Ashok Pathare Lecture at the Colour Society Annual Seminar By Dr. K. S. Murthy, Pidilite Industries Ltd
THE COLOUR Society featured Mr. Ashok Shreyas N Pathare of Paxchem Limited as one of the speakers at their Annual Seminar at Hotel Kohinoor Intercontinental on 29th July 2016, attended by about 300 delegates comprising industry experts, technocrat entrepreneurs, past presidents, members, academia and students. Mr. Pathare gave an clear insight into the Biocides and preservatives scenario, past present and future Mr. Pathare was also felicitated for his outstanding work, contribution and achievement in his chosen field with the Colour Society Fellowship Award for 2016 on the occasion.
Introducing Mr. Ashok Pathare, Mr. Nirav Raveshia said that he is graduated with B. E. in Electrical Engineering and M. B. A. specialising in International Business from USA. He worked for sometime in industry and returned back to India, joined his small scale family business of specialty chemicals and transformed it into one of the most ethical and reputed MSME manufacturer of Biocides, Preservatives, Anti-Microbials, Disinfectants and Sanitizers in the Indian continent. Disinfectants and Sanitisers bear FDA License certifications and are manufactured in a world class cGMP (ICH Q7a) certified facility. Under his leadership with over 150 specialised products consisting of 25 different applications, they market Biocides to paints (400 companies inclusive of 182 global MNCs) and coatings application areas to 1,200 plus customers in 18 countries, with regulatory and statutory permission. He is the recipient of Entrepreneur Excellent Award and has spoken at conferences with his knowledge of regulatory framework and techno-legal expertise on Biocides and is on Central Insecticide Board & Registration Committee for development of rules and regulations.
Biocides and preservatives scenario: At the outset, Mr. Pathare thanked the Colour Society for the opportunity given to him to make this non commercial overview presentation on biocides to educate people ranging from collegians to heads of companies regarding regulations which are going to affect everybody. If you are going to procure biocide sample for use in paints, thinners, colorants, and export, you need to know regulations. None of the developed countries require the decorative paint companies to register with authorities but the Indian authorities consider that paint manufacturers should register themselves. There is 5-10% charge and they have to register if they are using scheduled pesticide. In the international scenario no paint company procure biocides from unregistered source which is not the case in India. About 70-80 manufacturers of adhesives in India do not even legally exist but sell biocides to paint companies.
Indian manufacturers are going to face regulations in the years to come and the industry is now using the products without any regulation whatsoever but almost all the companies are marketing them based on their technical expertise and knowledge for their market requirements, but this is about to change. Biocides (sooner or later classified as insecticides) formulations are covered under Insecticide Act, 1968 and Insecticide Rules 1971 besides fungicides and weedicides by Central Insecticides Board and Registration Committee. Insecticides are classified in 2 types, technical pesticides TGPs and formulations and implementation done by state authorities. CIB monitors risk to human beings or animals with the use of insecticides and safety measures necessary to prevent such risks.
Biocide Grades: Indian paint manufacturers use biocides of 2 types in percentages of 1 part and the other ranging from 1-4%. Few large scale manufacturers use technical grade pesticides. Almost all paint manufacturers use formulated, undiluted or combination products since there are not many molecules which have preservative properties required by them. Label claim is a problematic area of paint industry. Their products are anti fungal and they are covered by Insecticide Act. There is a phenomenal difference between biocides used in India and internationally who use formulated biocides against high technical or unique products since they have biocide registration mechanisms. Western countries are covered how biocides are manufactured, registered, used and disposed off and that puts additional burden on the paint manufacturers.
Court Orders: Unlike Western world, Insecticide Act in India is challenging with many court cases and court orders which decide what biocides or pesticides are and how the product should be used. No other country has faced so much litigation and court orders to decide what pesticide is and its registration mechanism. The Supreme Court of India remained unchallenged since 2002 and defines biocide or insecticide. Insecticide, pesticide in any shape are defined as insecticide and covered by Pesticide Act. Supplier says his product contains small percentage of biocide and yet it is governed by the act. Though the product is registered in Germany, it is covered by the Indian Insecticide Act.
- Time has come for everyone to understand that we are governed by the act and ignorance of an act is not an excuse.
- Gujarat High Court Order in 2013 says that all the importers of pesticides and insecticides are required to comply with the act, and no specific session referring to registration of the pesticide.
- Similar petition by resale order which says even if you bring a readymade formulation which is basically a biocide that warrants registering technical grade as hazards and risks are decided by the technical. This is landmark and this is how all the biocide companies will decide their future.
- Cochin High Court Order says that certain exemption is allowed for grade use, not insecticide use, but the Central Insecticide Board (CIB) is empowered to control and monitor that usage as well. The onus is on paint manufacture formulator to verify whether or not it has entered our country legally.
