2009, and a deadline of 10 years after the entry into force of this directive, i.e. on 11 March 2013, for toxicological tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration.

Concerning the labelling of cosmetics (Article 6), Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the container and packaging bear the following information (…):

(a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product inside the EU. Member States may require the country of origin to be specified for goods manufactured outside the Community;

(b) the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than 5 g or 5 ml, free samples and single application packs; for pre-packages normally sold as a number of items for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is only normally sold individually;

(c) the date of minimum durability needs to be indicated by the words best used before the end of followed by either the date itself (month and year or day, month and year) or details of where it appears on the packaging. If necessary, this information should be supplemented by an indication of the conditions, which must be satisfied to guarantee the stated durability. Indication of the date of durability should not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there needs to be an indication of the period of time after opening (Period after Opening—PaO) for which the product can be used without any harm to the consumer. This information is indicated by the symbol shown below, which appears in the EU Cosmetics Directive Annex VIIIa followed by the period (in months and/or years);

(d) particular precautions to be observed in use, especially those listed in the column Conditions of use and warnings which must be printed on the label in Annexes III, IV, VI and VII, which must appear on the container and packaging, as well as any special precautionary information on cosmetic products for professional use, in particular in hairdressing. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol shown below, given in Annex VIII, which must appear on the container and the packaging;

(e) the batch number of manufacture;

(f) the function of the product, unless it is clear from its presentation; and

(g) a list of ingredients preceded by the word ingredients (A more detailed explanation about ingredients labelling is shown in Section 1.2).

According to Article 7, Member States may (…) require that the particulars provided for in Article 6 (1) (b), (c), (d) and (f) be expressed at least in their own national or official language or languages (…).

Article 7a indicates further obligations by manufacturers and importers towards safety and efficacy: The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a), which should be available in the national language of the Member State concerned, or in a language readily understood by the competent authorities,

(a) The qualitative and quantitative composition of the product.

(b) The physicochemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product.

(c) The manufacturing method must comply with the good manufacturing practices (GMP) laid down by Community law or, failing that, laid down by the law of the Member State concerned. To date no definition of GMP has been provided in the regulations, even though the Commission is currently preparing EU guidelines. Voluntary GMP guidelines have been published by COLIPA (2003). The person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State, which is the place of manufacture or first importation.

(d) Assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Guidelines for safety testing have been prepared by the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) (as was formerly named the present Scientific Committee on Consumer Products (SCCP) operating inside the EU Commission), and COLIPA has also published guidelines on safety assessment (SCCNFP, 1999; COLIPA, 1997).

(e) The name and address of the qualified person or persons responsible for the assessment referred to in (d). That person must hold a diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline.

(f) Existing data on undesirable effects on human health resulting from use of the cosmetic product.

(g) Proof of the effect claimed for the cosmetic product, were justified by the nature of the effect or product.

(h) Data on any animal testing performed by the manufacturers, their agents or suppliers, related to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of non-member countries. Without prejudicing protection, in particular, of commercial secrecy and intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Council Directive 67/548/EEC (1967).

Moreover, according to Article 12, If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. (…). The other Member States and the Commission must be immediately informed about this decision and the Commission, if assuming that technical adaptations to the Directive are necessary, should adopt them in accordance with the procedure laid down in the Cosmetics Directive.


Cosmetics in the US are defined according to the Food, Drugs & Cosmetics Act (FD&C Act) dating back to 1938 and, in practice unchanged, excluding the amendments to colour additives. Cosmetics manufactured or imported in the US must comply with the provisions of the FD&C Act, the Fair Packaging and Labelling Act (FPLA) dated 1967 and the regulations published under the authority of these laws. The complete regulations published by the Food and Drug Administration (FDA) can be found in Title 21 of the Code of Federal Regulations (21 CFR).

The FD&C Act defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body (…) for cleansing, beautifying, promoting attractiveness, or altering the appearance. Included in this definition are skin care products, fragrance preparations, manicuring products, lipsticks, eye and facial make-up preparations, bath preparations, hair preparations (non-colouring), hair colouring preparations, oral hygiene products, baby products, personal cleanliness, shaving products, tanning products and deodorants. Soaps consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.

The same FD&C Act defines drugs as (…) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and articles (other than food) intended to affect the structure or any function of the body of man or other animals (…). Over-the-counter (OTC) drugs are those that can be purchased without a doctor’s prescription.

In the US, some products considered as cosmetics in the EU are classified as OTC drugs. FDA reviews these products to establish single monographs under which the drugs are generally recognised as safe and effective, and not misbranded. This reviewing process involves three steps: issuance of a panel report (or advance notice of proposed rulemaking (ANPR)); followed by a tentative final monograph (TFM), which has the legal status of a proposed rule; and finally the establishment of the final monograph (FM). After considering the comments on the panel report, the FDA publishes in the Federal Register ( the tentative final monograph, and finally, when an OTC drug monograph is made final, it is published as a final rule or new regulations in 21 CFR. A product covered by a final monograph must conform to the terms of the monograph. In this sense, specific regulations of different OTC drugs were published, e.g. anti-caries (21 CFR Part 355) and anti-plaque (21 CFR Part 356) toothpastes (fluoride-containing), anti-perspirants (21 CFR Part 350), anti-dandruff and anti-seborrheic products (21 CFR Part 358), skin bleaching products (21 CFR Part 310), sunscreens (21 CFR Part 352) and skin protectant products (21 CFR Part 347 and 358). The OTC monograph process in an ongoing one, also for final monographs, therefore manufacturers should periodically consult either the Federal Register or The Rulemaking History for Drug Products: Drug Category List at FDA’s webpage (see references).

