Standardized regulation of chemical substances

The chemical industry is constantly developing and making new discoveries, which are further used in various industries. It should be noticed that this market segment is characterized by a huge selection of chemicals, each of which has its own unique properties and characteristics. In order to use these chemicals correctly, and most importantly safely, in the work of your company, you need to have information about what exactly is needed for a particular substance. Given the wide range of available chemicals that are actively used by manufacturing companies, a large number of international standards are being created that regulate the requirements for these substances. The fields of application of chemicals are very diverse. In this article, we have focused on two areas, namely medical and cosmetic. Medical staff use chemical products such as antiseptics and disinfectants in their practice every day, so manufacturing companies should pay enough attention to the regulation of the production of these products, since it is about the safety of both doctors and patients. The second area that requires regulation for the presence of unsafe elements is cosmetic products. As we mentioned earlier, there are many standards in these segments, however, in this article we have analyzed the most basic ones.

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)

EN 13624:2021

For medical staff, sterility is one of the main conditions for ensuring patient safety. In their work, medical institutions use disinfectants and antiseptics on a daily basis to create a safe environment for their patients. Companies that manufacture antiseptic products must thoroughly test their product to ensure it works correctly. The necessary tests and verification methodology are described in the international standard EN 13624:2021.

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:

-   in hospitals, in community medical facilities and in dental institutions;

-   in clinics of schools, of kindergartens and of nursing homes;

NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2   This method corresponds to a phase 2 step 1 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

The international standard that we described above will become indispensable for companies that produce antiseptics and disinfectants. Its main advantage is that the requirements described in it can be applied to drugs not only applicable in the field of medicine, but also for everyday life. You can familiarize yourself with the text of the international standard on our website using the link attached below.

Method for analysis of allergens - Quantification of an extended list of 57 suspected allergens in ready to inject fragrance materials by gas chromatography mass spectrometry

EN 16274:2021

The cosmetics industry is constantly evolving and discovering new niches and opportunities. In parallel with this process, the raw material base increases, and, accordingly, the likelihood of using such ingredients that can later provoke an allergic reaction increases. Therefore, all volatile compounds and all raw materials that are used in production must be tested for the possibility of allergies. A description of the methods that govern the allergen testing process is provided in the international standard EN 16274:2021.

The present method permits the identification and quantification of the volatile compounds suspected as allergens, which are present in the fragrance compounds and fragrance raw materials used in cosmetic products. The analysis is performed by gas chromatography and mass spectrometry (GC-MS) on matrix samples which are "ready to be injected" and which are compatible with gas chromatography.

The analytes covered by this procedure are based on the contents of Tables 13.1 and 13.2 in the SCCS 1459/11 opinion document (1) and as listed in the legislation proposed by the European Commission. The rationale behind the final choice of procedure analytes is given in the table found in Annex J.

The method was validated at IFRA and CEN level.

Knowing the basics that are collected in the aforementioned international standard allows companies to produce a product that will not contain potentially dangerous allergens. Considering the fact that this international document contains a large number of tables and clarifying footnotes, our specialists are always ready to help and advise you on these issues.

Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

EN 17387:2021

The demand for chemical disinfectants and antiseptics is constantly growing significantly. Therefore, manufacturing companies begin to expand production. At the same time, it is necessary to carefully monitor the quality of the product produced so that it provides maximum protection against bacterial and yeast infections. Antiseptics must be subjected to multi-level testing of their properties in order to be suitable for use in medical facilities. The testing methodology to be carried out is described in detail in the international standard EN 17387:2021.

This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and additionally fungicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.

NOTE   Dilutions are necessary as three concentrations in the active to non-active range are tested.

This document applies to products that are used in the medical area for disinfecting non-porous surfaces without mechanical action.

This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:

-   in hospitals, in community medical facilities and in dental institutions;

-   in clinics of schools, of kindergartens and of nursing homes;

EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.

