cosmetics Tag

09 May

Posted at 10:28h in Medical

Cos’è il MoCRA?

MoCRA è l’acronimo di Modernization of Cosmetic Regulation Act. Questo atto era contenuto all’interno del Food and Drug Ominibus Reform Act, firmato a fine dicembre 2022 dal Presidente degli Stat Uniti d’America.

Per quanto riguarda i prodotti cosmetici, è la prima modifica sostanziale del regolamento americano a partire dal 1938. Questa modifica viene definita sostanziale poiché introduce degli obblighi per i produttori e rafforza il potere d’intervento della FDA

 

La legislazione prima del MoCRA

Attualmente i prodotti cosmetici all’interno del mercato degli Stati Uniti d’America sono regolamentati dal capitolo VI del Federal Food, Drug, and Cosmetic Act e l’organismo regolatorio responsabile è la Food and Drug Administration (FDA).

Il regolamento corrente non prevede la registrazione di prodotti cosmetici, se non su base volontaria tramite il Voluntary Cosmetic Registratiton Program (VCRP) e non garantisce alla FDA l’autorità di ritirare prodotti non sicuri dal mercato. Tuttavia la FDA può chiedere ad un’azienda di ritirare volontariamente dal mercato un prodotto che sia risultato non sicuro.

Sempre su base volontaria è la produzione seconde le GMP cosmetiche, la cui adozione è raccomandata dalla FDA ma non obbligata, e la segnalazione di effetti avversi da parte dei produttori.

Infine non è obbligatorio fornire in etichetta informazioni dettagliate sugli ingredienti utilizzati come fragranze e non è obbligatorio svolgere test di sicurezza per il prodotto cosmetico.

 

Le novità introdotto dal MoCRA

A partire dal 29 dicembre 2023 entrerà in vigore il MoCRA e verranno introdotte le seguenti novità per quanto riguarda i prodotti cosmetici che verranno resi disponibili sul mercato statunitense:

  • La FDA avrà il potere di ritirare dal mercato prodotti cosmetici non considerati sicuri;
  • I produttori dovranno registrare gli stabilimenti di produzione e i prodotti cosmetici e dovranno inoltre segnalare ogni evento avverso riscontrato alla FDA;
  • In etichetta dovrà essere fornito un recapito che permetta ai consumatori di segnalare eventuali effetti avversi;
  • I produttori dovranno condurre test di sicurezza sui prodotti finiti e fornire queste informazioni alla FDA qualora vengano richieste
  • I produttori avranno l’obbligo di lavorare nel rispetto delle GMP

Invece, a partire dal 29 dicembre 2024, sarà obbligatorio per i produttori indicare in etichetta gli allergeni presenti all’interno delle fragranze utilizzate.

La responsabilità riguardante la registrazione del prodotto, la conservazione dei dati sugli eventi avversi, la fondatezza delle informazioni di sicurezza, l’etichettatura, la presenza di allergeni in etichetta e l’accesso alle informazioni di sicurezza delle fragranze ricadrà tutta sulla Persona Responsabile.

Altre scadenze e aggiornamenti

Anche la FDA avrà delle scadenze da rispettare:

  • Entro il 29giugno 2024 dovrà essere presentato un nuovo regolamento su test standardizzati per rilevare la presenza di amianto in prodotti contenenti talco;
  • Entro il 29dicembre 2025 dovrà essere promulgato un nuovo regolamento riguardante le GMP;
  • Entro il 29 dicembre 2025 dovrà essere effettuata una valutazione delle evidenze scientifiche e dei rischi riguardanti l’uso di PFAS all’interno dei prodotti cosmetici.

 

In conclusione…

Come già detto precedentemente, il MoCRA è una modifica rilevante al regolamento cosmetico statunitense che fornirà maggiori poteri alla FDA e implicherà maggiori responsabilità per i produttori di cosmetici, cambiando nettamente l’approccio delle aziende al mercato USA.

 

Maggiori informazioni possono essere trovate sul sito della FDA (https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022) oppure potete scriverci a chemsafe@chemsafe-consulting.com.

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04 Apr

Posted at 10:19h in Regulatory Updates

ECHA:

ECHA’s Committee for Risk Assessment (RAC) supports the proposed restriction on per- and polyfluoroalkyl substances (PFAS) in firefighting foams. The draft opinion of the Committee for Socio-Economic Analysis (SEAC) is open for consultation until 15 May.

