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Are you ready for EU Poison Centre Notification Format?

Consumers and workers come into daily contact with hazardous chemicals, and although they are expected to be used according to safe-use instructions, unintentional exposure may happen: ingestion, skin contact, inhalation, etc. In those cases, emergency professionals need rapid product identification, information about the chemicals contained and its hazardous properties, all these in order to facilitate the identification of the correct treatment and to avoid further damage.

And this is exactly what a poison centre does: it provides medical advice to citizens and healthcare professionals on health emergencies arising from exposure to hazardous chemicals or to other toxic agents; such as medicines, plants, bites and stings. Poison centres in the EU answer calls for support daily and around the clock.

On 22 March 2017, the Regulation (EU) nº 2017/542 was published, adding the Annex VIII, about the harmonised information relating to emergency health response. According to the ECHA, “It’s about harmonisation, and harmonisation brings synergies and efficiencies”. It was designed to regulate all hazardous mixture notifications (mixtures classified with health and/or physical hazards) within the EU, and established two new concepts related to chemical safety:

A harmonised information format file: a common format file which will gradually replace the current national requirements in force.
A Unique Formula Identifier (UFI): a unique code for each product which will be added on the label.

This new system, although efficient and beneficial in the long term, also implies a new complex notification process for companies, which will have to notify their products in the official language of each country in which they are marketed, pay different national taxes, etc. Providing harmonized information will certainty improve emergency health response, but the number of notifications is expected to significantly increase, and the producers and manufacturers who have started to work with the new system have already experience workability issues such us:

Insufficient time prior to deadline to assimilate notification tools.
Regular product variations that will lead to multiple and frequent changes of UFI for the same product.
Problems working with the ECHA Submission portal: navigation is complicated, too many clicks; it is not always directly clear if you made a wrong input, since validation is only available at the end of the process; notification via Guided Dossier Preparation took approx. 2 – 3 hours for a single product.

To overcome these inefficiencies and for the harmonized notification system to be truly useful for society, but also viable for companies, experts believe that there is a need for managed automation that minimizes the impact of:

Tens of thousands of products to be notified.
Frequent formulation changes. Partly own initiative, partly by raw material suppliers or driven by legislation changes.
Not feasible to do notifications & updates manually. Notifications must be generated in bulk.
Automation requires standardization. The solution must work for thousands of notifications at a time.

Time is running out, since the new harmonized notification process shall apply from 1 January 2021, after its publication in the Official Journal of the European Union. That is why we have updated CHEMETER, a reliable SDS authoring software which provides you with country specific legislation, up-to-date regulatory information, continuous new features development and professional assistance. It is also a friendly modular software which accommodates each company’s needs considering the country, sector and the aim of the company. It creates an extended range of documents; such as SDS, e-SDS, labels, dangerous goods documents and sector specific paperwork. It is one of the highest implemented software solutions worldwide, and now in addition, we have updated it to provide it with an additional module that issues automatic notifications in a few minutes.

The new module is specially designed to help users to comply with new poison Centre Notification Requirements for Hazardous Mixtures in the EU. It automatically creates PCN dossiers for harmonised notifications. Just in a few minutes, users will get the file with all the necessary documentation: automatic UFI code generation, toxicological information, complete chemical composition, etc. It is a simplified process, which indicates step by step in a simple way the data that the user needs to complete it. In a few clicks, users will get the file to notify all products. It is a significant time saver compared to the 2 or 3 hours it would take to generate the Poison Center Notification (PCN) format for a single product using the official portal.

You can get more information about CHEMETER and all Siam services on our website https://www.siam-it.com/en/.

Frequently Asked Questions of the KKDIK Regulation (Turkey REACH)

With the pre-registration deadline for KKDIK quickly approaching on the 31st of December 2020, we at CIRS are busy monitoring the latest updates and preparing you to fulfil all the necessary obligations. Completion of the pre-registration obligation provides you with a grace period for registration until the end of 2023 after which all chemical substances manufactured/imported to Turkey in one ton/year must be fully registered.

To make this process easier for you, we have gathered all the most frequently asked questions from our practical experience to-date with the KKDIK regulation.

If pre-registration is completed within C&L notification, then why should a foreign enterprise do the pre-registration themselves and not through a TR-importer?

If a TR-importer does C&L notification, they select the role of ‘importer’. The pre-registration will also have been completed under an importer. This may result in the following scenarios (a) higher cost for registration (b) the TR-importer may not do the registration and choose a supplier which has registered their substance with an OR (c) If the TR-importer does the registration, then they can buy the substance from any supplier they want as they will have the registration number. The result is an overall loss of commercial power in Turkey

How is the pre-registration/registration of a polymer processed according to the KKDIK regulation?

Article 4 (hh) of KKDIK: Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units, distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units and comprising of the following:

1) A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and

2) Less than a simple weight majority of molecules of the same molecular weight

According to the KKDIK regulation, polymers are themselves exempt from registration. In the same way as EU REACH, it is the monomer unit and any other substances which are present in 1 ton/year or greater which require pre-registration/registration.

For C&L notification of chemicals delivered in mixtures, does each individual substance require notification?

