Standardized regulation of chemical substances


The industry is continually developing and creating new discoveries, that are more utilized in numerous industries. This market section is characterised by an enormous selection of chemicals, every of which has its own distinctive properties and characteristics. So as to use these chemicals correctly, and most significantly safely, within the work of your company, you wish to possess data concerning what precisely is required for a specific substance. Given the big selection of accessible chemicals that are actively utilized by producing companies, an oversized range of international standards are being created that regulate the necessities for these substances. The fields of application of chemicals are terribly diverse. During this article, we've got centered on two spaces, particularly medical and cosmetic. Medical workers use chemical product resembling antiseptics and disinfectants in their follow each day, thus producing corporations ought to pay enough attention to the regulation of the assembly of those products, since it's concerning the protection of each doctors and patients. The second area that needs regulation for the presence of unsafe components is cosmetic products. As we have a tendency to mentioned earlier, there are several standards in these segments, however, during this article we've got analyzed the foremost basic ones.

Chemical disinfectants and antiseptics - Quantitative suspension check for the analysis of agent or yeasticidal activity within the medical space - check technique and necessities (phase 2, step 1)

EN 13624:2021


For medical staff, sterility is one in every of the most conditions for making certain patient safety. In their work, medical establishments use disinfectants and antiseptics on a day after day to make a secure surroundings for his or her patients. Corporations that manufacture antiseptic product should totally test their product to make sure it works correctly. The required checks and verification technology are delineated within the international customary EN 13624:2021.


This document specifies a test method and therefore the minimum necessities for agent or yeasticidal activity of chemical disinfectant and antiseptic product that kind a homogeneous, physically stable preparation once diluted with onerous water, or - in the case of ready-to-use products - with water. product will solely be tested at a level of 80% or less (97% with a changed method for special cases) as some dilution is usually made by adding the test organisms and intrusive substance.


This document applies to product that are utilized in the medical space within the fields of sanitary handrub, hygienic handwash, surgical handrub, surgical handwash, instrument medical care by immersion, and surface disinfection by wiping, spraying, flooding or alternative means.

This document applies to areas and things wherever 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;

and might occur in the geographic point and in the home. It may also embrace services resembling laundries and kitchens supply product directly for the patients.

NOTE 1 The technique delineated is meant to work out the activity of business formulations or active substances beneath the conditions during which they're used.

NOTE 2 This method corresponds to a section 2 step 1 test.

EN14885 specifies {in detail|intimately|well|very we have a tendency toll|thoroughly} the link of the assorted tests to 1 another and to “use recommendations”.

The international customary that we described on top of can become indispensable for corporations that turn out antiseptics and disinfectants. Its main advantage is that the necessities described in it are often applied to medicine not solely applicable within the field of medicine, however conjointly for everyday life. You'll familiarise yourself with the text of the international customary on our web site victimization the link connected below.


Technique for analysis of allergens - Quantification of an extended list of fifty seven suspected allergens in able to inject fragrance materials by gas natural action mass chemical analysis

EN 16274:2021

The cosmetics business is continually evolving and discovering new niches and opportunities. In parallel with this process, the stuff base increases, and, accordingly, the chance of using such ingredients that may later provoke associate degree sensitivity increases. Therefore, all volatile compounds and every one raw materials that are utilized in production should be tested for the likelihood of allergies. An outline of the strategies that govern the matter testing method is provided within the international customary EN 16274:2021.

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


The analyses coated by this procedure are supported the contents of Tables 13.1 and 13.2 within the SCCS 1459/11 opinion document (1) and as listed in the legislation planned by the Commission. The explanation behind the ultimate selection of procedure analytes is given in the table found in Annex J.


The strategy was valid at IFRA and CEN level.


Knowing the fundamentals that are collected in the said international customary permits corporations to supply a product which will not contain probably dangerous allergens. Considering the very fact that this international document contains an oversized range of tables and informative footnotes, our specialists are perpetually able to facilitate and advise you on these issues.


Chemical disinfectants and antiseptics - Quantitative check for the analysis of disinfectant and yeasticidal and/or agent activity of chemical disinfectants within the medical space on non-porous surfaces while not mechanical action - check technique and necessities

EN 17387:2021


The demand for chemical disinfectants and antiseptics is continually growing significantly. Therefore, producing corporations begin to expand production. At an equivalent time, it's necessary to fastidiously monitor {the quality|the customary} of the merchandise made in order that it provides most protection against microorganism and yeast infections. Antiseptics should be subjected to multi-level checking of their properties so as to be appropriate to be used in medical facilities. The testing technology to be disbursed is delineated well within the international standard EN 17387:2021.


