A Comparative Review of Biocidal Legislation in the EU, US and Canada

Prepared by: Jerry Miller, Senior Regulatory Consultant, Compliance & Risks

October 2020

1. Introduction 2 2. Biocides 2 3. Antimicrobials 4 4. Textiles 5 5. Biocide Regulations 6 6. European Union 7 6.1. Approved Substances 7 6.2. Treated Articles - Article 58 8 6.3. Labeling 9 7. United States 10 7.1. Approved Substances 12 7.2. Treated Articles 12 7.3. Labeling 13 8. Canada 14 8.1. Approved Substances 15 8.2. Treated Articles 15 8.3. Labeling 16 9. Comparison of EU / US / Canada Legislation 17 9.1. Similarities and Differences 19 10. Companies 20 11. Conclusion 21 12. Sources 22 About the Author 24 About Compliance & Risks 25

1. Introduction

What is a treated article? In layman’s terms, it’s an item that has been manufactured with a specific type of biocide to protect the item from staining, bad odors, or premature material degradation caused by microbial or bacterial growth. Treated articles use a variety of synthetic or natural chemical biocides to achieve this effect, the particular biocide is based on the organism they are trying to eliminate or control.

Treated articles include a wide variety of consumer products, such as clothes (e.g., t-shirts, athletic gear and jeans), toys, kitchen utensils, computer products, window cleaners, chopsticks and bed clothing (e.g., pillows, sheets, towels and slippers), as well as a wide variety of plastic products.

The focus of this paper will primarily be on consumer / domestic goods such as textiles and housewares goods that have been manufactured with some type of biocide. However, countries regulate biocides differently. The secondary purpose of this paper is to compare and contrast how these treated articles are regulated in the European Union (EU), United States (US) and Canada.

Treated articles sold in the EU, US and Canada can fall under multiple regulatory agencies depending on the individual country legislation, the specific product and the purpose of the treatment/product. In the US, cosmetic products would be regulated under both US EPA and FDA regulatory agency regulations as an antimicrobial or preservative. In the EU, cosmetic products have their own Directive which addresses preservatives as well as chemical legislation for biocides. Canada’s regulatory structure more closely follows the US approach. For example, The Pest Management Regulatory Agency (PMRA) regulates disinfectants through the Pest Control Act (PCA) and the Pest Control Products Regulations. The Natural and Non-prescription Health Products Directorate (NNHPD) regulates disinfectants through the Food and Drugs Act and the Food and Drugs Regulations.

2. Biocides

A biocide is defined in the EU as an active chemical molecule that controls the growth of or kills a specific organism, i.e. bacteria. In some cases, an item may be treated with a specific biocide, such as pesticide, in order to repel insects. Various biocides are used to control the growth of or kill bacteria, microbial activity, insects, rodents or fungus.

The US Environmental Protection Agency (EPA) uses a slightly different definition for biocides than the EU. It defines a biocide as "a diverse group of poisonous substances including preservatives, insecticides, disinfectants, and pesticides used for the control of organisms that are harmful to human or animal health or that cause damage to natural or manufactured products". When compared, the two definitions roughly imply the same, although the US EPA definition includes plant protection products and some veterinary medicines.

In the US and Canada, regulatory agencies use the broad term pesticide to cover various toxic chemicals, instead of the term biocide. A pesticide is defined as any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, desiccant, or any nitrogen stabilizer. While the definitions differ slightly, the intent is the same.

In Canada, a pesticide is any product, device, organism, substance or thing that is manufactured, represented, sold or used as a means for directly or indirectly controlling, preventing, destroying, mitigating, attracting or repelling any pest.

Consumer goods can be manufactured with a variety of biocides. A biocide can be defined as an active chemical molecule to control the growth of or kill a specific organism. The regular use of personal hygiene products (e.g. cosmetics, wipes), cleaning products, laundry detergents, pet disinfectants and general disinfectants are the major sources of exposure to biocides in the home. Biocides can be classified into many different categories, such as:

● Disinfectants ● Preservatives ● Insecticides ● Fungicides ● Rodenticides ● Algicides

While this paper will concentrate on the treated products sold in the US, EU and Canada, it is worth noting that there are many other countries that have either their own biocide legislation or are in the process of implementing new laws. This includes countries such as Japan, South Korea and China.

As mentioned above biocides can be categorized into various categories or groups dependent on their function. The EU, US and Canada each have 4 main groupings that classify types of biocide. However, each country utilizes a different classification system.

In the EU the Biocidal Products Regulation (BPR) classifies biocides under the following 4 categories, disinfectants (5), preservatives (8), pest control (7), other (2) and 22 subcategories.

The US classifies biocides as conventional pesticides, antimicrobial pesticides, biopesticides (3), types of pesticides derived from certain natural materials, and inert ingredients.