RAC has adopted its opinion on the proposal to restrict the marketing authorisation, use and formulation of all PFAS in firefighting foams, after sector-specific transition periods.

With 470 tonnes of PFAS released into the environment every year, the committee came to a close that there is an EU-wide risk for people and the environment from their use in firefighting foams. The proposed restriction would effectively decrease emissions and the associated risks caused by these persistent substances. The committee’s concerns are based on the ‘very persistent’ property combined with others, such as ‘mobility’.

 

Cosmetics:

ECHA’s Enforcement Forum agreed to run a pilot project to check for the presence of restricted perfluorocarboxylic acids (PFCAs) and related substances in consumer products such as cosmetics.

Inspections in this pilot project starts in 2023 and continue throughout 12 participating countries during 2024. The goal is to protect consumers from being exposed to PFCAs and related substances, as well as perfluorooctanoic acid (PFOA), which have been highlighted as substances of very high concern due to their hazardous properties.

The project will also bring awareness about the restrictions under the REACH and Persistent Organic Pollutants (POPs) regulations among companies that sell cosmetics and other consumer products. It was triggered by cases of PFOA, the use of which is restricted under the POPs Regulation, found in cosmetics sold on the EU market.

Inspectors can enforce restrictions under the REACH or POPs Regulation, as applicable. Where breaches are detected, inspectors will take enforcement measures to guarantee compliance with the applicable legislation. The project report should be published at the end of 2024.

PFOA and related substances are outlawed in the EU market under the POPs Regulation. Cosmetics are not excluded from this prohibition. REACH also restricts the use of PFCAs as substances on their own as well as in mixtures and articles. Furthermore, REACH specifically outlaws the use of certain substances that are toxic to aquatic life in wash off cosmetics.

 

CLP:

On March 31, It was published in the Official Journal on “Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards the criteria and hazard classes for the classification, labelling and packaging of substances and mixtures”.

The Regulation, which amends Annexes I, II, III and VI of the CLP, introduces the following new hazard classes, with relevant H and P phrases and classification criteria for substances and mixtures:

– Endocrine interference for human health

– Interference with the endocrine system for the environment

– Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties

– Persistent, mobile and toxic or very persistent and very mobile properties

For all hazard classes, the Regulation provides the following dates of application:

– Substances: are classified by 1 May 2025 at the latest; however, substances placed on the market before 1 May 2025 shall not be classified until 1 November 2026.

– Mixtures: they are classified by 1 May 2026 at the latest; however, mixtures placed on the market before 1 May 2026 are not subject to classification until 1 May 2028.

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28 Mar

Posted at 10:03h in Medical

Dal 1° gennaio 2021 è ufficialmente entrato in vigore il nuovo regolamento cosmetico cinese, il Cosmetic Supervision and Administration Regulation (CSAR), che stabilisce i nuovi requisiti per la vendita di prodotti e ingredienti cosmetici all’interno del mercato cinese, fra quelli con il volume d’affari e la crescita maggiore nel settore beauty.

Il focus principale del nuovo regolamento è la garanzia di una maggiore sicurezza del prodotto finito tramite una serie di step di registrazione e controllo pre-market.

L’autorità competente per il mercato cinese è la National Medical Product Administration (NMPA)

 

Definizioni

Con l’entrata in vigore del CSAR è stata introdotta anche una nuova definizione di prodotto cosmetico, ovvero: un prodotto chimico industriale di utilizzo quotidiano applicato su pelle, capelli, unghie, labbra e altre superfici corporee per strofinamento, mediante spray e altri metodi simili con lo scopo di pulire, proteggere, abbellire e modificare.

I prodotti cosmetici finiti vengono a loro volta divisi in prodotti “speciali” (coloranti e permanenti per capelli, prodotti per la rimozione delle lentiggini, prodotti anti-caduta, protezioni solari e qualsiasi prodotto con nuove proprietà) e prodotti cosmetici ordinari.

 

Registrazione

Il CSAR richiede di registrare i prodotti cosmetici prima dell’immissione in commercio, fornendo anche le informazioni tossicologiche di sicurezza. L’iter di registrazione varia a seconda della tipologia di prodotto: per i prodotti ordinari la revisione tecnica del report potrà essere effettuata a campione dopo la messa in commercio, mentre per i prodotti speciali verrà effettuato un controllo da parte dell’NMPA prima della messa in commercio, dilatando ovviamente i tempi di autorizzazione.