Using this document, it is possible to determine the activity of products like commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used and therefore it corresponds to a phase 2, step 2 test.

This method excludes the evaluation of the activity of products against mycobacteria and bacterial spores.

A feature of this international standard is that it is a continuation of the standard that we considered above. This is the second step in testing the quantitative characteristics of antiseptics, so they must be used in combination. Our experts can help you select the international standards that are best suited to your business.

Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity

EN 12353:2021

One of the conditions for the production of antiseptics is their constant testing for the presence of unsafe organisms. The methodology of these studies involves the use of test organisms, which in turn need proper storage. Each genus of microorganisms has its own characteristics, which means that they need specific conditions. Considering a lot of information that relates to this topic, in order to structure it, the international standard EN 12353:2021 was created.

This document specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this document is established.

NOTE 1   Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.

NOTE 2   European Standards (EN) where this document is referenced are listed in the Bibliography.

NOTE 3   A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.

An international standard that regulates the conditions for storage and use of test organisms intended for the determination of various types of activity of chemicals. The main difficulty with this standard is that it includes a large number of chemicals, so it can sometimes be difficult to understand it, in order to avoid this misunderstanding you can always get consultation from our specialists.

Cosmetics - Analytical methods - Measurement of traces of heavy metals in cosmetic finished products using ICP/MS technique (ISO 21392:2021)

EN ISO 21392:2021

Cosmetics should not contain heavy metals, as they can accumulate in the human body and have a negative effect on it. Given the potential threat, all cosmetics should be tested for the content of heavy metals. In order to qualitatively add this test, it is necessary to understand not only the methodology of the study, but also the list of elements that can be dangerous. In order to define all these criteria, the international standard EN ISO 21392:2021 was developed.

Selection of the metallic elements of interest

Selection or development of a reliable method for determination of these elements in cosmetic products which minimizes risk of interferences and allows the appropriate levels to be measured.

Validation and characterization of the analytical method to assess its performance (global precision) at the appropriate level.

Companies that are engaged in the production of cosmetics should familiarize themselves with the international standard that we described above. Thanks to the information that is placed in it, you can guarantee the safety of your products. The full text of the International Standard can be found on our website at the link attached below.

Safety of chemicals used in production

The use of chemical components in production allows the industry to develop significantly. The large number of chemical elements that are available to the industry forces us to devote more time to their regulation. New international standards are constantly being created to help control the quality and safety of the use of chemicals in production. There are two market segments that are more active in the use of chemicals in their activities, namely cosmetics and medicine. It is worth noting that the safety of human life is the foundation that lies in the functioning of any business. We are talking about both the safety of the end consumer and the safety of the employees of the company that manufactures this product. A feature of the creation and manufacture of cosmetics is that there is a list of substances that they should not contain, so as not to pose a threat to the consumer. The most dangerous for health are heavy metals, which can linger in the body. Another important criterion is to control the presence of allergens in products. International standards also help manufacturers of chemical antiseptics correctly determine the level of disinfection of their product. As we can see, international standards are indispensable documents that are necessary for manufacturers who care about their consumers. You can get acquainted with all international standards on our website.

References:

https://standards.iteh.ai/catalog/standards/sist/872236ed-c5c2-4d7d-ba4c-05a1990f08d8/sist-en-13624-2022 https://standards.iteh.ai/catalog/standards/sist/cbc6f6c2-c592-4f0c-8d4e-0ced0d427ccd/sist-en-16274-2022 https://standards.iteh.ai/catalog/standards/sist/aa8ded42-5ac3-4c96-856a-ddc65aa811a7/sist-en-17387-2022 https://standards.iteh.ai/catalog/standards/sist/f8f9b251-49b4-4dcc-a274-f8d5745a35b5/sist-en-12353-2022 https://standards.iteh.ai/catalog/standards/sist/f4b4f6b3-7106-49bf-bfa0-90725be532eb/sist-en-iso-21392-2022