Canada considers all biocides as pesticides and classifies them as domestic class, commercial class products, restricted products (can only be used under certain circumstances by specially trained individuals), pesticides or products regulated under the Feeds Act or Fertilizers Act.

For the purposes of this paper we are going to concentrate primarily on disinfectant and preservative biocides in consumer products, such as textiles and/or household domestic products, these function primarily as antimicrobial biocides.

The inclusion of a biocide in a domestic or commercial article in the United States, European Union or Canada may result in it being categorized as a “treated article” or “biocidal product”. The definitions and fine points will be discussed later in this paper.

3. Antimicrobials

Antimicrobial biocides have seen the most commercial growth in the last several years in the consumer products sector. These materials have been included in many home textiles and sporting good products in order to inhibit microbial growth and prevent odors or product degradation. Consumer products that have been treated to prevent microbial growth include:

● Building materials (wood, plastic, paints, adhesives, caulks, etc.) ● Cleaning products ● Computer peripherals (keyboards/mice) ● Consumer flooring ● Door hardware ● Food storage containers ● Home appliances (washer seals, refrigerator/freezer seals) ● Kitchenware ● Light switches ● Medical products (hospital gowns, patient clothes, curtains, bed covers, etc.) ● Paint ● Pet products ● Pool & spa products

● Soaps and lotions ● Sporting goods & exercise equipment ● Textiles ● Travel accessories

When we discuss various microbial activity it's important to understand that microbes are microscopic organisms that exist as unicellular, multicellular, or cell clusters. Microorganisms can be classified into six major types: bacteria, archaea, fungi, protozoa, algae and viruses. There is also a seventh classification, helminths (round/flat worms), which is not technically a microorganism but does live part of its lifecycle in a microscopic form.

Antimicrobial properties enhance the performance and lifespan of consumer products. In fabrics, the formation of unpleasant odors is reduced resulting in pleasant and fresh smell to the item even after use. Antimicrobial agents can be manufactured into a range of materials including plastics, coatings, textiles and many more. Kitchen fixtures stay cleaner for longer and prevent harmful microbial growth on surfaces.

4. Textiles

Through the exposure of textile products to microbial activity, fabric materials are subject to material degradation, non-removable staining and permanent odors. This can lead to products being discarded well ahead of their expected lifespan. The use of various antimicrobial chemicals can prevent this from occurring.

The use of natural antimicrobial agents on textiles goes back as far as ancient Egypt. The Egyptians began the science of textile preservation through the use of various spices and herbs to preserve mummy wrappings. The Chinese later used bamboo, containing an antimicrobial substance, bamboo-kun, in housing design and construction. In the 1940's military organizations used antimicrobials such as chlorinated waxes, copper and antimony salts to prevent textiles from rotting. Products such as tents, tarpaulins and truck covers needed to be protected from microbial degradation created by exposure to harsh weather conditions.

Today, antimicrobial textiles can be made of a variety of fabric materials, such as cotton/flax, polyester, polyester-vinyl composites, vinyl, and even acrylics. The effectiveness of an antimicrobial fabric lies in its ability to inhibit or mitigate the growth of various microorganisms, and to help prolong the lifespan of a textile product.

There are various types of antimicrobial agents, and compounds used have included: silver, quaternary ammonium compounds, triclosan, metal salts, or even natural polymers. Other regularly used biocides in the textile industry include organo-copper compounds, organo-tin compounds and chlorinated phenols.

Copper naphthenate and copper-8-hydroxyquinolinate are multipurpose biocides, specifically against fungi, bacteria, and algae. They are used to prevent deterioration of textiles i.e., cotton and flax canvases, awnings, tarpaulins, tents, outdoor sporting apparel and gear that are exposed to soil and/or extreme weathering conditions.

Silver is a noted bactericide and particularly effective against such bacterial organisms as Pseudomonas aeruginosa, S. aureus, Staphylococcus epidermidis, E. coli and Klebsiella pneumonia. Market data from European manufacturer surveys has shown that silver salts are one of the most common substances used in textiles.

A niche application is for outdoor clothing using various pesticide biocides. With the increased concern over mosquito borne diseases such as Zika and West Nile virus, as well as tick borne diseases like Rocky Mountain spotted fever and Lyme’s disease, more insect repellent clothing and outdoor gear is becoming available to consumers. Pesticide impregnated clothing is not considered a treated article but as a pesticide product itself, requiring registration.

Any antimicrobial or pesticide treatment performed on a textile must be non-toxic to the consumer and to the environment, as well as authorized under the country's biocide legislation.

5. Biocide Regulations

In the EU, biocides are regulated by the Biocidal Products Regulation (BPR) regulation (EU) No 528/2012, in the US under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and in Canada under their Pest Control Products Act (PCPA).

