Compounding World: July 2015

Manufacturers that want to use antimicrobials in medical applications must obtain the appropriate regulatory clearances. In the US, antimicrobials intended to control microorganisms on or in people or animals (e.g. on medical devices with this intent) fall under the jurisdiction of the Food and Drug Administration (FDA), while  any other antimicrobial use falls under the Environmental Protection Agency (EPA's) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Claims made for devices under FDA must be cleared by the 510(k) premarket notification process.

In Europe antimicrobial medical devices must be cleared by a Notified Body and frequently require a consultation with an EU Competent Authority says Moloney from Sciessent. In March 2015, Sciessent launched the Medical Device Market Acceleration Program (Med-MAP), which is designed to help manufactures efficiently move antimicrobial-treated products from concept and development to regulatory approval and commercialization in the US, Europe, Asia and Latin America. For example, Sciessent worked with a company to obtain Class 1 CE Mark Approval for an antimicrobial-treated, disposable, hygienic barrier that attaches to a blood-pressure cuff to prevent hospital-acquired infections. Sciessent recently put an Active Substance Master File on file with a Competent Authority in Europe as a resource for medical-device manufacturers looking for Class 111 CE Mark Approval.


RAS materials expects to receive EU approval for its nanosilver called Agpure. RAS says Safety studies were conducted by the Organisation for Economic Co-Operation and Developments (OECD's) Working Party on Manufactured Nanomaterials (WPMN), which uses Agpure as a reference material, notes Gregor Schneider from RAS. The company expects to receive EU approval under the Biocidal Products Regulation based on the OCED WPMN test results.

In the US, the same regulatory rules apply to nanosilver as any other biocide. "EPA's policy regarding nano-pesticides and inerts, albeit proposed, is clear: EPA applies an initial presumption that nanoscale versions of previously-registered active or inert ingredients in pesticide products are considered new ingredients subject to Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) registration," explains Lynn Bergeson, managing  partner at Bergeson & Campbell, a Washington, DC law firm. "EPA also currently takes the position that each unregistered source of nanosilver is a new active ingredient  and different than other currently registered  sources of nanosilver. EPA  has stated that, over time, it may develop the experience and establish a record that would allow EPA to conclude that different sources of nanosilver with the same particle size and charge are the same active ingredient".

EPA had previously issue one FIFRA registration for nanosilver to HeiQ for an antimicrobial fabric treatment, and this May issued a registration for an nanosilver - containing antimicrobial  pesticide  product named NSPW-L30SS to Nanosilva.  According to an EPA announcement, "This silver–based product will be used as a non–food-contact preservative to protect plastics and textiles from odour and stain-causing bacteria, fungi, mould and mildew. Items to be treated include, for example, household items, electronics, sports gear, hospital equipment, bathroom fixtures and accessories."

After evaluating the available data, EPA said "these data show that plastic and textiles treated with NSPW-L30SS release exceedingly small amounts of silver. Based on this evaluation, the Agency determined that NSPW-L30SS will not cause unreasonable adverse effects on people or the environment  than competing products and would be beneficial because it will introduce less silver than competing products. EPA is also requiring the Company to generate additional data to refine the Agency's exposure estimates."

In the US , Companies that wish to use or market nanosilver in plastics should seek advice from EPA's Office  of Pesticide Programs (OPP) or seek legal counsel, advises Bergeson. "Marketers of such products are subject to intense scrutiny. Federal regulators are interested in compliance with FIFRA, state regulators are interested in compliance with state pesticide requirements, including state Attorneys General for compliance with state consumer protection laws, and citizen groups are interested in ensuring products marketed to consumers are legally compliant, registered as required, and safe when used as intended. Compliance with federal and state law is the best defence against potential tort actions that product manufacturers must also be careful to avoid."


 HSE: August 2015

The 1 September 2015 deadline in Article 95 of the EU Biocides Regulation (EU BPR) is fast approaching and biocidal products cannot be made available on the EU market after the September deadline unless either the substance supplier or the product supplier is included in the Article 95 list, published by the European Chemicals Agency (ECHA), for the product type to which the product belongs.

EXAMPLE: Biocidal products approved in the UK under the Control of Pesticides Regulations (COPR)

If your biocidal product has approval in the UK under the Control of Pesticides Regulations (COPR) you must demonstrate to HSE by 1 September 2015 that you or your supplier ARE included in the Article 95 list.

If HSE DOES NOT receive your evidence by 1 September 2015, the product's COPR approval will be restricted. This means from 1 September 2015 the biocidal products cannot advertised, sold and supplied on the UK market.