 

Ingredienti

Anche per quanto riguarda gli ingredienti cosmetici bisogna presentare un report sulla sicurezza.

Quando si vuole utilizzare un ingrediente cosmetico per la produzione di cosmetici destinati al mercato cinese, per prima cosa bisogna verificare se l’ingrediente è presente sull’Inventory of Existing Cosmetic Ingredients in China (IECIC), una lista degli ingredienti cosmetici già autorizzati dall’autorità competente cinese. Se l’ingrediente è presente nella lista, sarà sufficiente fornire le informazioni di sicurezza. Nel caso l’ingrediente non sia presente e quindi classificato come “nuovo”, verrà richiesto al responsabile per la sicurezza dell’ingrediente di registrarlo sulla piattaforma dell’NMPA. L’ingrediente verrà successivamente sottoposto ad una sorveglianza post-market della durata di 3 anni. Nel caso non dovessero sorgere problematiche inerenti alla sicurezza, l’ingrediente verrà aggiunto all’IECIC.

Sia che si effettui la registrazione di un ingrediente già esistente o di un ingrediente “nuovo”, la piattaforma fornirà un codice univoco. Questo codice potrà servire successivamente al produttore del prodotto finito durante la registrazione di quest’ultimo qualora il fornitore dell’ingrediente non voglia fornire le informazioni di sicurezza  e si occupi direttamente lui della registrazione dell’ingrediente cosmetico. In questo modo potrà mantenere la riservatezza delle informazioni poiché queste saranno visualizzabili solo dall’NMPA

 

Come fare per essere in compliance

A livello pratico la piattaforma per la registrazione dell’NMPA è disponibile esclusivamente in cinese e nella stessa lingua devono essere fornite le informazioni di sicurezza. Inoltre le società non cinesi devono fornire la licenza commerciale tradotta e farla autenticare dall’ambasciata cinese locale. Infine è richiesta anche una persona responsabile stabilita in Cina, che può anche essere nominata tramite delega.

Tutti questi requisiti possono essere un ostacolo per le società europee; perciò, è fondamentale affidarsi al supporto di esperti. Chemsafe, tramite i suoi partner internazionali, può fornire supporto e consulenza per adempire a ognuno di questi requisiti.

 

Se volete saperne di più non esitate a contattarci a chemsafe@chemsafe-consulting.com.

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29 Nov

Posted at 10:32h in Medical

What is a claim:

Claim is a slogan or description of the product that allows you to present the product itself to the customer, focusing attention on the main features, allowing him to choose the most suitable cosmetic product for his needs and for the company to stand out in the market.

 

Reference regulation:

For this reason, to avoid untrue or misleading words that prevent the customer from making an informed choice and that provide an improper advantage to the company, even the claims that can be applied on the labels of cosmetic products are governed by a specific regulation.

The reference regulation is Reg. (EC) 655/2013 ” laying down common criteria for the justification of claims used in relation to cosmetic products” and in particular its only annex, which groups together the common criteria that must comply with the claims of cosmetics product.

 

Common criteria for claims:

The common criteria are divided into six points:

  1. Legal compliance

For cosmetic products no registration or authorization by the authorities are needed. For this reason, claims such as “authorized by the European Commission” or “Registered Cosmetic” are not allowed. Similarly, it is not allowed to use claims that may give the impression of a particular benefit, if this benefit is a legal requirement. For example, the claim “Not tested on animals” is not allowed because animal testing for cosmetic products and their ingredients is prohibited by the European regulation, or “Without formaldehyde” since every cosmetic product must be formaldehyde-free as an ingredient prohibited within cosmetic products.

  1. Truthfulness

If the presence of a specific ingredient is declared or a specific property of an ingredient is reported, the finished product must contain that specific ingredient or having that property itself. For example, it is not possible to report “With lemon juice” if only lemon flavor is present or “With moisturizing plant extracts” if the finished product does not have moisturizing properties. Then, commercial messages must not give the impression that the opinions expressed are verified statements, unless they are supported by verifiable evidence.

  1. Evidential support

This section establishes some criteria regarding the studies and evidence that must be presented in support of a claim. It is also specified that for claims that are clearly exaggerated or abstracted, there is no need for supporting evidence. For example, the claim “For hair as soft as a cloud” does not need proof because it is an abstracted and exaggerated comparison.