Agencies responsible for regulatory enforcement are the European Chemicals Agency (ECHA), US Environmental Protection Agency (EPA) and Health Canada’s Pest Management Regulatory Agency (PMRA).

6. European Union

The Biocidal Products Regulation (BPR) requires that all biocidal products be authorized by the ECHA before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved. However, the BPR exempts consumer products that have their own specific legislation (directives or regulations). There are 12 listed exemptions of various consumer products (toys, cosmetics, food, etc.).

For example, the use of antimicrobials as preservatives in cosmetics is regulated by the EU Directive 76/768/EEC (Cosmetics Directive). Fifty-seven chemicals listed in Annex VI of this Directive are permitted, with the restrictions laid down in the Annex, for the use as preservatives in cosmetic products. The function of these molecules in the cosmetics is the protection of the products from microbial degradation.

The basic principle in the BPR is that a biocidal product must be authorized before it can be made available on the market or used in the European Economic Area (EEA) and Switzerland. This takes place in two consecutive steps. First, the active substance is evaluated and, provided the criteria are fulfilled, is then approved in a specified product-type. The second step is the authorization of each product consisting of, containing or generating the approved active substance(s). The BPR regulates 22 different product type (PT) of biocides across 4 categories. The 4 categories are:

● Main Group 1: Disinfectants (5) ● Main Group 2: Preservatives (8) ● Main Group 3: Pest control (7) ● Main Group 4: Other biocidal products (2)

6.1. Approved Substances

In the EU a list of approved biocides is maintained by the ECHA. A biocidal product is not able to be placed on the EU market if the active substance supplier or product supplier is not listed in the active substance suppliers list, which is also called the Article 95 list. Biocidal substance authorizations are done on a case by case basis and cannot exceed 10 years but may be renewed.

According to the database on approved substances (Annex I of the BPR), as of 9/1/2020 there are:

● 884 active substances ● 4832 biocidal products ● 4682 manufactures

The BPR also regulates articles treated with, or intentionally incorporating, one or more biocidal products. Treated products and biocidal products are two different categories of goods. It is up to the Member States to decide whether a specific product is a treated article or a biocidal product.

There are different rules in the BPR for a biocidal product and for an article treated with biocides. In order to determine whether something is a biocidal product or article treated with biocides, you must be clear about whether the article has primarily a biocidal function or whether the biocidal function is one of several functions.

If the primary purpose of your article is to protect against, render harmless or deter harmful or irritating organisms (such as insects or bacteria), your article is then a biocidal product. A biocidal product must be authorized before it may be sold or used. For instance, an anti-bacterial wipe is a biocidal product – not a treated article – because its sole purpose is to control bacteria. Hand sanitizer is a biocidal product. This also applies to articles manufactured outside of the EU. Some treated articles may require additional labeling.

6.2. Treated Articles - Article 58

Under the BPR, Article 58, a ‘treated article’ is defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

Treated articles are divided into three categories depending on their reference to active substances and their biocidal properties:

● Treated articles with no claim or reference to biocidal properties, for example, paint or ink. Biocidal products are a necessary part of the formula of practically all water-based inks and varnishes, as well as of many water-based fountains solutions and cleaning agents for offset printing in order to prevent microbiological growth and contamination. Liquid ink is not a “biocidal product” but a “treated article”. After the printing process the dried ink layer will not show biocidal effects. Consequently, the final printed material would not be a “treated article” as it is not treated itself with a biocidal product and does not intentionally incorporate a biocidal product, as far as the printing ink is concerned.

● Treated articles with a claim referring to biocidal properties, for example, textiles treated with silver for antibacterial purposes. A t-shirt which is treated with a biocidal product to protect the product from bacterial attack is considered an article treated with biocides. It need not be authorized before being sold, but it may only be treated with an authorized active substance that is allowed in the EU. The person selling an article treated with biocides must provide information about which biocidal product it contains and must make sure that the article has the correct labeling.

● Treated articles with no reference to biocidal properties but with approved active substances and related labeling requirements. Examples include wooden articles treated with a wood preservative (pressure treated lumber), or a textile mosquito net treated with a textile preservative. According to BPR, such products would be considered treated articles, but not biocidal products.

In each of these three cases, the active substance must have been approved or be under review.

6.3. Labeling

If you make biocidal claims for the article, it may have to carry a label with information about the biocide that was used. The BPR requires manufacturers and importers of treated articles to label the treated articles when:

● A claim that the treated article has biocidal properties is made ● It is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article

Manufacturers and importers of treated articles have to make sure that products are correctly labeled. The label should be easy to read, visible and in the national language of the Member State of introduction.

