Through our close business partners at the Korea Institute of Science and Technology (KIST), we learn that significant amendments are to be expected in the South Korean chemicals regulation known as K-REACH. In many ways, K-REACH is similar to the European REACH Regulation, but not as stringent. With the proposed amendments, however, a tightening of K-REACH is to be expected.

Registration of all substances in Korea
At the turn of the year, the South Korean Ministry of the Environment quite unexpectedly announced a public hearing of proposed amendments to K-REACH. Most notably is the proposal for registration of all substances above volumes of one tonne/year. Previously, only selected substances above one tonne were subject to registration. Similar to the EU REACH Regulation, registrations according to tonnage volume are expected to be phased in over a number of years:

• Substances over 1,000 tonnes/year: 2021
• Substances over 100 tonnes/year: 2024
• Substances over 10 tonnes/year: 2027

Other key changes include:

• Preregistration of all existing substances on the South Korean market, possibly already from 2018.
• Increased requirement for information in the supply chain about safe use of substances and mixtures. If mixtures are included, the requirements in K-REACH will be more precise than in the EU REACH. It has been observed that in the EU the end user does not receive exposure scenarios communicating conditions of safe use of the chemical products.
• More information to consumers about substances of high concern in products.

The incentive for the changes is a number of very serious accidents connected to the use of chemicals, which has triggered the South Korean authorities to put forward the proposed amendments.

If the amendments are passed, the new law may come into force already next year.

For more information about K-REACH, please contact

Jens Tørsløv
jet@dhigroup.com
Tel +45 4516 9022

Bisphenol A is one of four new substances that were included in the Candidate List in January. As a result, bisphenol A (BPA) is drawing closer to entering the Authorisation List of the EU REACH Regulation. When this happens, users will need to apply for permission for continued use of the substance.

With the inclusion in the Candidate List, companies may already have legal obligations to fulfil. If you are a supplier of articles containing BPA in a concentration of 0.1%, you have communication obligations in the supply chain to customers and consumers. Likewise, if you import or produce articles with BPA, you have six months from 12 January 2017 (the date of inclusion in the Candidate List) to notify the Euro­pean Chemicals Agency (ECHA).

For more information, please contact

Brian S. Nielsen
bsn@dhigroup.com
Tel +45 4516 9140

Based on our experience in setting up consortia for industry clients and obtaining authorisation of biocidal products and biocidal product families, we are forming new biocide consortia. In the consortia we will act as facilitators for handling of confidential information, consortia management, communication with regulatory bodies etc.

The benefits of consortia for biocidal product families include shared costs, while at the same time enabling you to maintain individual product authorisations independently.

The new consortia are targeted producers, distributors and formulators placing biocidal products on the market. It will be of particular interest to small and medium sized enterprises (SMEs) within biocidal products and biocidal product families.

For more information on substances and services provided, please read here: Biocide Consortium – Call of Interest.

You are also welcome to contact

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156

ECHA has published a specific guidance on how to evaluate Disinfection By-Products (DBPs) produced during use of disinfection products authorised under the European Biocidal Products Regulation (BPR).

The guidance provides a scientifically based strategy for the environmental risk assessment of DBPs. The risk assessment of DBPs follows the scenarios applied for the active substance. The guidance focuses on the product types PT2 (disinfectants and algaecides), PT11 (preservatives for liquid-cooling and processing systems) and PT12 (slimicides) for which environmental exposure was considered most relevant.

Other product types for which a DBP-assessment may be needed are PT1 (human hygiene), PT3 (veterinary hygiene), PT4 (food and feed) and PT5 (drinking water).

Link: Guidance on the Biocidal Products Regulation - Volume V, Guidance on Disinfection By-Products

For more details on environmental risk assessment, please contact

Dorte Rasmussen
dor@dhigroup.com
Tel +45 4516 9316

Since the first reported cases in 2010, a complicated issue of Nontuberculous Mycobacteria (NTM) infections during cardiothoracic surgery has been a mystery. Several years of interdisciplinary detective work now elucidates the problem which is associated with heater-cooler devices.