Impact of the Court Orders: They directly decide that all the biocides and insecticide formulations are governed by the act. Primary purpose of biocides is to retard, retain, prevail, litigate unwanted microbial growth and fungal growth and such products classified as insecticides.
US FDA differentiates between insecticide and biocide and some of the European countries differentiate definition of biocide, pesticide and weedicide and they have transparent and uniform regulations against all types of products.
The Issue: All the biocides contain scheduled substances and Insecticide Act has a schedule and the products are added to that regularly. Molecules like Diuron and synergy are used in the paint industry and cannot qualify for dual use and exemption. CIB gives exemption only if that particular product does not have prevention and litigation of unwanted growth. Property inherent in the chemical on reacting with something else producing third molecule which does not have biocide properties e.g. bromic acid converted into bromate which does not have pesticide properties and that is called dual use. Apparently, products are imported into India are working empirically under the pretext of dual use when they are not.
Impact of the Court Orders: Paints have high percentage of pesticides and on testing some of the products from the market, up to 6% of scheduled pesticides was found in the paints. If you buy a product 'Good Night' or spray for cockroach which has small percentage of pesticide (0.1-0.7%) and these companies and products had to go through regulations like safety data, hazard data and on the other hand paints using up to 5-6% of scheduled biocides and pesticides do not have such data. We are going to be governed because they contain scheduled pesticide and pose inherent risk and affect our lives.
Time has come not to neglect the issue, to understand and look at it critically. Any scheduled insecticide (diuron or isophthalerein) remains in the can till you apply all the paint on the wall as a substrate and it does not get consumed or evaporated. Diuron leaches out goes somewhere if it is exterior and on washing it goes into the soil. Paint industry consumes over 4,600 tons of diuron per year (in some solvent or air due to excess or incorrect usage). Be aware that it is going to affect biocide people which in turn paint people more.
Situation of biocides before 2015: Court orders passed CIB and health people woke up and regulatory people became aware, safety standards available, raving issues coming in like anti bacterial hand soap during 2014-15 Methicillin-resistant Staphylococcus aureus (MRSA) responsible for several difficult- to-treat infections in humans. Prior to that there were about 8-10 manufacturers internationally who were importing and supplying biocide containing scheduled substances to the paint industry. There were about 70 domestic manufacturers who were mixing biocides by hand ignoring the fact that biocide or pesticide is poisonous. Piracy pesticide was imported as shampoo concentrate, shoe polish and organic compound chapter misused to the fullest extent. Quantum of illegal import till 2014-15 was 1 lakh tons per year. All the Western companies were importing Chinese made material from China relabelled with German, European and Israel code.
Central Insecticide Board: Indigenous manufacturers are neglecting the provision of Insecticide Act which also had a format to maintain stock at the location and none of them were maintaining even 1% as required. CIB came out with bond, realising that many importers were misusing the dual use, law and agriculture use categories to import unregistered, undocumented and unproved insecticide products into agricultural industry. They came across cases where they found expert label of pesticides on the drums where there was no use of pesticides. In 2014-2015, CIB initiated various actions against this illegal import of insecticides. CIB stopped misuse of the earlier issue of import problem and no objection certificate issued by the additional commissioner. They realised that they were given valid permissions but people were going beyond. If they were given permission to bring in X, people were bringing X + 2 YZ i.e. 5,000 tons against 1,000 tons. Authorities stopped production of India's one of the largest biocide manufacturers (subsidiary of a well - known European company) who violated customs act and insecticides act. This is the turning point when people woke up and realised that CIB is going to stop their operations.
Role of CIB: Discipline proposed paint industry that was not happy with the guideline from no regulation to excess regulation that each paint company had to spend between 30 lakhs to 2 crores whether small or large and to develop the data CIB asking for. Each biocide company would have to stay between 3 crores to 25 crores to generate this data. The industry and Indian Small Scale Paint Association submitted substantive objection with documentary evidence and guidelines kept on hold. CIB formed expert committee to draft new guidelines. It also commenced a system (interim policy) of import products and manufacturing products. The industry is not very happy with it and they are making the industry some extent allow some guidelines for import and local manufacturing. CIB has issued import and manufacturing service to local biocide company and foreign biocide manufacturing. The expert committee is benefitting the issue of new guidelines and hoping for consensus and draft rules in few months.