When a treated article is placed on the market and it refers to the biocidal properties of the active substances within it, the label also has to contain:

● A statement that the treated article incorporates biocidal products ● The biocidal property attributed to the treated article ● The names of the active substances ● If present, the names of each biocidal (nano) substance followed by the word ‘nano’ in brackets ● Any relevant instructions for use

Note: Regulations have binding legal force throughout every Member State and enter into force on a set date in all the Member States. Directives lay down certain results that must be achieved but each Member State is free to decide how to transpose directives into national laws.

7. United States

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the registration of any substance intended to prevent, destroy, repel, or mitigate pests. The EPA classifies and registers pesticides into 4 categories. The categories that are important for the registration process are:

1. Conventional pesticides

This includes all ingredients other than biological pesticides and antimicrobial pesticides.

2. Antimicrobial pesticides

Defined as substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects and surfaces.

“Antimicrobial pesticide” is defined in section 2(mm) of FIFRA as a pesticide that is intended to:

● Disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and is exempt from or not subject to a tolerance or a food additive regulation

The following products are also antimicrobial pesticides:

● Any other chemical sterilant products (other than liquid chemical sterilant products exempted under FIFRA section 2(u)) ● Any other disinfectant products ● Any other industrial microbiocide products ● Any other preservative products that are not excluded below

The following products are NOT antimicrobial pesticides:

● Wood preservative or antifouling paint products for which a claim of pesticidal activity other than or in addition to antimicrobial activity is made (in other words, wood preservative and antifoulant paint products that only have claims pertaining to microorganisms are antimicrobial pesticides, but the presence of additional claims such as insecticidal claims make the product a non-antimicrobial pesticide) ● Agricultural fungicide products ● Aquatic herbicide products

Antimicrobial products contain about 275 different active ingredients and are marketed in many types of formulations including: sprays, liquids, concentrated powders and gases. More than 4000 antimicrobial products are currently registered with EPA and sold in the marketplace.

The EPA has broken antimicrobials into 12 usage categories:

● Agricultural premises and equipment ● Food handling/storage establishments, premises, and equipment ● Commercial, institutional and industrial premises, and equipment ● Residential and public access premises ● Medical premises and equipment ● Human drinking water systems ● Materials preservatives ● Industrial processes and water systems ● Antifouling coatings ● Wood preservatives ● Swimming pools ● Aquatic areas

3. Biopesticides

Biopesticides are a type of pesticide derived from such natural materials as animals, plants, bacteria and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. Biopesticides fall into three major classes:

● Microbial pesticides ● Plant-incorporated protectants ● Biochemical pesticides

4. Inert ingredients

Substances contained in pesticides in addition to the active ingredient(s).

7.1. Approved Substances

FIFRA currently lists 2905 substances in their chemical search database, 808 of which are classified as antimicrobials. EPA is reviewing each registered pesticide every 15 years to determine whether it still meets the FIFRA standard for registration.

While the EPA has responsibility for registration of pesticide substances, there is crossover jurisdiction with the FDA for compounds used in food, drugs and cosmetic products, as well as medical devices. The responsibilities of each agency have been clarified in various Memorandums of Understanding (MOU’s) between the two agencies. An example is:

In 2016 the FDA banned the following antimicrobial chemicals in soaps and lotions because of health concerns:

● Cloflucarban ● Fluorosalan ● Hexachlorophene ● Hexylresorcinol ● Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) ● Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) ● Nonylphenoxypoly (ethyleneoxy) ethanoliodine ● Poloxamer-iodine complex ● Povidone-iodine (5 to 10 percent) ● Undecoylium chloride iodine complex ● Methylbenzethonium chloride ● Phenol (greater than 1.5 percent) ● Phenol (less than 1.5 percent) 16 ● Secondary amyltricresols ● Sodium oxychlorosene ● Tribromsalan ● Triclocarban ● Triclosan ● Triple dye

7.2. Treated Articles

FIFRA requires registration of any substance intended to prevent, destroy, repel or mitigate pests. But articles or products that are treated with registered antimicrobial pesticides are not

12 subject to registration requirements if the antimicrobial pesticides are used to protect the articles or products themselves. Thus, the EPA will only exempt a treated article from the Act’s requirements if the treating pesticide is already registered. The Code of Federal Regulations (40 CFR 152.25(a)) contains the requirements under which an exemption from registration is allowed for treated articles or substances. The EPA grants the treated articles exemption for a non-public-health use of a pesticide that is intended to protect only the treated article or substance itself.

The term "treated articles" is defined as items that are treated with an antimicrobial pesticide to protect the item itself. The pesticides are usually added to the products (e.g., plastic shower curtain) during manufacture, however, they may be added after manufacture but before use of the article (e.g., incorporation of a pesticide in paint).

