#medical Tag

Introduction:

The end of the state of emergency will be the end of the derogation regime which, in view of the exceptional situation resulting from the SARS-cov-2 pandemic, has introduced into our legislation the possibility of placing on the market surgical masks authorised by derogation. From 1 April 2022, manufacturers who want to continue to market surgical masks in Italy will have to comply with the ordinary legislation on medical devices.

For authorised masks already placed on the market, the Circular of 4 March 2022 (https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86093&parte=1%20&serie=null ) indicates that they may be made available only until 31 May 2022 and that only masks that are part of existing stocks available to personnel participating in efforts to contain the virus and prevent its further spread may be made available until such stocks are exhausted and at the latest by 31 July 2022.

The circular of 4 March 2022 clarified certain aspects of the procedures for placing surgical masks on the market in view of the imminent expiry of the state of emergency.

The circular recalls that from 26 May 2021 it is no longer possible to place on the market surgical masks marked CE pursuant to Directive 93/42/EEC, implemented in Italy with the d.lgs. 46/97, and it is stressed that manufacturers who intend to place on the market surgical masks, must ensure compliance with the requirements of Regulation (EU) 2017/745.

 

Technical Documentation:

According to MDR 2017/745 before placing a device on the market, the manufacturer is obliged to prepare the technical documentation that must enable it to assess its compliance with the general performance and safety requirements(GSPR) set out in Annex I to the Regulation.

This documentation shall be presented in a clear, organised, unambiguous and easily searchable format and shall include methods and test results to support compliance with the specifications. For surgical masks, these are mainly tests of bacterial filtration (BFE) efficiency, respirability (Pa/cm2), microbial contamination (cfu/g), splash resistance (kPa) (only in the cases provided, type IIR masks) and biocompatibility.

The manufacturing, design and performance requirements and test methods for surgical masks are set out in UNI EN 14683:2019 “Medical face masks – Requirements and test methods”, which, although not yet harmonised in accordance with the Regulation (cf. Circular of 12 November 2021) is the main tool for the manufacturer to demonstrate the conformity of the device.

 

Quality Management System (QMS):

To ensure that series production continues to comply with the requirements of the Regulation, the manufacturer establishes, documents, applies, maintains, updates and constantly improves a quality management system, in accordance with the obligations laid down in art. 10, paragraph 9 of the Regulation.

 

Post Market Surveillance:

The manufacturer shall establish and update a post-market surveillance system throughout the life cycle of the device.

 

In conclusion, the manufacturers of surgical masks already CE marked, in accordance with Directive 93/42/EEC, and persons who have obtained derogation authorisations for the production and marketing of surgical masks having an interest in continuing to regularly place on the EU market its own masks such as medical devices, must follow all the indications contained in the Circular and in the reference standards indicated.

 

For more information:

https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5834

 

 

 

 

What is IFRA?

The International Fragrance Association (IFRA), founded in 1973, represents the interests and is the voice of the fragrance industry worldwide. It promotes the safety and benefits of the fragrance industry’s products through stakeholder dialogue on a global basis.

When warranted by concerns regarding the safe use of a specific ingredient identified by the Research institute for Fragrance Materials (RIFM) safety assessment program, IFRA will issue an IFRA Standard as part of an IFRA Amendment.

IFRA Standards

To ensure the safety of fragrances, IFRA has established rules (known as IFRA Standards) recognized by government authorities and commercial entities around the world.

IFRA Standards can either prohibit, restrict or set purity requirements for specific ingredients. The safety of ingredients, whether the subject of an IFRA Standard or not, remains the responsibility of IFRA members. Compliance with IFRA Standards is therefore necessary for compliance with the IFRA Code of Practice but may not be sufficient to ensure regulatory compliance and the safety of fragrance mixtures or ingredients.

The IFRA Standards and related documents are subject to regular changes as new information relevant to the safety of fragrance ingredients become available. All these changes are part of an IFRA Amendment, which is designed pursuant to an inclusive procedure and is subject to a broad consultation of all relevant stakeholders before its Notification. Last one is the 50th Amendment, an ‘off-cycle’ amendment for one ingredient, Mintlactone, published on 30 June 2021.

The Expert Panel for Fragrance Safety is an independent panel of experts that reviews the activities of the Research Institute for Fragrance Materials (RIFM). They determine safety of use for fragrance ingredients through consideration of available information and active generation of additional data. If the Expert Panel for Fragrance Safety determine that a restriction of use is necessary for consumer and environmental protection, an IFRA Standard will be published.

