K-REACH: How to Register in 12 Easy Steps

In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment. This legislation was revised to impose stricter controls on a broader range of substances, effective January 1, 2019.

Continue reading

How to Renew Plant Protection Products – EU Regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing and sales of PPPs, a renewal of authorization of the ASs must be sought. This renewal procedure is covered by Commission implementing Regulation (EU) No. 844/2012 and is a European-level process.

Continue reading

Understanding Biocidal Products Regulation (BPR) in the EU

BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and understand the information required.


Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful to the health of humans or animals, the environment, or that cause damage to . As such, biocides play an important role in everyday life and reflect a huge range of product types, from disinfectants to insecticides.

The European Chemicals Agency (ECHA) regulates the specific biocide products that are available in the EU/EEA and Switzerland, as well as the active substances that they contain, under the Biocidal Products Regulation (BPR). The aim of the BPR is to ensure that all marketed biocidal products perform their intended role (i.e., have efficacy) and pose a low hazard to humans, animals and the environment when used as specified.

Quick Overview of BPR

The EU Biocides Regulation 528/2012 has been in effect since September 2013. It has a two-step process requiring at first an active substance application, and secondly the authorization of any biocidal products containing that active substance. The regulation also allows for the authorization of biocidal products as a biocidal product family. A product family allows the authorisation of multiple biocidal products within one submission. All products within the family must contain the same active substance(s) but can appear at different concentrations. If your product is identical to an existing formulation, but marketed under a different trade name, it is possible to apply for a same biocidal product authorization, which can reduce administrative burden.

You can choose to authorize products at a national level (which is beneficial in cases where the product is marketed in a few EU/EEA countries) or at Union level (which covers the entire EU/EEA and Switzerland). Up to the end of 2017, total of 115 Union authorizations for biocidal products had been submitted – of these 83% were submitted for biocidal product families. This may illustrate the attraction of the lower administrative burden and cost associated with a product family authorization.

Union and National authorization require submission via R4BP to a competent authority in a member state. There are some practical and logistical variations in how different member states approach BPR, so it’s worth considering the options available to you before you settle on a specific one.

Biocide Categories and Product Types

Annex V of the BPR contains 22 different product-types (PT) which fall into four main groups;

  • Disinfectants (PTs 1–5): for disinfectants in human and veterinary hygiene, surface disinfectants, drinking water disinfectants and for disinfectants that may enter into contact with food
  • Preservatives (PTs 6–13): biocides used to maintain product shelf-life (other than food or feed), protect construction materials or textiles, preserve wood and prevent slime growth
  • Pest control (PTs 14–20): for rodents, birds, fish, molluscs and insects
  • Other: for biocidal products which don’t fit within the other groups and include antifouling products (PT 21) and embalming fluids (PT 22)

Union Authorization (UA) is not an option for active substances within PTs 14, 15, 17, 20 and 21. Union authorization becomes an option for PTs 7-13, 16 and 22 from January 1, 2020 with all remaining PTs currently able to apply for UA.

Testing Under BPR

For authorization of a biocidal product, you need to provide all the information requirements set out by ECHA. There are two main data sets which are included within the IUCLID dossier – the core dataset (CDS), which all products require, and the additional dataset (ADS), which depends on the PT, its use, type of formulation and application method. Table 1 summarizes the analytical requirements, for both CDS and ADS, for biocidal products and active substances.

Table 1: CDS and ADS analytical methods for active substances and biocidal products

In addition to the IUCLID dataset, a risk assessment and a summary of product characteristics (SPC) are also required. The most time-consuming data to collect relates to long-term stability. These tests take two years to conduct, so forward planning for BPR submission is essential.

Conclusions

There are multiple things to consider when navigating your biocidal product through BPR – focus on gathering the right information and selecting the most appropriate authorization approach for your product, and consider the value of the biocidal product family approach.

Visit our website for more information about Covance’s regulatory services for crop protection.


About the Author

David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families.

How to Renew Plant Protection Products – US Regulations

Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.

Continue reading

ECHA Decision Letters – What to Expect

The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.

Continue reading

Field Trials for Crop Residue Analysis – What Are the 7 Secrets to Success?

Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).

MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?

Continue reading

New REACH Nanomaterial Requirements: What You Need to Do

The New EU Nanotechnology Regulation

On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.

Continue reading

What the New EU Endocrine Disruptor Assessment Means for Renewal of Your Active Ingredients

Introduction

The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2].

The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria apply to new active ingredients (AIs) and those going through renewal (). So, if the AIs in your plant protection products (PPPs) are due for renewal you need to understand the new requirements and how you can meet them.

Continue reading

What You Need to Know About Neonicotinoids and The EU

Photo of a bee

Introduction

Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species.

The agricultural and environmental consequences of neonicotinoid use and the recent EU regulatory restriction have made neonicotinoids one of the most controversial areas of science and policy.

Continue reading