Introduction
For regular and simplified registrations under MEE Order No. 12, applicants who intend to apply for protection of chemical substance identification information (including Chinese and English names, CAS numbers, molecular formulas, structural formulas, etc.) shall submit a statement of necessity for information protection. If the confidentiality application is finally approved by the authority, the information in the publicity/announcement and registration certificate, as well as the final listing in the IECSC*, will only reflect the generic name of the substance, and will not reflect the specific substance name, CAS number, and other identification information. *: Only applicable to new chemical substances that have obtained a regular registration certificate, which will be listed into the IECSC by the MEE after 5 years from the date of first registration. According to the Measures for the Environmental Management Registration of New Chemical Substances (hereinafter referred to as the Measures), the necessity statement for information protection shall explain whether the information to be protected has commercial value, so as to prove the necessity of applying for information protection. REACH24H has accumulated rich experience in regular and simplified registrations. We have found that this part is the focus of the authority's review process and largely determines whether the information protection application can be approved. For applicants, this is also the most difficult part of explaining the necessity of applying for information protection. Today, we will talk specifically about how to explain that the identification information of the substance applied for has commercial value. The Measures provide some guidance on how to explain commercial value: In short, it is necessary to explain that the identification information of the substance applied for confidentiality is a trade secret and has a substantial causal relationship with its market value. Based on past project experience, REACH24H will share the following four aspects:
R&D Background
Explain the R&D purpose of the substance. According to the use of the substance, combined with its advantages in function/use/market, explain the market value and development prospects of the industry in which the substance is applied, and indicate the necessity of market activities and R&D of the substance.
Example 1
The substance is a pesticide intermediate used to synthesize a new pesticide, which is expected to have excellent market competitiveness and huge market value due to some rare characteristics/advantages. The advantages of the substance over other competing products are lower toxicity/greatly optimized synthesis process/increased yield, etc.
Example 2
The substance is a performance regulator for a material that has a huge market demand, but its further development is constrained by performance defects in some aspects (e.g., heat resistance/degradability/flame retardancy, etc. that do not meet the requirements of the application scenario), and the substance can significantly enhance and improve the performance defects of the material, thus optimizing material performance, promoting market development, and having great market potential. It is recommended that enterprises conduct sufficient market research on the expected application industry of the substance, and try to quantify the market value and development prospects of the industry with specific values.
R&D Cost
Quantify the R&D cost of the substance with specific values, including the labor cost of researchers, the purchase/consumption/management cost of instruments/equipment/materials used in the research, and the R&D time cost, etc., to show the great effort and huge time and economic cost paid for the R&D of the substance.
Economic Value
Combined with industry and market conditions, assess the annual sales and net profit of the substance in the international/domestic market, and quantify the economic value and market benefits that the substance may bring to the applicant with specific values.
Example
The registration volume of the substance for regular registration is *** tons/year, and the sales unit price in the Chinese market is expected to be ***, so the annual sales under the regular registration activity volume is expected to be ***, and the future revenue is expected to reach ***.
Commercial Value of Identification Information
The applicant needs to select 1-2 or more of the most important structural information from the identification information of the substance for confidentiality application, and fully demonstrate its association with the use, production process and other commercial secret information of the substance, as well as its substantial impact on the commercial value of the substance.
Example
The substance is a polymer, and its name contains information on the reaction raw materials required to produce the substance: polymerization monomers A and B, reactant C, and end-capping agent D. Monomers A and B are common polymerization monomers, while reactant C and end-capping agent D are structural control components added to optimize the performance of the polymer. Therefore, the applicant chooses the key information of reactant C and end-capping agent D for information protection application. At the same time, the polymer name also directly reflects its synthesis process. If disclosed, competitors can conduct imitation development. If the imitation is successful, it will affect the market competitiveness of the substance, thus causing economic losses to the applicant. For the commercial value of the identification information of the substance, the applicant needs to have an in-depth understanding of the performance advantages of the substance and the market conditions of related industries, and provide a full explanation in combination with the R&D purpose and R&D cost of the substance. At the same time, the relevant industry value, economic benefits, R&D costs, etc. should be specifically quantified into numbers to directly reflect the substantial causal relationship between the identification information to be kept confidential and the commercial value. In addition, according to the Measures, the necessity statement for information protection shall also analyze and explain whether the information to be protected is known to the public, including:
Whether the information applied for protection has appeared in advertisements/propaganda materials, publications, public patents/literature, databases, Internet and other related public materials or media or not; whether it is related to the applicant’s enterprise information and is available for the public or competitors
Whether the information applied for protection has been published or disclosed by the competent departments of ecological environment or other competent authorities at home and abroad or not.
Therefore, if it is already known that the identification information of the substance meets the above conditions, the possibility of the confidentiality application being approved is very small, and it may even be directly denied information protection. To ensure the smooth progress of the registration application, avoid unnecessary review supplements, and shorten the registration cycle, it is also recommended that applicants check in advance whether the identification information of the substance is included in public materials, media, and the publicity/announcement information of competent authorities before registration, and carefully decide whether a confidentiality application is needed. The following are some situations where the possibility of a confidentiality application being approved is small, for reference by enterprises:
The applicant's official website contains information related to the substance
News media reports on the applicant's production/import of the substance, and reflects the identification information of the substance
Multiple public databases have listed the applicant as a supplier of the substance
The identification information of the substance has been included in the inventories of multiple countries/regions
