HAPPI: July 2017

US Patent No. 9,687,429 B2; The Trustees of Columbia University in the City of New York have patented a hand soap, hand sanitizer or hand cream composition that achieves more than about 4 Log10 reduction from control bacterial counts within 30 seconds of contact. It is comprised of lemongrass oil; orange oil; grapefruit seed extract; citric acid; a combination of octanediol and 1,3 propanediol; one or more additional ingredients selected from the group consisting of cationic surfactants, nonionic surfactants, amphoteric surfactants, cellulose polymers, cetearyl Alcohol, behentrimonium methosulfate, stearyl alcohol, glycerin, almond oil, jojoba oil, avocado oil, silicone polymers, silicone oil and combinations thereof; and an alcohol selected from the group consisting of: ethanol, isopropanol, phenoxyethanol and combinations thereof.


Press Release: July 2017

Hydrogen peroxide is used as active substance in the formulation of biocidal products and for the production of the active substance peracetic acid. Biocidal products containing hydrogen peroxide are applied in a variety of applications, e.g. as a disinfectant in water treatment, in the food and beverage industry, animal hygiene and also in the area of healthcare. Hydrogen peroxide has outstanding disinfectant properties and, as a potent antimicrobial agent, is effective against bacteria, molds and viruses, even at low concentration.

In the European Union biocidal products are subject to the Biocidal Products Regulation (BPR) (EU) Nr. 528/2012, which regulates the making available on the market and use of biocidal products in the European Union and shall harmonise the European rules for biocidal products and their active substances. The aim is to provide a high level of protection for people, animals and the environment and to ensure that products are sufficiently effective against the target organisms. The BPR stipulates a two-step process, in which the active substance evaluation is followed by a product authorisation of individual biocidal products.

With effect from February 1st, 2017, all biocidal products containing the active substance hydrogen peroxide, that are placed on the market and being supported as biocidal products under the BPR, have to be formulated with a technically equivalent active substance.

Furthermore, as of October 1st, 2017, any peracetic acid based active substances have to be produced with a technically equivalent source of hydrogen peroxide as defined in the active substance dossier for hydrogen peroxide.

To meet the demands of this regulatory requirement, Evonik has introduced the new product line HYPROX AS besides the existing product line PERSYNT LC. The active substances HYPROX AS and PERSYNT LC are both approved reference sources as defined under the Biocidal Products Regulation 528/2012.

This portfolio enhancement supports Evonik’s strategic focus as a provider of sustainable and environmentally benign solutions. Evonik is dedicated to provide the best products and services to its customers in order to support them in fulfilling the BPR requirements.


Chemical Watch: July 2017

The Echa's Biocidal Products Committee (BPC) has for the first time supported the approval of substances that meet the biocidal products Regulation's (BPR) exclusion criteria.

It adopted opinions on two formaldehyde releasers namely:

reaction products of para-formaldehyde and 2-hydroxy-propylamine (ratio 3:2) (MBO) for product-types two, six, 11, 12 and 13; and

reaction products of para-formaldehyde and 2-hydroxy-propylamine (ratio 1:1) (HPT) for product-types two, six, 11 and 13.

Public consultations on the two substances, held earlier this year, gathered too little information to conclude that there are suitable alternatives to their use, said BPC chair, Erik van de Plassche. They are commonly used for the disinfection of inner surfaces in metal working systems, as well as for the preservation of fuels, liquid cooling systems and metal working fluids.

The European Commission will launch another consultation to decide whether MBO and HPT meet one of the conditions under the BPR's Article 5.2. This allows candidates for exclusion to be approved if their risk is negligible, their use essential to control a serious danger, or if not approving them would have a disproportionate impact on society.

The BPC also supported the approval of MBIT for use in product-type six, a new active substance used to protect against a variety of bacteria and fungi that occur in-can in paints, detergents, and other products. Two further actives – imiprothrin and cypermethrin – were supported for use in product-type 18.

The adoption of an opinion on cholecalciferol in product-type 14 was delayed because the BPC concluded that it is a candidate for substitution. Echa is due to launch a public consultation on the substance soon. Following this, the opinion will be revised and can be adopted, probably at the December BPC meeting, the agency predicts.


Chemical Watch: July 2017

Intertek is pleased to offer this complimentary webinar that will focus on the regulatory requirements (compliance of actives and labelling obligations) for the marketing of articles treated with biocidal products.

The Biocidal Product Regulation “BPR” (EU no 528/2012) concerning the placing on the market and use of biocidal products, sets rules for the use of articles treated with, or intentionally incorporating, one or more biocidal products. According to the regulation, articles can only be treated with biocidal products containing active substances approved in the EU. This is a change from the Biocidal Products Directive (repealed by the BPR from 1 September 2013), where articles imported from third countries could be treated with substances not approved in the EU.

