Interview with Mr. Alex Wu, Senior regulatory consultant of Agriculture and material Division (AMD) in Reach24h Consulting Group.
Q1. As we know, REACH24H Consulting Group is a famous global independent consulting company. Could you please introduce more details about what services REACH24H can provide to customers?
Founded in 2009,
REACH24H is an internationally renowned technological services company with headquarter in Hangzhou, China and branches at Dublin in Ireland, Virginia in United States, and Taiwan. By creating a 24-hour global consulting service network and a technical expert team, REACH24H provides one-stop international market entrance services. Our services cover a broad range of industries such as industrial chemicals, agrochemicals, cosmetics, food and food contact materials, and consumer products. Service content includes product notification and registration, regulatory information, news and compliance warning, training seminars and open courses, as well as internet-based supply chain management software.
Agrochem & Material Division (AMD) of REACH24H Group, is a leading provider of regulatory consultancy services, market investigation, scientific and technical support to the industries of crop protection, plant nutrition, biocides & disinfectants as well as food contact materials. Over 80% of our regulatory experts have masters or doctoral degrees in biology, agriculture, chemistry, toxicology, environmental sciences and so on, and skilled in the use of English & Chinese in customer service. Most of them with extensive experience of negotiating with different regulatory authorities, provision of regulatory advice in line with current regulatory guidelines and stewardship of dossiers through the evaluation process.
AMD of REACH24H has the capability to advise and identify a regulatory strategy for successful registration. Undertaking data gap analysis and project management from start to finish, the group also has in-depth experience with organization and planning of regulatory projects and dossiers. Be confident knowing that our regulatory capabilities span AP, EU, NAFTA, LATAM etc.
Q 2. What makes REACH24H stand out from the competition?
“Value in Compliance” is REACH24H’s mission statement. REACH24H has provided technical supports for governments, associations and social organizations, served over 6,000 well-known companies and completed tens of thousands of projects from product notification, registration to consulting. To remove trade barriers and promote global trade integration, REACH24H has offered outstanding technical services.
As a people based business, we always ask ourselves two questions to improve our services. One is what is more that we can deliver to our clients than other competitors, and the other is if our competitor is offering the exact same product, how ours are better.
For first question, REACH24H has already built strong relationships with local labs, so that we can devote ourselves to regulatory studying, professionalism enhancing, product developing, information providing, and service improving. Specialized and professional, REACH24H always try to offer the most considerate and comprehensive solution for our client. Professional, also innovative, we have developed several self-brand products and are keeping on developing.
With respect for second question, REACH24H believes capability is a key to achieve excellence, and the way we deploy it is of the same importance as our capability. Thus, we require and guide our staffs to follow REACH24H’s code of conduct and performance values. We invest in people to improve our capability as well as our way to work. We also attach great attention to internal controls for protecting the reputation of our clients as well as our own.
Bearing both in hearts, we keep researching in depth on a wider range of chemical and chemical-related legislations, and intend to develop more convenience-providing products like ChemLinked Agrochemical Portal. We also keep on training our staffs and professionals, and absorb new talents into our team, and go the extra miles every time for our clients. For the competitiveness of REACH24H, we strive every minute to perfect our services.
Q3. So, what is ChemLinked Agrochemical Portal? What kinds of resources can be found by this platform?
ChemLinked Agrochemical Portal is a one of a kind, multilingual platform providing comprehensive regulatory compliance information and registration services. At ChemLinked Agrochemical Portal we leverage our geographical and language advantages to bring customer unparalleled access and up-to-the-minute coverage on Chinese crop protection issues all backed by a comprehensive regulatory database. ChemLinked Agrochemical Portal is an encapsulation of the fundamental principles we follow. By this platform we act as a bridge connecting foreign and domestic interests with the information and services they need to comply with regulations and access China’s lucrative markets. We believe that successful market access is supported by the pillars of reliable, timely and high quality regulatory information and solid experience in successful application of practical registration procedures.
In addition our ChemLinked Agrochemical Portal can boast a wealth of resources available in our: 1)
AgroPedia - Wikipedia-style webpages covering all the essential regulatory issues on pesticide, fertilizer and biocide in China, Brazil and Myanmar, etc; 2)
Agro Law (Regulatory Database) -Unique and comprehensive collection of pesticide regulations and standards in emerging market especially China; 3)
E-book -English translation of Pesticide Regulation and tailor-made market report; 4) One-to-One Expert Consultation Services and so on.
Q4. We learned that more and more Chinese enterprises are going to enter the EU market in recent years, what do you suggest about the EU registration of pesticides?
In Europe, the approval of active substance normally requires 2 to 4 years. However by demonstrating that the alternative source of active ingredient has the same or less harmful effects (taking into consideration of impurities) when compared to the reference source, the technical equivalence assessment enables the entry of generic technical product into the EU market in a costless and efficient way.