  1. Honesty

The presentation of a product’s performance should not go beyond the available supporting evidence. Furthermore, specific characteristics cannot be attributed to the product if similar products possess them and the specific conditions to which the action of a product is linked must be declared. For example, if the anti-wrinkle effect of a cream is bound to the simultaneous use of a face serum, then it must be specified. Writing “This cream makes your skin younger” is incorrect, as the consumer does not perceive that he also needs the serum to benefit from the declared effects.

  1. Fairness

Product claims must not disparage competing products or create confusion with them. For example, “Without acidic ingredients that can irritate the skin” is disparaging towards competitive products that contain them.

  1. Informed decision-making

Marketing communications shall take into account the capacity of consumers to understand the messages and be easily understandable. Furthermore, the claims are an integral part of the products and shall contain information that allows the average end user to make an informed choice.

 

For more information:

REGULATION (EU) N. 655/2013

https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32013R0655

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05 Oct

Posted at 14:58h in Regulatory Updates

Cosmetics:

EU to set labelling requirement for 56 additional fragrances in cosmetic products.

The European Commission is planning an amendment to the cosmetics Regulation that will set a labelling requirement for an additional 56 fragrance allergens.

The changes, set out in a European Commission draft amendment, mean cosmetic products in the EU must list on their labels 81 allergenic chemicals found in fragrances or essential oils if they are present at levels greater than 0.001% for leave-on products or 0.01% for rinse-off products.

The new substances, derived from synthetic fragrances, include;

  • menthol;
  • terpineol;
  • linalyl acetate;
  • camphor;
  • vanillin; and
  • geraniol derivatives (geranial and geranyl acetate).

The newly added substances also include some natural essential oils/extracts such as ylang ylang oil (cananga odorata flower oil), cinnamon oil (cinnamomum zeylanicum bark oil) and lavender oil (lavandula officinalis flower oil).

The amendment offers companies a transition period of three years from when the amendment takes effect to reformulate their products and comply. However, it also gives five years for the withdrawal of non-compliant products.

Currently, 25 cosmetic fragrance ingredients, listed in Annex III of the cosmetics Regulation, must be included in the list of product ingredients on cosmetics packaging, while all other fragrances can be listed as “parfum” or “aroma”.

The draft amendment follows a 2012 Opinion by the Scientific Committee on Consumer Safety (SCCS) that identified the additional 56 allergens, which have caused allergies in humans and have currently no requirement of individual labelling.

The Commission is expected to open the amendment for feedback soon, after which it is expected to be adopted in the first half of 2023, according to a WTO notification.

 

ECHA

Commission bans 14 CMRs under EU cosmetic products Regulation.

New concentration limits for uses of methyl salicylate

The European Commission has banned 14 carcinogenic, mutagenic or toxic for reproduction (CMR) chemicals from being used in cosmetic products.

A Commission amending Regulation, dated 15 September, has added the chemicals to the prohibited substances list under Annex II of the cosmetic products Regulation.

The banned CMRs include:

  • tetrafluoroethylene;
  • 3-methylpyrazole;
  • 4-methylpentan-2-one oxime;
  • 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol; and
  • methyl isobutyl ketone.

The ban will come into force on 17 December and cover all cosmetic products on the EU market, imported and EU-made. It marks the fifth annual update to the Commission Regulation restricting and/or prohibiting the use of CMR substances in cosmetic products.

Methyl salicylate

The amending Regulation also introduces new restrictions on the use of methyl salicylate, an ingredient in many fragrance mixtures and oral hygiene products.

The European Commission’s Scientific Committee on Consumer Safety (SCCS) concluded in October that the substance is safe when used in cosmetic products up to set maximum concentrations.

However, the SCCS pointed out that methyl salicylate is also used in other consumer products, such as household cleaning items, so combined exposure could exceed safe levels.

Therefore, the use of methyl salicylate will be restricted as follows:

  • up to 0.06% in leave-on skin products (except face make-up, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
  • up to 0.05% in face make-up (except lip products, eye make-up and make-up remover);
  • up to 0.002% in eye make-up and make-up remover;
  • up to 0.009% in leave-on hair products spray/aerosol;
  • up to 0.003% in deodorant spray/aerosol;
  • up to 0.4% in body lotion spray/aerosol;
  • up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
  • up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
  • up to 0.03% in lip products;
  • up to 2.52% in toothpaste;
  • up to 0.1% in mouthwash intended for children aged 6-10 years; and
  • up to 0.65% in mouth spray.

