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Disinfectant

Disinfectant (7)

The European Union authorisation is a new form of authorization which was recently introduced into the EU Biocidal Products Regulation (BPR), promulgated on 1st September, 2013. Based on the new article, this Union-level authorization will allow products to be sold in all EU countries at one same time. This will simplify the assessment of applications and reduce the cost and time required compared with the reporting route of obtaining national authorizations in multiple member states.

Based on practical experience, the reasons for selecting union authorization are as follows:

1. Harmonised assessment across EU countries

While national authorisations are managed by Member States independently, Union authorisations will be managed by ECHA, with the final decision coming from the EU countries and the European Commission. The Union authorization will initially simplify the process by ensuring coordination along member states, and eliminate the workload of having to repeatedly explain the authorized products to multiple countries. What is more, the intervention of ECHA not only promotes communication and coordination, but also urges the completion of the deadline of each stage, which undoubtedly plays a crucial role in the normal launching of the applicant's products. Union authorisation ensures that the product information received by customers within the EU is consistent and clear.

2. More economical for multinational markets

Whether or not to choose Union authorisation depends on the actual situation of the company. If a company needs or is prepared to launch products in 10 or more EU countries, applying for Union authorisation for a product can greatly reduce the economic cost of obtaining individual national authorisations.

3. Close cooperation with authorities

The applicant should select the appropriate member state to act as evaluating authority, fully communicating the requirements of the authority to prepare the corresponding dossier. The working groups of the Biocidal Products Committee (BPC) will draw conclusions on the adequacy of the application and experts from each member state will facilitate the harmonization of assessments. The final decision will be taken by the European Commission and Member States. During this period, support from ECHA is available through each step. Some companies expressed they were given full guidance from ECHA when they applied for Union authorisation.

4. Innovating with a product family

The introduction of Union authorisation for a family of products can help a company innovate and launch new products more easily. For example, a product family consisting of several similar products can be authorized to obtain a Union authorization of all products through the authorization of a single product family. The enterprise can then set different formulations for different markets or develop new formulations for specific markets. The company can create different formulations for different markets, or launch a new formulation for one market.

Of course, the biggest challenges of union authorisation are timelines and fees. Generally speaking, the preparation of declaration can take 2-3 years and the official assessment cycle about 3 years. In terms of fees, the administrative fee for union authorisation to ECHA is over 40,000 euros. Applicants are also required to pay assessment fees to the evaluating country in accordance with the fee standards of each member state. Data charges are also a big expense. Therefore, the authorization before declaration should be based on the product market and company planning, to assess the economic costs. Secondly, if the company applies for a Union authorization, the declaration plan should be well planned. Third, keep close communication with the evaluating authority, and seek the support of experts on issues such as risk assessment and efficacy. Finally, if a Union authorization is finally obtained, the products will be put in any EU country by means of a simple notification.

REACH24H CONCULTING GROUP CHINA is regularly following up on the regulations of European biocides and will continue releasing the most updated information. We recommend that in order to ensure an orderly and responsible product authorization, companies with business within the EU market stay up to date on the latest developments.

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Abstract: The health safety evaluation report is the most important review basis for disinfection products in China. Therefore, foreign enterprises should pay more attention to some key points in order to avoid administrative penalties from the Public Health Authority.

When it comes to the final review of Health Safety Evaluation Reports for Disinfection products, there are a number of key points that are often overlooked, and which may determine a Report’s rejection, or even subject it to penalties from the relevant Health authority. Below, AMD Technical Team has summed up some key issues to take into account:

1)       The Subject indicated in the Health Safety Evaluation Report must be the Chinese production company or responsible legal entity in China for the imported product.

2)       The content of the Health Safety Evaluation Report should include all of the following: label, specifications, test report, enterprise standard or product quality standard, hygiene license of the domestic product manufacturer, certificate of production and sale in country of origin for imported product, product formula for disinfectant, main components and structure chart for disinfecting apparatus.

3)       The Health Safety Evaluation Report should be valid in the whole Chinese territory. The period of validity of Class I disinfectant products is four years, while Class II disinfectant products have a longer validity period.