The transmission of Mycobacterium chimaera (a type of NTM) to patients during open thoracic surgery has been linked to the use of 3T heater-cooler units, and the following issues have been identified as potential root causes:

• NTM bacteria transmitted through air (aerosolisation). For example, mycobacteria are found in much higher concentrations on water droplets ejected into the air from air bubbles rising and bursting in the tank as compared to the concentration of mycobacteria found in the water.
• Laminar flow disruption.
• Heater-cooler design (fans and filters).

As a result, additional risk assessments before and after putting heater-cooler devices into clinical use will be necessary. Growing evidence of contamination with diverse non-tuberculous mycobacteria and other opportunistic pathogens suggest a wider aerosol-borne infectious hazard from water-containing devices used in surgery.

For more in-depth details, please see the following links:

• Mycobacterium Chimaera Infections Associated with Heater-Cooler Units (HCU): Closing Another Loophole in Patient Safety, published in Eurosurveillance, November 2016

• FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices

For more information on risk assessment of medical devices, please contact

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103

DHI have assisted the Danish Environmental Protection Agency in preparing safety assessments of three fictitious cosmetic products. Furthermore, 10 European authorities have contributed with comments and input.

The safety assessments of the fictitious products are guidance documents. They document the exhaustive work of preparing safety assessments and the level of knowledge required to do so. The aim is that the assessments can serve as an inspiration and guidance on how to address this task.

The three safety assessments comprise a shampoo, a hand cream and a baby body lotion.

In addition, we have developed a tool to create and store data on toxicological profiles and cosmetic ingredients and safety profiles for cosmetics. The tool is useful for preparation of safety assessments.

For more information on safety assessment of cosmetics or our new tool, please contact

Dorthe Nørgaard Andersen
dna@dhigroup.com
Tel +45 4516 9088

Because of the restriction in the use and subsequent phase-out of brominated flame retardants (BFRs), interest has increased to use PFRs as alternatives to BFRs, due to their technical characteristics. Although PFRs have been used worldwide for many years, data on their environmental persistence and toxicity are limited. Studies indicate, however, that several PFRs are suspected of being carcinogenic, neurotoxic, endocrine disrupting and/or highly toxic to the environment.

In the study Dietary intake of phosphorus flame retardants (PFRs) using Swedish food market basket estimations, the Belgian/Swedish team analysed eight PFRs in food samples from 12 food categories. Measurable levels of PFRs were found in several of the food groups, and especially cereals, pastries, sweets and beverages contributed to the PFR intake. Foodstuffs may be contaminated by bioaccumulation of PRFs in food of animal origin or during the food treatment processes and packaging.

Although the exposure to PFRs in food is much lower than the reference doses, food is just one route of exposure. Other important exposure routes to these substances include dermal contact and dust ingestion/inhalation.

For more information on substitution and dietary exposure, please contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097

The EU Reference Laboratory for food contact materials (EURL-FCM) has investigated the release of metals from ceramics into food and simulants. The aim is to develop adequate methods for testing in order to be able to enforce future lower limits for release of metals.

A total of 73 ceramic samples were tested, including hand crafted samples. Tests were performed with acetic acid and citric acid as simulants and tomato sauce as benchmark food. The comparison between the two simulants and the tomato sauce showed that migration of metals was higher in both simulants. It was, however, difficult to predict release during repeated tests partly due to the heterogeneity of the samples, partly because the relationship between the results of the first and third release tests was not always constant. Results also showed that at least four replicas of each is necessary for testing.

In addition, the study investigated whether there was any difference in release between daily or less frequent use of the ceramic articles. No significant difference could be observed.

View the full report from EURL-FCM and the European Commission: Testing approaches for the release of metals from ceramic articles is available

For more information of migration of metals and substances, please contact:

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097

From 1 August 2017, new EU rules will become effective concerning denaturation of alcohol. Per hectolitre of absolute ethanol, the following substances must be added:

• 1.0 litre isopropyl alcohol
• 1.0 litre methyl ethyl ketone
• 1.0 gram denatonium benzoate

It is also possible to add a dye to the denatured alcohol to give it a distinctive colour and to make it easily identifiable.

For full details, please refer to Regulation (EU) 2016/1867.

For more information, please contact

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103

For more information on our courses, please click here.