The way a mixture is classified is if the mixture contains a substance which is classified as hazardous and it is above the appropriate concentration limit (varies depending on the substance in question), then the mixture is classified as hazardous. If a mixture meets hazardous criteria, then C&L notification is required. Classification is the same as EU REACH.

Is it possible to transfer completed pre-registrations?

Currently, the online platform for submitting pre-registration/registration dossiers is updating. This is the KKS tool (IUCLID and REACH-IT hybrid). This may take some time to complete. The OR transfer function will be available after the update is complete.

According to KKDIK, all substances manufactured/imported into Turkey in 1 ton/year should be pre-registered. If my substance is less than 1 ton/year can it still be pre-registered?

Yes, it is still possible to pre-register substances which are less than 1 ton/year. This will also cover future business if annual tonnages rise to the 1 ton/year mark or above in the period of three years. If pre-registration is not completed before Dec. 31^st 2020 and tonnages rise above the 1 ton/year threshold, then full registration will be required which will be far costlier.

Is there a system of reporting dispatches into Turkey after pre-registration is completed?

Currently, there is not such a system in place for reporting dispatches

When dealing with a mixture, if a raw material is pre-registered under the supplier, can the pre-registration be used by the formulator of the mixture?

This is the decision of the supplier who obtained the pre-registration number and whether he grants access to the formulator to use the pre-registration number.

Who may register in the case of a multinational company/group companies?

This depends on whether each company within the same parent company are defined as ‘registrant’ according to Article 4(ü) of the KKDIK regulation. If multiple companies are under the same legal entity, then just one company needs to act as the registrant. In the case of a separate legal entity, such as a sister company, they should also register.

How are alloys registered?

According to the KKDIK regulation, alloys are treated in the same way as mixtures. Therefore, each individual substance i.e. each metallic substance must be registered individually.

If the tonnage band is expected to increase in the future, can the higher tonnage band be registered under instead?

Companies may register under higher tonnage bands if they expect their annual tonnage to increase. The higher registration fee must also be paid. Furthermore, the registration dossier must include all the required information for the higher tonnage band as data requirements differ between tonnage bands.

If a company is importing a mixture to Turkey, how can they find out if the individual components have already been registered in Turkey by the supplier, if the supplier is refuses to share the information?

The options are to (a) Contact the formulator where the supplier is not the same entity as the formulator. The formulator may be more willing to share the composition information. (b) Take analytical measurements to determine the composition of the mixture or (c) Find an alternative supplier of the same substance who is willing to share the information

Our substance only has a CAS No. and no EC No. is available, can we process pre-registration only with CAS No.?

Yes, there is no problem to process pre-registration without EC No.

We are a distributor located outside Turkey, can we appoint an OR and process pre-registration?

No. It’s same as EU REACH. Only foreign manufacturers can appoint an OR and process pre-registration.

Is there a definition of “new chemical” in the KKDIK regulation?

No. The regulation is only about the substance. There is no specific definition of Existing Chemical and New Chemical. CIRS suggests companies to process pre-registration of all their substances.

If the manufacturer completes the pre-registration, can the local importer take C&L notification with this pre-registration No.?

No, if the importer processes C&L Notification, they have to firstly complete pre-registration by themselves.

Our product contains a raw material which has not been reacted. The tonnage of this raw material is more than 1 ton/year. Are we still required to process pre-registration of this raw material?

It’s similar as EU REACH. If the raw material is not residual on purpose, it can be regarded as an impurity and pre-registration will not be required.

We are a Turkish legal entity which owns several factories in different sites, how shall we process the pre-registration?

According to KKDIK regulation, registrant shall be the natural or legal person in Turkey. If the company has one individual legal entity which own different factories, and the factories have no individual legal entity, only one pre-registration is enough, and all factories will be covered.

If you have any further questions, please do not hesitate to contact us:

Julie Harrington, Regulatory Affairs Consultant

julie@cirs-reach.com

+353 0 87 197 2618

https://www.linkedin.com/in/julie-harrington-14270a160/

Safety, Regulatory and Safe Handling of Chemicals

Safety, Regulatory and Safe Handling of Chemicals are topics that constantly challenge the global Chemicals industry at all times.
There is a need for companies to understand the correct regulatory, classification, symbols and pictograms. It’s not just enough to write SDSs ‘in-house’ without employing proper tools or knowledge resources or simply copy-pasting safety data sheets from competitors, suppliers or from the internet as these could be quite misleading! Yet another requirement for companies aspiring to get various types of Quality, Compliance, other certifications is to have proper systems in place including those of Safety, Regulatory and Safe handling of Chemicals regardless of being hazardous, non-hazardous chemicals or both.

SIAM SL, Spain based in the world famous La Rioja wine region of Spain develops IT Solutions and Software for the automatic Classification, Formulation and Authoring of Safety Data Sheets for single substances and mixtures falling under CLP and GHS regulations. SIAM provides a highly versatile software (CHEMETER) for preparing multilingual SDS in over 55 world regulatory/languages and multilingual product labelling and provides SDS AREA, a platform for easy distribution and management of Safety Data Sheets.
Both CHEMETER and SDS AREA solutions offer major time-savings to companies over traditional methods of authoring SDSs as well as using old software since both solutions come with latest features suited to the current and evolving safety regulations in over 55 countries. CHEMETER software is easy to understand, open and flexible and built-up in a modular fashion to suit your exact needs at any given time.