Companies must be ready to provide the consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days. Manufacturers and importers of treated articles also need to ensure that products are labelled according to both the regulation on Classification, Labelling and Packaging and the additional requirements defined by the Biocidal Products Regulation.


European Coatings: July 2017

The assessment of biocidal active substances is regulated under the latest Biocidal Products Regulation (EU) No. 528/2012 (BPR). One-fifth of the over 50 active substances earmarked for in-can preservatives have been approved, demonstrating that the authorities seem to be adopting a strict approach. Biocidal active substances are needed more urgently than ever before in the paints and coatings sector. Solvent-based products are increasingly disappearing, for the protection of humans and the environment and as a result water-based systems are steadily becoming more widespread – but these require the use of biocidal active substances.

Biocidal products containing these active substances are used as in-can preservatives and film preservatives to prevent the formation of mould and algae in damaged paint and façade coatings, amongst other uses. The first active substance approvals for in-can preservatives are starting to impact companies in the form of restrictions.

Product-Types 6 and 7 – overlaps

In-can preservatives (product-type 6) are intended to protect water-borne paints in containers from microbial deterioration, which could otherwise discolour them or alter their viscosity. Film preservatives (product-type 7), by contrast, are intended to protect walls and facades from microbial deterioration and algal growth which would otherwise discolour the surface and damage the coating. Despite the different fields of application, there is substantial overlap as far as the active substances employed are concerned: the two most important of these are zinc pyrithione and the isothiazolinone class of substances. Active substances for approval for each product-type have been systematically reassessed over many years as part of the Existing Substances Review Programme. Active substances falling under product-type 6 are scheduled for review before those of product-type 7.

Particularly where identical active substances are concerned, current approvals results for in-can preservatives may suggest the results that can be expected for film preservatives. According to the timetable for the approval of active substances, all product-type 6 and 7 open approvals decisions must be made within the next five years. Initial results from the approval processes are falling in the direction of either the substitution of active substances or stricter classifications and labelling.

Exclusion and substitution

The exclusion and substitution of active substances presents a challenge, as they are essentially based on hazard criteria and not on a risk assessment. This points to a possibility that substance classes per se will be excluded. For example, the classification of formaldehyde as a carcinogen had a negative impact on the entire group of formaldehyde releasers that are used as in-can preservatives. Regardless of whether its use is in product-types 6 or 7, the future of zinc pyrithione as an active substance is still uncertain because it could suffer the same fate as that of the formaldehyde releasers. Zinc pyrithione is currently under review for a harmonised classification as toxic to reproduction, the outcome is still undecided.

Labelling limits – Tantamount to a ban

However, exclusion and substitution are not the only reasons for the substantial, continuous decline in active substances and families of active substances. Further restrictions on use result from the substance-specific labelling limits. For example, isothiazolinones are known to have a skin sensitisation potential and are rightly assessed very carefully. Dashing the hopes of the industry, however, the legislator has adopted a hazard-based rather than a risk-based approach to the assessment of active ingredients. Consequently, less importance is attached to use and safe handling than to the hazard potential. This is shown in the RAC’s proposal for the substance MIT. The isothiazolinone mixture CMIT/MIT has been subject to a labelling limit of 15 ppm since 2002 because of its high potential for skin sensitisation. The RAC is proposing to apply this limit to MIT as well, when in fact MIT is actually an alternative because of its lower skin sensitisation potential. Unlike CMIT/MIT, MIT in this concentration does not effectively preserve products during storage, and so the labelling limit is tantamount to a ban on MIT use by the public. It remains to be seen what decisions be will taken concerning the other isothiazolinones for both in-can preservatives and film preservatives. Decisions made to date would suggest that the choice of active substances available for the various applications will continue to shrink due to these labelling limits.

Assessing active substances in isolation

The question as to if preservation and film protection have been examined sufficiently in the round can be answered with a clear "no” for the moment. The problem with assessing active substances for the coatings industry in isolation is that any such assessment will mask a critical decline in the number of available alternatives, and this will only be realised when it is too late. In the case of in-can preservatives, the association’s present call for all active substances of a given product-type to be assessed concurrently is going unheeded. This request, aimed at keeping the big picture of possible preservative alternatives in mind, may also have an effect of the future of film preservatives. It would seem that currently everything in the industry is up in the air. Novel, innovative active substances will not be available in the short term and the hazard-based approach is not expected to be replaced by a more risk-based approach. The challenge facing the industry is to combine the few remaining active substances available with a view to covering a huge range of uses for in-can preservatives and film preservatives.