4)       The Health Safety Evaluation Report should be re-registered prior to the expiry date for Class I disinfectant products. When testing disinfection products, only key projects will be done. For example, active ingredient content, pH value and one of the most resistant microbial killing tests for disinfectant, main bactericidal factor strength and one of the most resistant microbial killing test for disinfecting apparatus.

5)       Tests will have to be retaken in the following cases:

 

Test items

Disinfectant

Disinfecting apparatus

Factory is relocated

Active ingredient content, stability test, pH

Main bactericidal factor strength

Branch factory or workshop is set-up

Expiration date is extended

Active ingredient content, pH, one of the most resistant microbial killing tests and stability tests; if use original test sample, only stability test is required.

/

Scope of use or change the method of use is increased

Physical and chemical testing, microbial killing test, toxicological test


6)       Lastly, the testing of disinfection products should be carried out in labs that hold the corresponding CMA (China Metrology Accreditation) qualification. The report will require the CMA mark.

Tuesday, 25 September 2018 09:14

EU to Make More Information on Biocidal Products Available

Written by AMD

In November 2018, The European Chemicals Agency (ECHA) will offer more information on biocidal products on its website. The improved interface will make the product’s trade name, use type, authorized holder, authorization start and end date, assessment report and other information associated to the authorized product available.

Website preliminary model of

This move by ECHA is aimed to improve transparency in the process of compliance, to some extent serving as a tool for market oversight and compliance promotion, although there is a potential risk of data being leaked. To this end, ECHA, EU Member States and applicants will have to reach consensus as to what is considered “non-confidential data”. Initially, when submitting an application, the applicant will have to determine the level of confidentiality for all their data. Later on, when the assessment is coming to an end, the applicant will have to make said information public. The authorized evaluation authority will be responsible for checking the confidential and non-confidential information of the product assessment report in the final stage of the evaluation.

The competent evaluating authority is also responsible for reviewing and ensuring all information on an authorized product to be made public is available by September 30, 2018. The company should actively communicate with this authority, complete all requirements –such as modified document name–and make it clear that the information to be published does not include any confidential information pertaining to the company.

Abstract:Introduction to Antibacterial (Bacteriostatic) products in China as disinfectants and their distinction from regulated drugs

According to the Chinese Catalogue of Disinfectant Products, disinfection products include disinfectants, disinfection equipment and sanitary products. Sanitary products are one of the most commonly used disinfectants in our daily life, such as tissues, wet wipes, feminine wipes, diapers, antibacterial (bacteriostatic) products, contact lens solutions and so on.

Antibacterial (Bacteriostatic) products are a type of disinfectant which are in direct contact with human skin and the mucous membrane, and consequently cause a specific bactericidal effect. Products of this sort may reduce bacterial infections on the human body and keep the body germ clean and hygienic. Common antibacterial (bacteriostatic) products include skin antiseptic ointments, women's anti-bacterial lotions, anti-bacterial hand sanitizers, and anti-bacterial mouthwashes, among others.

Key characteristics of Antibacterial (Bacteriostatic) products which differ from regulated drugs:

✔ Domestic products are marked with "消证字号": (For example: 浙卫消证字(2018)第1234);

✔ Range of use is limited to human skin or the mucous membrane;

✔ Products have antibacterial or bacteriostatic effect.

Misconceptions regarding Antibacterial (Bacteriostatic) products

Antibacterial (Bacteriostatic) products are in their essence different from drugs and they have no effect on the treatment of diseases. It is not advised that they be used as a replacement for medical drugs, since their use may even delay recovery from an illness. This applies even to antibacterial products purchased from drug stores.

Wording on Antibacterial (Bacteriostatic) products cannot be confused with drugs

✔ Labels and instructions of antibacterial (bacteriostatic) products are prohibited from stating various disease names and disease symptoms, such as "psoriasis"," neurodermatitis ", among others;

✔ In the scope of use and methods of use, antibacterial (bacteriostatic) products are not allowed to claim similar effects, use doses and objects as drugs without a test basis, such as "X times per day", "XX days as a course of treatment, or following doctor's advice", etc.

Therefore, it should be clear that antibacterial (bacteriostatic) products are regulated as disinfection products and not as drugs, as they are regarded as having only an antibacterial or bacteriostatic effect. Labels and advertisements can be misleading, promising to cure illnesses, so consumers should stay vigilant and aware of this relevant distinction to avoid compromising their health.