All fragranced consumer products are in the scope of the IFRA Standards except for products clearly not covered in the RIFM Safety Assessments, such as:

– medical devices;

– prescriptive drugs;

– aromatherapy applications;

– consumer products used in occupational settings (e.g. shampoos applied in hair salons, hand sanitizers applied in hospitals, etc.).

A detailed list of the products covered under the scope of the IFRA Standards is provided in “Guidance for the Use of IFRA Standards”. In case a final product application is not included therein, it remains the responsibility of the final consumer product manufacturing company to adequately categorize this final product application in order to comply with the requirements of the IFRA Standards.

For practical reasons, IFRA Standards are set per product category, each covering a range of product types which can be grouped together based on risk assessment considerations.

With IFRA 49th Amendment, issued at the beginning of 2020, the number of categories in the IFRA Standard has changed from 11 categories for dermal sensitization Standards and 4 for systemic toxicity-based Standards to 12.

Product categorization is achieved by grouping consumer product types based on functional type, and major factors in habits and practices of consumers such as area of use (head, face, axillae, etc.) and whether they are rinse-off or leave-on applications.

Certificate of conformity

The Certificate of Conformity to the IFRA Standards is a document established by companies creating fragrance mixtures, which declares compliance with the requirements expressed in the IFRA Standards and confirms that a specific fragrance mixture up to a certain concentration can be used in a specified consumer product in compliance with up to and including a specific Amendment (the number and the Notification date of the Amendment should be stated in the Certificate).

The Certificate is only applicable for fragrance mixtures intended to be directly included in a finished consumer product. By using a Certificate, a fragrance supplier assures its customer that the product they supply is in compliance with the requirements set by the IFRA Standards for an intended use.

It is important to note that IFRA is not involved in its preparation and that the Certificate of Conformity declares compliance with the requirements expressed in the IFRA Standards but does not replace a safety assessment.

 

Source: https://ifrafragrance.org

Fraunhofer ITEM leading an EMA-funded research project

 

Nitrosamines (NAs) are a class of organic chemical compounds that humans may be exposed to by tobacco smoking or consuming certain foods. N-nitrosamines have been classified as probable human carcinogens and are categorized in the ICH M7 guideline as belonging to the “cohort of concern” group of high-potency mutagenic carcinogens. Some active pharmaceutical ingredients (APIs) carry NAs as impurities from production and/or storage or may cause their formation in the gastrointestinal tract.

A joint research project funded by the European Medicines Agency (EMA) and led by Fraunhofer ITEM will shed light on the mutagenicity of different classes of NAs to distinguish highly potent from less potent carcinogens. Besides classical nitrosamine structures, API-like nitrosamine derivatives will also be investigated. It will be of particular importance to look for their ability to undergo metabolic activation and to form different DNA adducts. Additionally, corresponding DNA repair mechanisms will be addressed for the first time. By developing novel in-silico as well as in-vitro test systems, the consortium aims to improve risk assessment and to derive reference doses such as acceptable intake (AI) values.

Initially, the focus will be placed on nitrosamine metabolites and their potential to damage DNA when not adequately repaired. The obtained data will be used to correlate the structure of NAs to their potential toxic/mutagenic effects. By means of a quantitative structure-activity relationships (QSAR) approach, this will allow derivation of acceptable intake values for compounds lacking appropriate in-vivo cancer studies, i.e. following a read-across approach.

Secondly, the effect of the physiological environment of the gastrointestinal tract (including the microbiome) on the formation of NAs from drugs or their degradation products will be studied. Due to the lack of knowledge about endogenous nitrosamine formation, it is of utmost importance to elucidate potential mechanisms in order to reduce the carcinogenic risks for patients. Research findings of these laboratory studies will be integrated and generalized in order to develop predictive QSAR models for the susceptibility of drugs to be nitrosated.

Finally, current bacterial mutagenicity test systems as well as novel in-vitro genotoxicity tests, such as the comet assay in liver cell models (primary human and rat hepatocytes, human liver cell lines), will be evaluated, optimized and validated. Metabolic competence will represent one key topic, to reach the final aim of reliably detecting mutagenicity of different NAs.

 

 

Source:

https://www.item.fraunhofer.de/en/press-and-media/press-releases/mutagenicity-of-nitrosamines.html