These treated products often claim to protect the public against harmful microorganisms. These fall into a regulatory category of implied or explicit public health pesticidal claims.

Known as the "Treated Articles Exemption," section 152.25(a) provides an exemption from all requirements of FIFRA for qualifying articles or substances treated with, or containing a pesticide, if:

1. The incorporated pesticide is registered for use in or on the article or substance 2. The sole purpose of the treatment is to protect the article or substance itself

To qualify for the treated articles exemption, both conditions stated above must be met. If both are not met, the article or substance does not qualify for the exemption and is subject to regulation under FIFRA.

7.3. Labeling

Under FIFRA a pesticide product must be labeled as follows:

All registered pesticide products must display labels that show the following information clearly and prominently:

● Name, brand or trademark product sold under ● Name and address of the producer or registrant ● Net contents ● Product registration number ● Producing establishment’s number

● Ingredient statement ● Warning or precautionary statements ● Directions for use ● Use classification

Consumers may distinguish treated articles by the absence of the EPA's pesticide registration number of the registered pesticide used for protecting the article itself.

A product that incorporates an antimicrobial pesticide, but does not make claims about antimicrobial effect, is not regulated under FIFRA, but is instead subject to reporting requirements under the Toxic Substances Control Act (TSCA).

A product whose label includes public health claims, such as "prevents bacterial growth", is required to satisfy the Act’s requirements and must display an EPA-approved product label. However, the status of specific claims under FIFRA is not always clear, and it is important to undertake a careful analysis to determine which requirements apply.

A product that does make a claim about antimicrobial effects – such as "contains a preservative" – on the product itself, falls under FIFRA’s treated articles exemption. To meet the treated articles exemption labeling requirements, the product label may only bear claims that the product itself is protected by the pesticide. For example, a claim must make clear that the article has been treated with the antimicrobial product to protect the product from the growth of microbes. Product labeling that does not clearly meet this requirement, is likely not acceptable under the Treated Articles Exemption because it expresses or implies protection that extends beyond the article itself.

8. Canada

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for administering the Pest Control Products Act which requires that all pest control products be assessed as to their safety, merit and value. The intent of the legislation is to ensure the acceptability of the risks, safety, merit and value of pest control products used in Canada. Canada’s regulatory system allows for federal, provincial and municipal regulations.

Pesticides include:

● Herbicides, which are used against weeds ● Insecticides, which are used against bugs

● Fungicides and antimicrobial agents, which are used against fungus and other microorganisms ● Material and wood preservatives ● Animal and insect repellents ● Insect and rodent controlling devices, such as mosquito zappers and mouse traps ● Algicides, which can be used to control algae in pools and spas

Pesticides have been classified into 4 main groups:

● Domestic class - products are for personal use in and around the home ● Commercial class - products that are restricted to commercial activities as indicated on the label. These are not available to the general public for use in and around the home ● Restricted products - can only be used under certain circumstances by specially trained individuals. These are not available to the general public ● Pesticides or products regulated under the Feeds Act or Fertilizers Act

8.1. Approved Substances

The total number of active ingredients registered for use in Canada has increased from approximately 560 in 2007 to 658 towards the end of 2018. The overall number of registered products increased from approximately 5505 to 7707 between 2007 and March 2019, despite the removal of many older products. 884 of the products are designated as Material Preservatives.

Of those 658 active ingredients 51 are designated as antimicrobial. As of 30 August 2020 the PMRA has 5236 registered antimicrobial products utilizing 51 antimicrobial active ingredients that manufacturers can consider using when treating an article.

Pesticides are required to be reviewed every 15 years in order to maintain their legality. As new information becomes available any pesticide may be removed from the list.

8.2. Treated Articles

Treated articles are defined as a pest control product under the Pest Control Products Act. The antimicrobial preservative used to treat the article is always required to be registered under the Pest Control Products Act; however, the PMRA will not require the registration of some articles treated with an antimicrobial preservative, if they meet certain criteria. Even though some

15 articles may be exempt from registration (including documentation and renewals), they are still subject to regulatory oversight.

Treated articles that require registration

If a pesticide has been incorporated into or applied to an article in order for the article to act as a delivery mechanism for the pesticide, the pesticide (for example, insecticide) and the treated article (for example, clothing) must each be registered as a pest control product under the Pest Control Products Act. In this example, the clothing acts as a delivery mechanism for the pesticide when it is treated with an insecticide to repel mosquitoes or ticks.

Treated articles that require registration of the pesticide only

If a pesticide has been incorporated into or applied to an article in order to provide a benefit to the product itself (in other words, preservation) the pesticide (in other words, the antimicrobial preservative) must be registered under the Pest Control Products Act for that specific use. In this case, the PMRA will not typically require the registration of the treated article itself.