Many products may qualify both as cosmetics and as OTC drugs when they have two intended uses. For instance, a shampoo is a cosmetic, since its intended use is to cleanse the hair. An anti-dandruff treatment is a drug, since its intended use is to treat dandruff. Consequently, an anti-dandruff shampoo is both a cosmetic and a drug. Fluoride-containing toothpastes, deodorants that are also anti-perspirants, moisturizers and make-up products with sunscreen claims are other examples of cosmetic/drug combinations (FDA, 2002).

In many cases, assigning a product to the category of cosmetic or drug depends on the concept of intended use. Claims stated on the product label, in advertising, on the Internet or in any promotional material, consumer perception and some ingredients may cause a product to qualify as a drug, even if marketed as if it were a cosmetic. Claims regarding treatment or prevention of disease or implying it otherwise affects the structure or functions of the human body, makes a cosmetic into a drug.

The FDA regulates the safety of cosmetics, establishes labelling requirements and is also responsible for enforcing laws about cosmetics and the specific department is the Office of Colours and Cosmetics within the Centre for Food Safety and Applied Nutrition (CFSAN). Issues related to drugs are handled by the Center for Drug Evaluation and Research (CDER).

Such laws are enforced by the FDA by means of checking and investigating products, inspecting establishments where products are manufactured or held, determining whether and what toxicological and/or other testing the firm has conducted to substantiate product safety, and seizure of adulterated or misbranded cosmetics.

FDA does not require pre-market approval of cosmetics, neither does it ask firms to register manufacturing premises nor make available safety data or other information before marketing. Manufacturers or distributors of cosmetics may submit information about establishment and cosmetic product ingredients to the agency voluntarily under the Voluntary Cosmetic Registration Program. However, cosmetic firms are responsible for marketing safe, properly labelled products; without using banned ingredients and adhering to limits on restricted ingredients (see further on). If the safety of an ingredient or cosmetic is not adequately substantiated prior to marketing, the label must bear the following conspicuous statement on the principal display panel: Warning–The safety of this product has not been determined.

Other than government agencies, safety of cosmetic ingredients is evaluated and reviewed by the Cosmetic Ingredient Review (CIR), an independent panel of scientific experts setup by the Cosmetic, Toiletry and Fragrance Association (CTFA), looking at all available data and assessing the safety of ingredients used in cosmetics.

The regulatory requirements for OTC drugs are more extensive as, for example, the FD&C Act requires that drug manufacturers register with the FDA at the beginning of the activity, then every year and update their lists of all manufactured drugs twice annually. Additionally, OTC drugs must be manufactured in accordance with current GMP regulations.

Cosmetic manufacturers may use essentially any raw material as a cosmetic ingredient insofar as it is not considered as only a drug active ingredient, and market the product without approval. The law regulates only colour additives specifically approved for cosmetics and a few prohibited and restricted ingredients (e.g. bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides). Cosmetics should not be contaminated with nitrosamines, 1,4-dioxane and pesticide residues, whose potential presence is regularly checked by the FDA (see Section 2.1).

On the other hand, OTC drugs active ingredients are strictly regulated: only the substances present in the positive list of each monograph can be used, and they must conform to the maximum and minimum permitted concentrations. It is extremely difficult to add a new active ingredient to these positive lists, because it must first be used in a therapeutic formula authorised by the cumbersome procedure called New Drug Application.

Cosmetics marketed in the US must comply with the labelling regulations under the FD&C Act and the FPLA. The principal display panel, i.e. the part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of display for retail sale, shall bear a statement identifying the product and an accurate statement of the net quantity, using US measures and additionally the metric system. The latter declaration must be distinct, placed at the bottom of the panel in line, generally parallel to the base on which the package rests.

Other information required on the label are: the name and place of business of the manufacturer, packer or distributor (if the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase Manufactured for (…) or Distributed by (…) or similar wording); the country of origin; appropriate warnings and directions for use (warnings for coal-tar hair dyeing products, aerosols, feminine deodorant sprays, foam baths and products whose safety has not been proven, are compulsory); a declaration of the name of each ingredient in descending order of predominance. Cosmetics, which are also drugs, must first identify the drug ingredient(s) as active ingredients(s) before listing the cosmetic ingredients (see Section 1.2 for a detailed explanation about ingredients labelling). They must also mention a use-by date if their validity is less than three years, and warnings or instructions for use as required by each specific monograph. It is worth noting that the OTC product labelling was standardized to make it easy to read for consumers. The so-called drug facts box has been applied since May 2002 except for OTC products, which are not yet regulated by a final

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