Updates on New Chemical Requirements for REACH Compliance | APA Engineering
 

The European Chemicals Agency (ECHA) has updated its REACH compliance requirements for Nano forms of substances on 1st January 2020. As per the new REACH requirements, companies are liable to provide more data on the Nano forms in their possession. The main purpose of this new requirement is to ensure that companies across the globe are providing adequate data to showcase safe practicing of their Nanoforms for the safety of human health and the environment.

ECHA is forecasting to receive updated registrations for approximately 300 substances, based on the data received from the national inventories of Belgium and France, as well as the European Commission’s catalog of nanomaterials that are used in a multitude of cosmetic products.

What is Nanomaterial?

Nanomaterials are defined as chemical substances or materials that possess a particle size that falls between 1 to 100 nanometers (nm) in at least one of the three dimensions.

Nanomaterials may possess different characteristics based on their increased specific surface area by volume, when compared to the same material without having the features of the nanoscale. As a result, the physicochemical properties of these nanomaterials may differ from the properties of bulk substances or particles of a larger size.

The European market is already flooded with everyday products that contain nanomaterials, such as cosmetics products, coatings, batteries, antibacterial clothing, and much more. It is true that nanomaterials provide businesses with elaborate commercial and technical opportunities, but they also pose a significant risk to human health and the environment. Hence, to intrinsically monitor and assess the use of nanomaterials, REACH requirements play a crucial role to adequately control any risks posed by this material.

To help implement and monitor the chemical legislation for nanomaterials, ECHA actively collaborates with the European Commission, Member State Competent Authorities, various NGOs, and industrial associations along with international organizations such as the Organization for Economic Cooperation and Development (OECD). This helps ECHA in not only ensuring adequate compliance is followed by companies, but also provides them an extra hand in establishing the REACH compliance requirements across the continent with convenience.

Nanomaterials under Biocidal Products Regulation (BPR):

BPR has generated specific provisions for nanomaterials compliance. These provisions are directly targeted towards products and substances that precisely meet the criteria that are defined under the BPR. These criteria are established on the recommendation of the Commission’s definition of nanomaterials. These are applied for active and non-active substances that possess the following attributes:

●  If 50% or more of the particles have a size of 1-100 nm in at least one dimension

●  If the particles are in an unbound state or exist as an aggregate or agglomerate

The Commission may adapt to this definition and characteristics based on technical and scientific development, while it may also accept a decision of deciding whether a specific substance is a nanomaterial at the request of a Member State.

An active substance’s approval under the BPR doesn’t cover the nanoform of the same substance unless and until it is explicitly mentioned. It is deemed necessary to prepare a separate portfolio or dossier for the nanoforms present in the active substance with all the new data requirements. After this process is carried out, if the active or non-active substance has been used in the making of any biocidal products, a dedicated risk assessment is carried out to identify any risk factors in the product. Hence, the label of the biocidal products should also show the name of every nanomaterial present in it, which should be followed by the word “Nano” in brackets. Following all these protocols can help the biocidal products containing nanomaterials in getting exempted from the simplified authorization procedure as well.

How BPR is Reported and Monitored

The Member States are liable to report on the implementation of the BPR in the products developed every five years. This reporting must include data and information pertaining to the use of nanomaterials in biocidal products, and the potential risks that might have been identified with full transparency. These reports are to be submitted to the Commission by the 30th of June of the relevant year, and will cover the five-year reporting period until the 31st of December of the year preceding their submission.

Nanomaterials under CLP and REACH Requirements

In the year 2011, a recommendation was released by the European Commission for setting up an acute definition of nanomaterial. Nanomaterials fall under the existing definition of a “substance” under REACH and CLP, and the provisions set by both the compliances apply to them. This has significantly helped in harmonizing how nanomaterials are often defined across the various legal frameworks in the European continent.

Companies that either manufacture or import any nanoforms fall under the REACH compliance, as is explicitly stated in the legal requirements under REACH, as of 1st January. The purpose of these reporting obligations is to precisely address specific REACH requirements which are visibly outlined in the revised annexes of the REACH regulation:

●  Characterization of nanoforms or sets of nanoforms covered by the registration (Annex VI)

●  Chemical safety assessment (Annex I)

●  Registration information requirements (Annexes III and VII-XI)

●  Downstream user obligations (Annex XII)

All of these regulations apply to all the existing and new registrations, covering nanoforms.

ECHA's activities on nanomaterials under CLP and REACH requirements

REACH and CLP processes have their importance. If you are wondering about how to determine REACH compliance, the first step is to check if the following factors are a part of the process or not:

●  Registration

●  Evaluation

●  Authorization

●  Restriction

Similarly, the following factors for CLP will help you determine the compliance:

●  Classification

●  Labeling

Since both of these compliances cover nanomaterials, it is clear that ECHA needs the ability to successfully carry out its multitude of tasks for nanoforms within the CLP and REACH processes, just like it would need to for any other form of a substance. It is also prevalent for ECHA to have sufficient scientific and technical capacity to carry out the aforementioned tasks.

Keeping all the aforementioned factors in mind, ECHA has significantly increased its activities pertaining to this domain since 2011, by focusing on the following factors:

●  Charting and preparation of updated guidance documents

●  Sharing the overall experience and generating a common consensus amongst the Member State Component Authorities, along with the Member State committees and members of the risk assessment authorities concerning the safety information in the REACH registration dossiers for nanomaterials

●  Adequately providing proper feedback and advice, if needed, to the entities that register nanomaterials

●  Actively participating along with contributing to the various ongoing international activities like Malta Initiative for developing testing guidelines or the OECD Working Party on Manufactured Nanomaterials

●  Webinars to inform and discuss the latest developments regarding REACH and CLP processes related to nanomaterials, and to help registered companies prepare and submit dossiers that involve nanomaterials

●  Hosting the European Union Observatory for Nanomaterials to increase the transparency of information on nanomaterials

Now that you are aware of all the processes that go into matching with the REACH compliance requirements, you can rest assured that APA Engineering will consult and guide you over all the grounds for matching up with the ECHA requirements and seamless operation with nanomaterials.

   

If this regulation is applicable to you and you are interested in knowing more about this topic and available solutions, then schedule a free consult with our experts.