1000+ clients across 45 countries that use CHEMETER software and SDS AREA include a variety of manufacturers, exporters, importers, distributors, traders, MSME’s, OEM’s into all kinds of Chemicals, API’s and Plastics and coming from all walks of industry including CASE, Petrochemicals, Pigments, Resins & Additives, Dyes & Dispersions, Textile and Leather Chemicals, Cleaning & Construction Chemicals, Lubes & Greases, Cosmetics, Solvents, Rubber, Plastics, Detergents, Flavours & Fragrances, Water Treatment Chemicals, Agro Chemicals, Monomers and Polymers, Resins and more.

Come 1^st November 2020 and CHEMETER software will offer its users an additional module specially designed to help users manage the EU’s new regulation of UFI (Unique Formula Identifier) Code in order to comply with the EU’s new Poison Centre Notification (PCN) requirements for hazardous mixtures being supplied into the EU. The module automatically creates PCN dossiers for harmonised notifications and within a few minutes, users can upload files with all necessary documentation, automatic UFI code generation, toxicological information, complete chemical composition, etc. It is a simplified and easy step-by-step process and significant time-saver compared to the 2-3 hours odd it otherwise takes to generate PCN for a single product using the official portal.

You can get more information about SIAM’s Regulatory IT Solutions on https://www.siam-it.com or by sending an email to:

Nirav Banker
(UK, Asia & Middle-East Business Head)

Email: n.banker@siam-it.com
UK Mobile: (+44) 747 096 4875

Siltech – Silicone Amines for Coatings

Silicone amine polymers are an interesting category of materials within silicone chemistry.
They tend to provide the very best handle and softness to textile substrates.
They are also quite hydrophobic, so are used in applications such as car care.
They can additionally be used as reactive components in resins.

Broadly speaking, there are 5 categories at Siltech, as follows:

1 – Aminoethyl aminopropyl-based, with structure as shown:

“a” and “b” can be varied. Silamine 2972 and Silamine MUE are good examples within this product group.

2 – Reactive amino-functional prepolymers, with structures as shown below:

There are a multitude of types, and these can be co-reacted into coatings and resins in order to provide flexibility and add impact resistance.

3 – Silicone polyether amines, as shown here:

In this case, the aminoethyl aminopropyl groups are “solubilised” with polyether groups. For example, Silamine D208 EDA is water-soluble. These types are also reactive (carbinol functional), and a, b, c, d and e can be varied.

4 – Silicone alkyl amines have alkyl groups in addition to the amine functionality, in order to improve organo-compatibility. Silamine T-97 is one example, and Siltech has made a series of these products.

5 – Fluorosilicone amines are niche, but Silmer NHF Di-H1 is one example, which has pendant fluoro groups and terminal allyl amines.

Please contact dave.wilson@siltech.com

Siltech – Silicone Film Formers for Coating Applications

Siltech Film Formers are designed to coalesce and react on hard surfaces such as concrete, porcelain, wood, countertops, or rubber, and flexible surfaces such as fabric, paper or leather.

The products are all provided in dispersible or dilutable emulsion form.

Typical properties include:

Release
Slip
Anti-squeak
Anti-stain
Softness
Hydrophobing
Gloss
Flexibility

Here’s a table which summarises the various types:

Please contact dave.wilson@siltech.com

Siltech – Using SilmerTM Reactive Silicones to Modify Coatings

Silicon and Carbon are the in same column of the Periodic Table, and so the chemistries of Si and C are very closely related. Siltech builds upon this similarity in the “Silmer”^TM reactive line of products, in order to manufacture numerous functionalised pre-polymers. The resultant silicones can be co-reacted into analogous non-silicone systems in order to improve slip, flexibility, abrasion resistance, release, and hydrophobicity.

In the most general terms, the Silmer^TM reactive pre-polymers are either multi-functional or linear di-functional, and there is an ever-increasing list of functional types, including the following:

Hydroxyl (carbinol) OH
Tetra Hydroxyl (carbinol) OHT functional, for better network formation and improved organo-compatibility.
Acrylate ACR
Tetra Acrylate ACRT
Hydroxy OH ACR Acrylate functional.
Hydride H
Vinyl VIN
Isocyanate NCO
Amine NH
Epoxide functional, both glycidyl-based EP and cycloaliphatic-based EPC.
Trimethoxysilane TMS and Triethoxysilane TES
Thiol SH
Carboxy COOH

Please contact dave.wilson@siltech.com to discuss any of these products.

Exhibitors

Company Name	Stand
BTC Europe, a brand of BASF	201
Cardolite Specialty Chemicals Europe	320
Cornelius Group Plc	317
DKSH Great Britain	321
IMCD UK Limited	208
Safic Alcan UK Ltd	300
Univar Solutions	217