Thus, for articles treated with antimicrobial preservatives, the PMRA will generally exempt the article itself from registration, as long as the following conditions are met:

● The antimicrobial preservative used to treat the article is registered under the Pest Control Products ● The article is treated according to the antimicrobial preservative’s approved uses (in other words, the same use specified on the label of the registered end-use product); and the use is limited to preventing degradation or damage to the product from microorganisms

8.3. Labeling

Pesticides labels are required to carry the following information:

● Trade or product name ● Classification ● Pesticide type ● Active ingredient(s) and guarantee of concentration ● Type of formulation ● Pest control product registration number ● Registrant's name and address

● Net contents of package ● Directions for use ● Degree and nature of hazards ● Precautionary statements and handling precautions ● First aid instructions ● Toxicological information ● Notice to user

An antimicrobial treated article must be labeled with clear and easily understandable information for the consumer. This applies to all articles which are:

● Sold with a claim that the article has a specific function ● Treated with an active substance that requires labeling according to the approval of the substance. The treated article should also be labeled with relevant instructions for use, including precautions, if this is necessary to protect humans, animals, and the environment

Claims on articles treated with an antimicrobial preservative are limited to the effect of the antimicrobial preservative used to treat the articles. As per section 6 of the Pest Control Products Act, any misleading marketing claims that do not accurately reflect the purpose of the antimicrobial treatment are not permitted.

Claims such as "antimicrobial" and "preservative" cannot be used alone and must be properly qualified. A properly qualified claim would be similar to the following:

"Treated with an antimicrobial that provides mildew-resistant dried paint coating".

9. Comparison of EU / US / Canada Legislation

The below table has been assembled to provide an overview of some different country legislation requirements.

European Union United States Canada

Biocide A biocide is defined in the The EPA defines a biocide Health Canada defines European legislation (BPR) as as "a diverse group of pesticide as any product, a chemical substance or poisonous substances device, organism, substance microorganism intended to including preservatives, or thing that is manufactured, destroy, deter, render insecticides, disinfectants, represented, sold or used as harmless, or exert a and pesticides used for the a means for directly or controlling effect on any control of organisms that indirectly controlling, harmful organism. are harmful to human or preventing, destroying, animal health or that cause mitigating, attracting or damage to natural or repelling any pest. manufactured products".

Treated article The term ‘treated article’ The term ‘treated article’ Treated articles are defined means any substance, mixture typically refers to items as a pest control product or article which has been that are treated with an under the Pest Control treated with, or intentionally antimicrobial pesticide to Products Act. incorporates, one or more protect the item itself. biocidal products.

Classifications ● Disinfectants ● Conventional ● Domestic class ● Preservatives ● Antimicrobial ● Commercial class ● Pest control ● Biopesticides ● Restricted products ● Other biocidal ● Inert ingredients ● Manufacturing - products Pesticides or products regulated under the Feeds Act or Fertilizers Act

Regulated Articles that have been treated Articles or products that Treated articles are defined product with a biocide do not need are treated with registered as a pest control product authorization, but they can antimicrobial pesticides are under the Pest Control only be placed on the EU not subject to registration Products Act. The market when the active requirements if the antimicrobial preservative substance in the biocide has antimicrobial pesticides are used to treat the article is been approved for the specific used to protect the articles always required to be use. or products themselves. registered under the Pest Control Products Act; however, the PMRA will not require the registration of some articles treated with an

antimicrobial preservative, if they meet certain criteria

Approved active 884 2905 658 substances

Chemical review Chemicals are approved on a 15 years 15 years period case by case basis but cannot exceed 10 years.

9.1. Similarities and Differences

Unlike the more stringent safety threshold required by the EU, the pesticide industry in the US has only to demonstrate that its products “will not generally cause unreasonable adverse effects on the environment,” which is partially defined as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide”.

While the EU and Canada both follow the “precautionary principle”, Canada has often reached different conclusions on the hazards of certain pesticides. The EU prohibits the use of a number of active substances in pesticides that are authorized in Canada.

For imported treated articles, all three jurisdictions require that the active ingredient used be registered in their jurisdiction for such use. The majority of antimicrobial preservatives used in manufacturing are currently registered in all three jurisdictions. Each country also has restrictions around label claims (for example, claims cannot be misleading).

The US and Canada include agricultural pesticides under their main legislation. The EU BPR only addresses non-agricultural biocide/pesticide products.

Some silver compounds have recently run into registration / authorization issues in the EU and Canada. For instance, the PMRA has stated that nano-silver is not an approved pesticide. ECHA evaluations were also undertaken for applications for use of silver copper zeolite, silver sodium hydrogen zirconium phosphate, and silver zeolite. The applications were for use of the substances in certain product types: disinfectants and algaecides not intended for direct application to humans or animals (type 2) and film preservatives (type 7). ECHA’s Biocidal Products Committee concluded in October 2018 that these substances should not be approved for use in these product types.