Use of biocidal products affected by the 1 September 2015 deadline

Article 95 (as amended) of the EU BPR does not prohibit use of stocks of products that have already been supplied before 1 September 2015. 

Therefore, after 1 September 2015 use of biocidal products affected by the 1 September 2015 deadline can continue until an approval decision (positive or negative) is taken for active substance(s) in the product, at which point the relevant phase out periods in  Article 89(2), 3(b) and 4(b) of EU BPR (as amended) will apply. If the biocidal product has approval under COPR the conditions of approval relating to storage and use continue to apply during this time and until the end of the Article 89 phase out period.


 Chemwatch: August 2015

The European Commission will adopt an implementing decision to clarify that tissue impregnated with citric acid is a biocidal product, it has notified the World Trade Organization (WTO). Comments on the proposal can be submitted until 13 September. The Commission aims to adopt the decision in October.



Asia Pacific Coatings Journal: August 2015

Wood has an arch-enemy in Water. Not only do rain and moisture spoil its appearance but they also promote blue stain fungus, mould and insect attach – which can lead to irreparable damage.

Anybody who uses wood outdoors should protect with a suitable treatment. Chemical wood preservatives can be roughly divided into two classes: impregnating agents and film-forming coatings. The former contain water repellent components, such as waxes, resins and oils and sometimes fungicides and insecticides. They penetrate into the wood, where they protect it from the inside out, due to their impregnating effect. Film-forming coatings work differently. They dry to form an intact water-repellent protective film. These types of system contain binders and preservatives, frequently along with biocides to protect against insect attack and mould. UV absorbing pigments can be added to ensure that the wood does not turn grey in direct sunlight. Typical film forming coatings include wood stains, paints and varnishes.

According to a PRA Irfab study, the coatings & varnishes market will grow between 1.4 and 2 percent until 2017. In 2012, some 1.2 Mt of wood coatings worth more than € 5bn were sold in Europe. The bulk of this was outdoor coatings, nine out of 10 treatments are either protective wood coatings, stains or impregnations. This group is dominated by solvent borne alkyd formulations which have about 80 % of the market.



Wood Floor Coatings

11 %

Exterior Wood Coatings

40 %

Trims, Paints and Varnishes

49 %



Going forward, VOC directives will mean the substitution of solvent based resins by water based resins such as silicone resins.


 Water Tech News: August 2015

Demand for water treatment chemicals in the US is forecast to rise 3.2 percent per year to $7.3 billion in 2019, representing 15.6 billion pounds. Rising demand will be supported by the increase in water recycling and reuse, both processes that typically needs more aggressive chemical treatment than fresh supply water or wastewater being treated for disposal. Increasing reliance on membranes and other types of water treatment equipment that work best when the water has been pretreated with chemicals will also support demand. Additionally, tighter standards for process water and waste-water quality, and concerns about the environmental impact of certain chemicals, will continue to favor more expensive specialty chemicals that can be used in lower doses and are less hazardous.

Changing disinfectant regulations to slow biocide demand

The increased adoption of water treatment equipment has also impacted the market for water treatment chemicals. While growth in biocide demand will be limited by the increased use of disinfection equipment, demand for other water treatment chemicals such as corrosion and scale inhibitors, foam control agents, and chelating agents will be supported by the increased use of equipment that requires pretreatment of the water with chemicals in order to maintain efficiency and prevent damage. The growing use of membranes, in particular, will support demand for coagulants and flocculants.

While demand for most water treatment chemicals is expected to rise at a healthy pace, growth in biocide sales will continue to be much slower. In addition to the negative impact of the rising use of disinfection equipment, biocide demand growth will be restrained by changing regulations and public opinion. In the municipal market, disinfection byproduct regulations have led to a decline in biocide use, although some biocides will continue to be necessary to meet residual disinfection requirements. In other markets, rising standards for process water will also restrain biocide demand, since biocides can be considered contaminants.

Municipal, manufacturing markets to remain largest

Among the major markets for water treatment chemicals, the municipal and manufacturing markets will continue to represent the bulk of demand. The mature municipal market will exhibit steady gains going forward, on pace with the increases seen over the previous decade, as municipal water use trends tend to be stable and slow to change. Additionally, water treatment operators are more price sensitive and often slow to adopt new technologies unless prompted to do so by changing regulations.

The energy, mining and mineral processing markets are also forecast to post strong gains going forward, supported by industry efforts to reuse water, as well as tighter restrictions on treated wastewater in some states. Demand for water treatment chemicals in commercial and institutional, consumer, and other markets will rise at a more limited pace, though gains in the consumer market will represent an improvement over previous years.