#medical devices Tag

The label is one of the fundamental parts of the cosmetic product. It is the element that allows the consumer to know what is inside the product, what precautions to take for its use and how long the product can be used safely.

The information to be reported on the label is listed in Article 19 of Regulation (EC) 1223/2009.

This information must be reported on the container and packaging of the product in indelible, easily legible and visible characters. The language of the information shall be determined by the law of the Member States in which the product is made available to the end user.

Information required on the label

name or registered name and the address of the responsible person.

If several names (e.g. name of the actual manufacturer of the product and name of the responsible person) or addresses are reported on the label, the one where the responsible person makes readily available the product information file shall be highlighted. Usually, to highlight it, it is reported in bold or underlined name to distinguish it from the others. In the case of an imported product, the country of origin must also be present.

nominal content at the time of packaging.

The content value must be reported by weight or volume (e.g. 5 ml or 5 g).

date of minimum durability.

It is the date until which the cosmetic product, stored in suitable conditions, will continue to perform its initial function and will remain safe for human health.

The date of minimum duration is shown next to the special symbol in point 3 of Annex VII or by the words: “best used before the end of”.

It is not necessary to report the date for products with a minimum duration of more than 30 months, but in those products shall be r

eported the Period After Opening (PAO), i.e. the period of time (expressed in months or years) after opening in which the product is still considered safe for human health. The PAO is shown together with the symbol in point 2 of Annex VII. The PAO is not necessary for disposable products or products that do not come into contact with the external environment.

special precautions for use.

Those indicated in Annexes III and IV, any precautions for professional use and those indicated by the safety assessor within the PIF must necessarily be reported

batch number.

or in any case a reference that allows to identify the product.

function of the cosmetic product

unless it is clear from its presentation.

list of ingredients.

The ingredients must be reported in descending order of weight at the time of incorporation into the finished product. Ingredients with a concentration of less than 1% can be listed in no particular order. The ingredients must be reported according to INCI nomenclature, except for the aromatic and odorant compounds that can be reported with the names “parfum” or “aroma” and the colouring compounds that must be reported with their Color Index number. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol “+/-” are added. Nanomaterials must be accompanied by the word “nano” in brackets.

What to do if a label cannot be applied to the product

If for practical reasons it is not possible label the list of ingredients and the special precautions for use, the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card. The consumer must be referred to these indications applying the symbol in point 1 of Annex VII on the label

In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information about list of ingredients to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.

  CLP and cosmetic label

Regulation (EC) 1272/2008 does not apply to cosmetic products, therefore hazard pictograms must not be applied on the label of cosmetic products. Sprays with propellant are an exception, as the propellant is subject to the aerosol directive (75/324/EEC). Therefore, on this type of products, the pictogram indicating flammability and other symbols may be requested.

 

In conclusion.

As cited above, label is one of the fundamental parts of the cosmetic product, within PIF. The label allows the consumer to use the product in a conscious way and avoid inappropriate and dangerous uses. Like every request of the Regulation 1223/2009, is responsibility of the responsible person to ensure that all information is correctly reported on the label.

 

Form more informations:

Regulation (EC) 1223/2009:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=it

Council Directive (75/324/EEC) :

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31975L0324&from=IT

Ministero della Salute:

https://www.salute.gov.it/portale/temi/p2_6.jsp?area=cosmetici&id=146&menu=presen#:~:text=L’etichetta%20rappresenta%20il%20mezzo,livello%20di%20informazione%20circa%20le

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.

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:

 

Introduction:

In May the MDCG Guideline 2022 – 5 “Guidance on Borderline between medical devices and medicinal products under MDR 2017/745” was published, at the conclusion of a long comparison within the Community.

Borderline products are those products that by their nature are not immediately traceable to a particular sector, for which it is therefore difficult to define what is the reference legislation to be applied.

The demarcation between Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and Directive 2001/83/EC on medicinal products (MPD) for human use on the other is crucial for the implementation of these legislative acts and for their correct interpretation and application.

 

General aspects:

As a general rule, a product is regulated either by the MDR or by the MPD but not both. The conformity assessment procedure or the marketing authorisation procedure to be followed prior to placing a given product on the market will therefore be governed either by the MDR or by the MPD.  The procedures of both regulatory regimes do not apply cumulatively. However, for products that have properties of both medicinal products and medical devices (e.g. medical devices incorporating as an integral part, a substance which, if used separately, would be considered to be a medicinal product), some cross-references are made within one regime to specific provisions of the other regime.

The wording of Article 2(2) of the MPD shows that it only applies if, after a case-by-case assessment, taking in consideration all the characteristics of a product, the product in question may fall within the definition of both, medical device and medicinal product. In such a case, the provisions of the MPD applies5. The MDR and the MPD may not be applied cumulatively.

The aim of this guideline is to support the uniform application of the Regulation throughout the European Union.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

According to Article 1(6)(b) of the MDR, in deciding whether a product falls under the MDR or the MPD particular account shall be taken of the principal mode of action of the product. The nature of the principal mode of action i.e. whether it is pharmacological, immunological or metabolic or other is generally the same irrespective of the quantity.

According to Article 2(1) MDR a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but may be assisted in its function by such means. The concept that a medical device may be assisted in achieving its principal intended action by pharmacological, immunological or metabolic means should be understood as covering those cases when the medical device incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product, and that has an action ancillary to that of the device.

Typically, the medical device’s principal intended action is achieved by physical means (including mechanical action, physical barrier such as a film, lubrication, heat transfer, radiation, ultrasound, replacement of or support to organs or body functions). Furthermore, hydration or dehydration and pH modification may also be means by which a medical device achieves its principal intended action.

The determination of the nature of the substance, i.e. whether it is “considered to be a medicinal product” is independent of the intention of the manufacturer, of the quantity of the substance in the device and of the method or route of administration.

 

Conclusion:

The document may be revised in the light of the update of technical-scientific knowledge and in the light of the results of discussions within the Borderline and Classification medical devices expert group (B&C) of the Medical Device Coordination Group.

 

For more information: https://ec.europa.eu/health/latest-updates/mdcg-2022-5-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2022-04-26_en

Webinar – La valutazione biologica di un dispositivo medico

Martedì 31.05.2022

Ore 10:00 – 11:00

Programma:

  • La valutazione biologica come parte del processo di gestione del rischio
  • Perché eseguire la valutazione della sicurezza biologica
  • Come dimostrare la conformità ai RGSP
  • La caratterizzazione chimica come requisito necessario per una corretta valutazione biologica
  • Il “Biological Evaluation Plan” (BEP)

 

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