This document specifies a test method and therefore the minimum necessities for disinfectant and yeasticidal and to boot agent activity of chemical disinfectant product that kind a homogeneous, physically stable preparation once diluted with water - or in the case of ready-to-use product - with water.


NOTE Dilutions are necessary as three concentrations within the active to non-active vary are tested.


This document applies to products that are utilized in the medical space for disinfecting non-porous surfaces while not mechanical action.


This document applies to areas and things wherever medical care 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 well the link of the assorted tests to 1 another and to use recommendations.

Victimization this document, it's potential to work out the activity of products like business formulations or active substances on bacterium and/or fungi within the conditions during which they're used and thus it corresponds to a section 2, step 2 test.


This technique excludes the analysis of the activity of products against mycobacteria and microorganism spores.


A feature of this international customary is that it is a continuation of the quality that we have a tendency to thought-about above. This is often the second step in checking the quantitative characteristics of antiseptics, so that they should be utilized in combination. Our specialists can assist you to choose the international standards that are best suited to your business.


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

EN 12353:2021


One in every of the conditions for the assembly of antiseptics is their constant testing for the presence of unsafe organisms. The methodology of those studies involves the employment of check organisms, that successively need correct storage. Every genus of microorganisms has its own characteristics, which suggests that they have specific conditions. Considering heaps of data that relates to the current topic, so as to structure it, the international customary EN 12353:2021 was created.


This document specifies strategies for keeping test organisms used and outlined in European Standards for the determination of disinfectant (incl. bacterium pneumophila), mycobactericidal, sporicidal, agent and agent (incl. bacteriophages) activity of chemical disinfectants and antiseptics needed by CEN/TC 216. These methods for keeping test organisms will solely be disbursed in reference to a minimum of one in every of those customarys wherever a relevance this document is established.


NOTE 1 Annex A (informative) contains a non-exhaustive list of check organisms that this document are often applied.

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

NOTE 3 A specific description on the preservation of microorganism spores might be additional once the results of the continued ring trials are available.


The world standard that regulates the conditions for storage and use of test organisms supposed for the determination of varied styles of activity of chemicals. The most problem with this customary is that it includes an oversized range of chemicals, thus it can typically be troublesome to know it. You'll perpetually ask for recommendation from our specialists.


Cosmetics - Analytical strategies - measure of traces of significant metals in cosmetic finished product victimization ICP/MS technique (ISO 21392:2021)

EN ISO 21392:2021


Cosmetics mustn't contain heavy metals, as they'll accumulate within the organic structure and have a negative result on it. Given the potential threat, all cosmetics ought to be tested for the content of significant metals. So as to qualitatively add this test, it's necessary to know not solely the technology of the study, however conjointly the list of components that may be dangerous. So as to outline of these criteria, the international customary EN ISO 21392:2021 was developed.


- choice of the bronze elements of interest

- choice or development of a reliable method for determination of those elements in cosmetic product that minimizes risk of interferences and permits the acceptable levels to be measured.

- Validation and characterization of the analytical technique to assess its performance (global precision) at the acceptable level.


Corporations that are engaged within the production of cosmetics ought to familiarise themselves with the international customary that we have a tendency to delineated above. because of the data that's placed in it, you'll guarantee the protection of your products. The complete text of the International customary are often found on our web site at the link connected below.

Safety of chemicals utilized in production

The usage of chemical elements in production permits the business to develop significantly. the massive range of chemical components that are out there to the business forces to devote longer to their regulation. New international standards are perpetually being created to assist management the standard and safety of the employment of chemicals in production. There are two market segments that are a lot of active within the use of chemicals in their activities, particularly cosmetics and medicine. Protection of human life is that the foundation that lies in the functioning of any business. we have a tendency to talking concerning each the safety of the tip client and therefore the safety of the staff of the company that manufactures this product. A feature of the creation and manufacture of cosmetics is that there's a listing of drugs that they must not contain, thus as to not cause a threat to the consumer. The foremost dangerous for health are significant metals, which might linger within the body. Another necessary criterion is to regulate the presence of allergens in products. International standards conjointly facilitate makers of chemical antiseptics properly verify the extent of medical care of their product. As we will see, international standards are indispensable documents that are necessary for manufacturers who care concerning their consumers. You can get familiar with all international standards on our website.


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