Some countries have regulations that have multiple jurisdictions between agencies, i.e., FDA and EPA in the US, while the EU BPR legislation specifically exempts products covered under separate directives or regulations. In Canada, the federal departments of Agriculture Canada, Environment Canada, and Health and Welfare Canada coordinate the regulation of pesticides. In Canada, pesticide regulation is also under the shared authority of the federal, provincial, territorial governments as well as municipal entities.

The US and Canada require pesticides be reviewed every 15 years, the EU at least every 10 years. These schedules are all subject to change based on new scientific understanding and information.

10. Companies

By 2024 antimicrobial’s ingredient usage and sales is expected to increase from 5 to 7 billion dollars/year. A large amount of growth is expected in the cosmetics and personal care products in the preservative applications sector and especially in South America.

● The Dow Chemical Company ● Lonza Group Ltd ● BASF SE ● Croda International Plc ● Clariant AG ● Biocote ● Verital ● Microban ● Kemin ● Akzo Novel N.V. ● Evonik Industries A.G.

Some of the commercial compound available include:

● Irgaguard 1000 - BASF (Ciba) Finishing agent - based on triclosan ● Irgasan - Sigma Aldrich Finishing agent - based on triclosan ● Microban International Agent - based on triclosan ● Silvadur - The Dow Chemical Company - Interpenetrating polymer network with silver ions ● Saniguard Nano-ZN L.N. Chemical Industries Finishing solution based on an aqueous nano-dispersion of zinc oxide

Note: triclosan is an organic compound known as a diphenyl ether, currently banned in soaps and hand sanitizers by the US FDA.

11. Conclusion

In summation, biocide legislation is becoming more and more prevalent in the world marketplace. Biocides encompass a wide variety of compounds such as herbicides, insecticides, fungicides, antimicrobial agents and algicides. Biocides legislation has been enacted for a variety of products such as agricultural, food, cosmetic and medical, as well as consumer products. In most cases biocides may be regulated by several different regulatory agencies depending on the intended product use.

Antimicrobial and antifungal types of pesticides are seeing much use in everyday consumer products. These products are defined in the EU, US and Canada as “treated articles”. For treated articles it is important to remember that whatever pesticide / antimicrobial agent you may be using it must be registered / authorized in each country of use. In certain cases, as with pesticide repellent it may be necessary to register the product as well as the pesticide.

Additionally, each country has specific labeling requirements. In some cases, registration #’s may be required, as well as listing the active substance used on the product label. Products should be addressed on a case by case basis.

Finally, biocide legislation is becoming more prevalent across the world. Major markets like Brazil, Russia, India and China have enacted or are in the process of passing their own biocide legislation.

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12. Sources

1. “Antibacterial vs Antimicrobial, Definitions & Explanations.” Microban, www.microban.com/antimicrobial-solutions/overview/antibacterial-vs-antimicrobial

2. “Antimicrobial Consumer Product Protection.” Microban, www.microban.com/antimicrobial-solutions/environments/consumer

3. BIOSAFE® Antimicrobial Technology. 18 Sept. 2020, www.gelest.com/applications/antimicrobial_materials/

4. “Biocides in Textile.” Fibre2Fashion, www.fibre2fashion.com/industry-article/27/biocides-in-textile

5. Boundless. “Boundless Microbiology.” Lumen, https://courses.lumenlearning.com/boundless-microbiology/chapter/microbes-and-the- world/

6. Davis, Rachael. “Rachael Davis.” Textile World, 22 Feb. 2017, www.textileworld.com/textile-world/features/2017/02/antimicrobial-fibers-history-uses- applications/

7. Erica Hartmann Assistant Professor. “Many Household Products Contain Antimicrobial Chemicals Banned from Soaps by the FDA.” The Conversation, 11 July 2018, https://theconversation.com/many-household-products-contain-antimicrobial-chemicals -banned-from-soaps-by-the-fda-70977

8. Markets, Research and. “$7+ Billion Antimicrobial Ingredients Market - Global Forecasts from 2019 to 2024: Increasing Use of Antimicrobial Agents in Cosmetic and Personal Care Products.” PR Newswire: News Distribution, Targeting and Monitoring, 13 Sept. 2019, www.prnewswire.com/news-releases/7-billion-antimicrobial-ingredients-market---global- forecasts-from-2019-to-2024-increasing-use-of-antimicrobial-agents-in-cosmetic-and-per sonal-care-products-300917930.html

9. Morais, Diana Santos, et al. “Antimicrobial Approaches for Textiles: From Research to Market.” Materials (Basel, Switzerland), MDPI, 21 June 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC5456784/