During the equivalence assessment between the reference source and the new source, a two-tiered approach will be utilized. Tier I will evaluate chemistry data, including manufacturing process and technical specification with supporting five batch analysis on representative batches and validation data. If the equivalence cannot be concluded at this stage, the assessment will proceed to Tier II, which involves further consideration on mammalian toxicity and eco-toxicity profiles.
The time duration of the equivalence assessment would vary from 8 to 12 months, depending on the policy of the Rapporteur Member State (RMS) selected, technical skills, number of pending dossiers and workload of the authority, etc.
On 11 Aug 2017, the UK competent authority, Chemical Regulation Directorate, Health and Safety Executive (HSE) concluded that a new source of fluroxypyr origin from China is technical equivalent to the current reference specification for the active substance under Regulation (EC) 1107/2009 (the EU Plant Protection Product Regulation). The application for the technical equivalence (TE) assessment was submitted by REACH24H, a leading regulatory consulting company in China, on behalf of a Chinese pesticide manufacturer. In this submission, REACH24H produces the fastest record of only 7 months with a Tier II assessment.
Q5. What do you suggest for the overseas pesticide companies that want to enter the US market?
United States pesticide law and regulations are complex and can be confusing to companies from other countries. EPA separates pesticides into three general categories, such as conventional chemical pesticides, bio-pesticides and antimicrobial pesticides. Based on which type of pesticide is being reviewed for a pesticide registration decision, different divisions of EPA’s Office of Pesticide Programs will evaluate the action, and the data requirements for registration will vary. The US regulates antimicrobial products, such as disinfectants and sanitizers, as pesticides under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). Different subcategories are also distinguished under the three category of main registration categories. Therefore, the applicants who want register the products in the United States are very necessary to accurately determine the category of the registered products in order to avoid waste of time and expenses.
In addition, EPA requires that foreign manufacturers wishing to register their products for distribution and sale in the US appoint a US agent to act on their behalf. So it is essential to choose an American local agency with experience and strength. Such a consulting organization can help enterprises to fully communicate and communicate with EPA at all stages of registration projects, so as to ensure the smooth progress of registration projects.
At present, both pesticide produced in the US and imported from abroad are increasing rapidly year by year. The US is getting more rigorous about pesticide management which causes more and more pesticide enterprises to pay attention to the pesticide compliance. REACH24H has rich experience in EPA pesticide regulatory compliance and there is a professional team engaged in this field. As a skilled service provider, REACH24H can answer your questions professionally and offer solutions to you.
Q 6. The new Chinese pesticide regulation, "Administrative Measures for the Registration of Pesticide” has been released on June 20, 2017. The greatest change shows that it will be mandatory for applicants to provide Risk Assessment Report of the pesticides they intend to register when companies submitting final dossier under new regulation. Do you have any suggestions on how to prepare the registration data for the pesticide risk assessment Report?
There is no doubt it will take great challenges to potential applicants, after all, Risk Assessment Evaluation is not required in the old regulation. It will require relatively professional technology when carrying out Risk Assessment because it should be based on scientific data and models under specific conditions, and it aims to scientifically evaluate the possibility and severity of adverse effects of pesticides on human health and the environment.
Risk assessment is based on scientific data and models under specific conditions and aims to scientifically evaluate the possibility and severity of adverse effects of pesticides on human health and the environment.
According to different target populations, health risk assessment is mainly divided into “Occupational Health Risk Assessment”, “Residential Health Risk Assessment” and “Pesticide Residue Risk Assessment”. “Occupational Health Risk Assessment” is mainly to evaluate the health risk to the pesticides users in the process of pesticide mixing and pesticide application. “Residential Health Risk Assessment” is mainly to evaluate the health risk to residents in the process of using aerosols and repellents. “Pesticide Residue Risk Assessment” is used mainly to scientifically evaluate the health risk to the humans after eating agricultural products containing pesticide residues.
Environmental risk assessment is used to predict the risk posed by pesticides to organisms in different niches of the ecosystem. The environmental niche is subdivided into “Freshwater Compartment”, “Terrestrial Compartment” and “Air Compartment” Evaluation in different environmental niches requires different target organism. For instance, fish, Daphnia and algae are usually selected at three trophic levels as target organism for the evaluation of aquatic ecosystem in freshwater compartment.
The risk of pesticide application to human beings and the environment is directly related to the hazard characteristics of pesticides and the exposure of the target population. The magnitude of the risk is represented by the Risk Quotient. If the value of Risk Quotient is less than 1, the risk is controllable. Otherwise, the risk is not controllable.
We have already hold a webinar to offer a better interpretation on the new requirements of pesticides Risk Assessment on Sep 13th, 2017, the mainly contents covered the following topics: 1 ) relevant legal requirements for pesticide risk assessment; 2) categories and related concepts of pesticide risk assessment; 3) How to prepare a pesticide risk assessment report? ; 4) What REACH24H could do to assist applicants to complete a pesticide risk assessment report? We are very willing to help more customers to read these problems in depth by this way.
Alex Wu
Senior regulatory consultant of Agriculture and material Division (AMD) in Reach24h Consulting Group
Email:
wudapeng@reach24h.cn
TEL: +86 571 87007520