Methyl salicyclate is banned from use in cosmetic products for children under six. The only exception is toothpaste.

 

REACH

European Commission adopts authorisation decision for use of 4-tert-OPnEO

EU executive permits application of the endocrine disruptor in pharmaceuticals

The European Commission has adopted a REACH authorisation decision granting a specific use of the SVHC 4-tert-OPnEO.

In an EU Official Journal entry on 13 September, the EU executive announced it has permitted Pfizer Manufacturing Belgium use of the chemical – also known as 4-(1,1,3,3-tetra methylbutyl)phenol, ethoxylated – as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.

The review period runs until 4 January 2030. The Commission said it granted permission for this use because it believes the socio-economic benefits outweigh the risk to human health and the environment from the uses of the substance, and that suitable alternative substances or technologies do not exist.

The substance is listed on the REACH Annex XIV authorisation list for its endocrine disrupting properties affecting the environment. The latest application date for 4-tert-OPnEO was 4 July 2019, and it had a sunset date of 4 January 2021.

In March, in its parallel UK REACH legislation, the Department for Environment, Food and Rural Affairs (Defra) approved an application for a use of the substance.

At the EU level, the Commission has been working on plans to reform the authorisation process under REACH as part of its wide-ranging chemicals strategy for sustainability.

Pharma

QSAR Toolbox extension broadens possibilities for animal-free chemicals assessment

The new add-on helps users to predict chemical properties, including endocrine activity, while avoiding testing on animals.

The OPERA extension contains models for predicting properties that are important for assessing chemical hazards. The extension can be used to screen chemical databases to identify substances that may cause endocrine disruption. It also helps users to estimate acute oral toxicity and other regulatory relevant properties.

Developed by the US National Institute of Environmental Health Sciences (NIEHS), OPERA can predict properties related to the absorption, distribution and metabolism of substances that can strengthen read-across justifications and facilitate the regulatory use of in vitro test results.

The extension can be downloaded for free from the QSAR Toolbox Repository.

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28 Jun

Posted at 08:37h in Chemical

ECHA’s Biocidal Products Committee (BPC) met on 8-9 and 14-16 June 2022 and discussed a great number of opinions. These concern five opinions on active substances, ten on requests from the European Commission and nine opinions on Union authorisation.

The committee stands behind the approval of the active substance formic acid for product-types 2, 3, 4, 5 and for use in preservatives for products throughout storage (product-type 6). The opinions will be available on the BPC’s web page in the near future.

The opinions regarding the requests from the European Commission include those on availability and suitability of alternatives to hexaflumuron and on endocrine disrupting properties of formaldehyde releasers.

Finally, the committee supported the following positive opinions on Union authorisations:

  • active chlorine released from chlorineused in disinfectants and algaecides not meant for direct use on people or animals (product-type 2) and for disinfection of drinking water for humans and animals (product-type 5);
  • calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limefor product type 2, and for use in disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function (product-type 3);
  • calcium oxide/lime/burnt lime/quicklimefor product-types 2 and 3;
  • peracetic acidfor product-types 2, 3 and for use in disinfecting equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals (product-type 4);
  • hydrogen peroxidefor product-types 2 and 4;
  • L-(+)-lactic acidfor product-types 3 and 4;
  • L-(+)-lactic acidfor product-types 2, 3 and 4; and
  • 3-iodo-2-propynylbutylcarbamate (IPBC) used in preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects (product-type 8).

The committee does not stand behind a Union authorisation for hydrogen peroxide for toilet bowl disinfection in professional environments, such as hospitals (product-type 2). The BPC decided that, among other things, the measures that had to be taken to prevent or mitigate exposure throughout use would not be practical nor feasible. It was also said that some co-formulants of the product lead to unacceptable environmental risks.

One Union authorisation opinion concerning chlorocresol was postponed and will be adopted via written procedure.

The European Commission together with EU Member States will make the final decision on approval of active substances and on Union authorisation of biocidal products.

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21 Jun

Posted at 08:30h in Medical

Cosmetic packaging

Packaging material means the container (or primary packaging) that is in direct contact with the formulation.

Within the Regulation (EC) 1223/2009, article 10 says: ” In order to demonstrate that a cosmetic product complies with Article 3, 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 relevant information and that a cosmetic product safety report is set up in accordance with Annex I. ”

In Annex I, section 4, requires reporting “Impurities, traces, information on packaging material” within the safety assessment.