Abstract: Foreign enterprises of disinfection products should pay attention to key some points before entering the China market

Recently, Reach24h Group helped another international disinfectant enterprise giant finished the hygiene and safety assessment of the two products in Jiangsu province, China. Along with the quick development of China's economic, the capacity of Chinese disinfection products market is growing dramatically. However, foreign disinfection products may be not allowed to be sold in China if they do not meet the China regulatory compliance requirements. Here is some key points of registering  foreign disinfection products in China market.

Firstly, disinfection products without permission of production and sales in country of origin are not allowed to enter into China. And the products should be also used as disinfection function for human skin and mucosa, environment and others in Catalog of disinfectant products 2002 published by National health and family planning commission (NHFPC), but not medical and veterinary drug  uses.

Secondly, for foreign exporters, they should have a Chinese responsible party for their product registration and market in China. It can be its distributor or branch office.

Thirdly, hygienic safety evaluation of product should be qualified before marketing in China.

Foreign enterprises who are not familiar with China Hygienic Disinfection Product Regulation should get professional consultations before entering the China market, to avoid wasting time and money.

Abstract: Shanghai Municipal Health Commission continues to strengthen the supervision on disinfection products and make the 2018 disinfection product supervision spot check plan.

According to the requirements of the National Health Commission, Shanghai has drawn up a plan for the randomized inspection and spot check of disinfection products in 2018 to manufacturing enterprises and operation units.

According to the requirements of the National Health Commission, this year's randomized inspection and spot checks will be conducted in two stages: the first half of the year and the second half of the year.

This year's randomized supervision and spot check of disinfectant products will continue to be problem-oriented, based on the “double random” inspection method, strengthening the inspection of disinfectant products, strictly implementing the main responsibility of the company for product health and safety evaluation. In 2018, it will focus on the inspection of the first and second types of disinfection products with a relatively high degree of risk, new registered product, and products that have failed in spot checks in the past.

In the first half of the year, Shanghai focuses on checking the business licenses information, the content of the labels and instructions, bill checking and the in and out storeroom records. The inspection results show that the overall market of disinfection products in Shanghai is in a good situation, and most of the business units are able to comply with the provisions of the “Disinfection Management Measures” and legally carry out the production and sales of disinfectant products.

In the second half of the year, according to the requirements of the National Health Commission, Shanghai will also carry out spot checks on 84 disinfectants and infant use hygiene products (wet wipes, hygiene wipes, diapers, etc.).

Thursday, 29 March 2018 08:35

Supervision of China's disinfection products is on the way

Written by AMD

[Abstract] Officials in China increase supervision efforts on disinfectant products to improve market order and protect peoples’ health.

Within the classification of Chinese disinfection products, one type of disinfectant is used for disinfecting the skin and mucous membranes. Although this mucosal disinfectant is only intended for use at medical institutions, there have been cases recorded of illegal use by enterprises that take advantage of consumer’s low awareness of the distinction between disinfectants and medicine. This has led to the use of disinfectants instead of regular medicine, which endangers the health of consumers. In 2018, in order to crack down on the illegal production and sale of unqualified, counterfeit disinfectants as well as to improve government oversight and protect consumers' health, law enforcement officers from China's Provincial Health Supervision Institute have begun conducting spot checks in stores offering medicinal, maternal and infants well as hygiene products.

The human epidermis, especially children’s, is susceptible to irritation. At present there is a wide variety of skin and mucosal disinfectants  on the market, yet the product quality greatly varies across manufacturers, especially when it comes to infant skin care products, such as disinfecting wipes and other hand and skin disinfection products. Moreover, common issues tend to arise at the verification stage. For instance, some operators do not request the valid certificates and product safety reports from manufacturers when they purchase disinfection products; some labels may even wrongly claim therapeutic effects, while others fail to present all necessary information.

In response, law enforcement officers are now more frequently visit establishments to issue inspection reports, take products found to be non-compliant off the shelves as well as request certificates for on-sale products to ensure they do not pose any danger. In the next stage, the Health Inspection Department will establish a normalized monitoring mechanism for disinfectants to further improve the management of operators, standardize the market order of disinfectants, and safeguard the health and safety of the Chinese people.

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