Canada

1. Branch, Legislative Services. “Consolidated Federal Laws of Canada, Pest Control Products Act.” Pest Control Products Act, 17 Sept. 2020, www.laws-lois.justice.gc.ca/eng/acts/P-9.01/

2. Branch, Legislative Services. “Consolidated Federal Laws of Canada, Pest Control Products Regulations.” Pest Control Products Regulations, 17 Sept. 2020, https://laws-lois.justice.gc.ca/eng/regulations/SOR-2006-124/index.html

3. Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 18 Dec. 2018, www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publicatio ns/pesticides-pest-management/fact-sheets-other-resources/treated-articles.html

4. Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 24 Jan. 2020, www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publicatio ns/pesticides-pest-management/corporate-plans-reports/annual-report-2018-2019.html

5. Dell Tech Follow. “Treated Articles - Canada.” SlideShare, 8 Apr. 2019, www.slideshare.net/DellTechLab/treated-articles-canada-140036868

6. “Pesticide Product Information Database.” Health Canada, https://pesticide-registry.canada.ca/en/disclaimer-page.html

7. CETA Threatens EU and Member States’ Ability to Effectively Regulate the Dangers of Pesticides, 5 July 2017, www.ciel.org/wp-content/uploads/2017/07/CIEL_CETA-Pesticide-Report_6july2017.pdf

European Union

1. Elges, Jessica. “The Good, the Bad and the Regulatory: Biocidal Products Regulation.” BioCote, BioCote, 7 Mar. 2017, www.biocote.com/blog/biocidal-products-regulation-

2. EU Biocidal Products Regulation, Eur-Lex.europa.eu.

3. “Information on Biocides.” ECHA, https://echa.europa.eu/fr/information-on-chemicals/biocidal-products

4. “Treated Articles.” ECHA, https://echa.europa.eu/fr/regulations/biocidal-products-regulation/treated-articles

5. What You Need to Know about Treated Articles , ECHA, https://echa.europa.eu/documents/10162/26065889/treated_articles_inbrief_en.pdf

United States

1. “BERGESON & CAMPBELL PC.” FAQ - FIFRA | Knowledge & Resources, www.lawbc.com/knowledge-resources/faq-fifra/

2. Commissioner, Office of the. “FDA Issues Final Rule on Safety and Effectiveness of Consumer Hand Sanitizers.” U.S. Food and Drug Administration, FDA, www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effect iveness-consumer-hand-sanitizers

3. Commissioner, Office of the. “FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps.” U.S. Food and Drug Administration, FDA, www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effect iveness-antibacterial-soaps

4. “Consumer Products Treated with Pesticides.” EPA, Environmental Protection Agency, 18 May 2020, www.epa.gov/safepestcontrol/consumer-products-treated-pesticides

5. “Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Facilities.” EPA, Environmental Protection Agency, 27 Jan. 2020, www.epa.gov/enforcement/federal-insecticide-fungicide-and-rodenticide-act-fifra-and-fe deral-facilities

6. “Pesticide Chemical Search.” EPA, Environmental Protection Agency

7. “Pesticide Registration Manual.” EPA, Environmental Protection Agency, 20 Apr. 2017, www.epa.gov/pesticide-registration/pesticide-registration-manual

8. “ Subchapter E - PESTICIDE PROGRAMS (Parts 150 - 180).” Govinfo, www.govinfo.gov/app/collection/cfr/2019/title40/chapterI/subchapterE/part150

About the Author

Jerry Miller Senior Regulatory Consultant, Compliance & Risks

Jerry is a Senior Regulatory Consultant with 20 years experience in regulatory and standards interpretation, spanning the fields of consumer products and environmental investigation.

At Compliance & Risks, Jerry performs international research and database creation for clients and acts as a subject matter expert on various laws and standards.

About Compliance & Risks

Compliance & Risks helps manufacturers, retailers and their supply chain partners monitor and manage requirements, regulations and standards for a cleaner, safer and better world. It creates business advantage for clients by providing reliable legislative information, insights and actions through C2P, its compliance knowledge management platform, consulting, market access, managed services and other solutions.

The company is recognized as the end to end global regulatory solutions provider across the technology, consumer goods and retail, industrial goods and life sciences sectors. Headquartered in Cork, they also have offices in Brussels, California, London and New York. For more information, please visit www.complianceandrisks.com

Important Notice: All information provided by Compliance & Risks Limited and its contributing researchers in this report is provided for strategic and informational purposes only and should not be construed as company specific legal compliance advice or counsel. Compliance & Risks Limited makes no representation whatsoever about the suitability of the information and services contained herein for resolving any question of law. Compliance & Risks Limited does not provide any legal services. © 2020 Compliance & Risks Limited. All rights reserved