Requests for information on packaging is more detailed in the Commission Implementing Decision 2013/674/EU, where it is indicated that the relevant characteristics of the packaging material in direct contact with the final product are important for the safety of the product and that the reference to Regulation (EC) 1935/2004 may be useful.

Therefore, packaging of cosmetic product must be safe for consumer like the product itself.

 

Effects of packaging on product safety

The combination of packaging material, cosmetic product formulation and contact with the environment

external effects could affect the safety of the finished product, due to the following factors:

a) interaction between the product and the packaging material;

b) barrier properties of the packaging material;

c) migration of the substance from / to the packaging material.

Therefore, when evaluating the packaging, the evaluator must take into account the possible interactions between the components of the packaging and the finished product, the effectiveness of the packaging to isolate the product from the external environment (this also affects the duration of the product after opening) and the substances that can migrate from the packaging to the product and therefore come into contact with the final consumer.

 

What information is needed for packaging evaluation

As there is no specific regulation for cosmetic packaging, the European Commission recommends referring to Reg. 1935/2004 regarding materials and objects intended to come into contact with food.

This indication is taken up by Cosmetic Europe within its guidelines, where it suggests the approach to be adopted in the evaluation of packaging whether it follows the food regulation or not.

 

Packaging in compliance with food regulation

in the majority of cases, if the packaging is safe for a specific type of food, it should also be suitable for cosmetics that have similar physical chemical properties as this food.

If compliance has been based on migration into food/food simulants, the cosmetics assessor needs to decide whether the food/simulants and test conditions/assumptions are applicable to the cosmetics formulation.

Obviously, the evaluator will also have to take into account Annexes II and III of the cosmetic regulation (prohibited and restricted substances).

 

Packaging not in compliance with food regulation

A Cosmetic packaging material might not be food contact compliant because of the presence of a substance that is not authorised for food contact materials or used outside of restrictions set for such use. Non-compliance could also be linked to the material not having been manufactured according to GMP Regulation (EC) N°2023/2006. Such packaging may still be perfectly safe for use in a cosmetic application after the performance of the safety assessment. References to other standards like e.g. pharmaceutical standards or food and feed additives might be helpful in generating useful support information.

 

Sources:

 

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03 May

Posted at 10:00h in Medical

One of the most significant changes introduced by the Scientific Committee on Consumer Safety (SCCS) in the Notes of Guidance with the eleventh revision of March 2021 is the use of two mathematical models for the calculation of inhalation exposure.

Cosmetic products, by definition, are designed to be applied to the external surfaces of the human body, teeth and mucous membranes of the mouth. However, sometimes these products, or some of the ingredients that compose them, can be inhaled in the form of vapours, powders and aerosols.

The first model applies to products that can generate vapours (for example liquid products that contain volatile solvents). For these products, the inhalation Systemic Exposure Dose (SEDinh) of the ingredients is calculated by multiplying the daily exposure to the product by the concentration and evaporation fraction (a value between 0 and 1).

The second model applies to powder and spray products. Spray products fall into two categories: propellant sprays (which produce a finer aerosol) and pump sprays (which produce a less fine and more difficult to inhale aerosol).

For the assessment of inhalation exposure to these types of products, the SCCS proposed the use of a 1- or 2-Box model.

In a classical 1-Box model it is assumed that the entire spray amount is instantaneously released into the air and distributed in a box of a specific size, which e.g. simulates the breathing zone. The resulting air concentration is then multiplied by the breathing rate and the time spent in the box to calculate the exposure. A 2-Box model takes into account the dilution of the substance over time. As in the 1-Box model, the assumption is that the spray is instantly released and distributed in a box around the head. There the aerosol is present for exposure over a defined time, after which the full amount of aerosol in the first box is transferred to a larger second box (representing a room where the product is used), where it is available for inhalation for a second defined time period. For a conservative approach, the air exchange (fresh air getting in, exhaust air getting out) can be assumed as zero.

In addition to the size of the two boxes and the time that the product remains in suspension, the size of the aerosol generated by the product must also be taken into account for the calculation of the SEDinh, which vary according to the type of spray used. A finer aerosol is more easily breathable and consequently the substances contained within will be more systemically available.

The application of these mathematical models allows a better characterization of exposure to the ingredients contained within cosmetic products and is a further step towards a greater guarantee of safety for the final consumer.

For more details see:

https://ec.europa.eu/health/system/files/2021-04/sccs_o_250_0.pdf

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