Present Statutory Situation: Right now you have the import permits issued though they are challenged with Appellate Authority Secretary, Ministry of Agriculture. It is claimed that local manufacturers, import permits are giving undue advantage to the foreign manufacturers whereas Indian companies are required to buy from recognised and registered body but the imported companies can still go to China, buy duplicate cheap low cost product and send to companies here. CIB asked the expert committee to look into crux of the problem of registered source within next 30 days. What constitutes registered source or approved source and for toxic, why that material has biocide or pesticide, both are the key issues. Secretary of Ministry of Agriculture said all the imported products will be rejected overnight thereby industry will have serious consequences and supplies are not going to be assured. Maintaining CIB register, technical people are not happy with them as paint industry chapter. It rises to be 70-80% more than the comparable challenge for them. Paint industry takes it strongly with CIB that they feel there is excess profit margin. Indian suppliers are 70- 80% higher than the Chinese or Asian suppliers.
Possible Regulations: Understand what regulations are coming. All the biocide manufacturers will have to comply with Insecticide Act. Manufacturers, suppliers and importers will be complying with the Insecticide Act starting from 3 months ago when the trade started.
- All the paint companies will have to comply with the pesticide regulations and Insecticide Act. Paint industry will be given some additional time by CIB for understanding to comply and to be ready.
- Both biocide formulation and paint formulation will have to generate appropriate toxicity, efficacy and medical data to conform safe use.
- Paint MSDS is generated using a software and that won't do. Develop toxicity, efficacy and medical data.
- There is a possibility that CIB will modify the registered data requirements of biocides and say these are agro formulations. This will reduce the data, which is 1/3rd of agro chemicals.
- Glycol based preservatives are not in the schedule of act e.g. ZPPE, IPPC, DCAIT and as such manufacturers are happy that they do not have to register these products. However, CIB proposed to include all these products in the schedule as they are in the schedule of the developing countries and India is the only exception.
- All the biocide formulations containing scheduled insecticides have to follow formulation, indigenous manufacture registration under pesticide act. There is a clear guideline to register your formulation and the biocide manufacturers have to prepare themselves and start with registration. They have to procure the technical data direction and no more unregistered or unknown products. For all the products, the source has to be registered with CIB and also the foundation.
- Inputs of biocides based on unregistered sources may not be permitted. 90% of imported products in India are from unregistered source.
- Inputs of unregistered formulations will not be permitted and that means technicals have to be registered and also formulations.
- About 60% of market consumption is from imported biocide and the rest is controlled by indigenous manufacturers.
Regulations of Paints: Label claims that paint is anti-fungal, anti-mildew are going to be bound by CIB. It is not going to be open tank that the paint is antiseptic and insect control is not going to happen anymore. This will affect some large companies. CIB intends to restrict the use of technical by the paint manufacturers. Paint companies may have to procure biocides only from CIB registered sources. Just as biocide manufacturers have to procure their products from CIB registered source, paint companies will also have to follow suit.
- The usage of biocide which control scheduled insecticides in the final stage may be monitored or restricted by CIB.
- For members, IPA recommend 3% and ISSPA 2-2.5% will make the percentage usage much less than what is currently possible.
- Specialised paints such as insect controlled paints and marine paints with specialised trade will have to register with CIB.
- Import of readymade paints containing unregistered biocides may not be possible. This is not the key area and affects domestic industry.
- Paints imported into the country which already contain pesticide, biocide may not be allowed once the regulation takes effect.
Industry experts' recommendation: Evaluate biocide supplier readiness to comply with the Insecticide Act for the present and future statutory compliance. Do not assume anything; ask them how they intend to take care of things.
- In a typical case, CIB had issued import permit telling the importer that he cannot be allowed use of biocide more than 20 or 7 or 1%.
- Manufacturers are selling to the same companies without following the dosages, which is against the law. The company and also biocide manufacturer will be in trouble. So look at the quantities and permissible dosages.
- Companies using technicals should be included in the schedule. Do not accept that this is OIT example 2-n-Octyl- 4-Isothiazolin-3-One and develop that product as your choice of biocide assuming it is not going to be in the schedule. So do not approve expensive or special product. Visit CIB for they have a PRO, Information officer and confirm everything. Do not believe anything which does not sound logical or truthful.
About Paxchem Ltd: Paxcem started in 1977 and was the first chemical company to approach CIB in 1994 and worked for 2 years to get their consent and exemption. They imported, procured, formulated and exported a variety of biocide formulations including scheduled products to paint companies. Local companies are changing biocide exports to 80%, CIB allowed the NOCs to continue including their own NOC. They have complied with CIB based requirements for technical grade pesticides and formulations under Section IX. They are backward integrated and have created infrastructure, which is independent of international scenario. They have in-house production capabilities of specialty additives required for formulation with control of quality, testing facilities from start to end and product documentation. CAS numbers of ingredients are made known as they believe in transparency. Capacity is 2,000 tons for paint industry and 30 other industries. They have more than 150 biocidal formulations of which 60 are catered to paints, coating and printing inks industries. Their team mission 'Intelligent Preservation Solutions – To Protect Your World' .