REACH consultancy
We will ensure your continuous compliance with REACH regulation so you can focus on your everyday job!
Most likely you are one of those employees with endless tasks at hand, who performs his/her job with strong responsibility and integrity. Otherwise you would not have been chosen to manage the tasks related to REACH. Despite the fact that you have demonstrated your expertise and responsible attitude time and time again, with regards to REACH even you have doubts sometimes. This is comes as no surprise, of course. Even though you may be able to read the 800-page description of the Regulation in your own language, it is certainly difficult to find time to study the over 2000 page long English language guidance. In the case that you manage to participate in REACH conferences, you may receive the guidelines, but the work itself is still waiting for you to complete at home.
Good REACH strategy = Profitability, Staying in Business
Bad REACH Strategy = Financial Loss?
You have probably passed the pre-registration successfully. You are sitting in several (PRE)-SIEFs and now is the time to decide wisely “What should be the next steps?” As a responsible representative, you are well aware of the fact that with a good REACH strategy you can save significant amounts of money for your company. In fact, it may depend on your decision whether the import or production of a particular chemical substance remains profitable in the future. You can feel the pressure, yet you aren’t always able to provide your management the necessary information to make the best decisions. All this at a time when deadlines for the REACH registrants are coming closer and closer.
What are ways to drastically reduce REACH registration costs?
I have seen with many of my clients, that after they successfully complete the pre-registration, they become confused at the registration stage and have difficulty recognizing their own interests. They don’t realize what enormous amounts of money they can save by clarifying the following questions.
5 recommendations that may save millions for your company during the REACH registration
- Very often company representatives don’t realize that their firm may be exempt from REACH registration. With many companies we were able to cross off certain substances from the registration list, after reading together the options for exemption described in Section 2 of REACH and also in the revised Annexes IV and V of REACH. If you have not done yet, make sure to read the options for exemption from registration in order to avoid paying out millions for no reason.
- To be safe, many firms pre-registered the impurities and additives. This is not a problem, even though theoretically impurities and additives do not need to be registered, even if their annual quantities based on percentage composition exceed 1 ton. In general we can say that, according to REACH, an 80% composition substance is still called mono-constituent, meaning that up to almost 20% of the chemical substance produced by the company can be made up of impurities and additives.
- In several cases, if I don’t ask, companies don’t realize that the substance they produce may qualify as intermediate according to REACH, despite the fact that the substance is sold to other companies and it is transported outside the company premises. This is a very important factor, because intermediate registration costs significantly less. If your buyer is producing a new chemical substance from your chemical substance, then your company has a good chance for the much cheaper intermediate registration.
- In the case of substances in plant protection and biocidal products requirements similar to REACH have long been implemented. Therefore it is important to check whether another company may have already completed the registration.
- Importers are typically unaware that if they receive a notification that a non-EU partner has assigned an “only representative”, in this case they become exempt of the REACH registration, as long as they buy from this partner. This is also an important strategy for EU companies in trying to force the non-EU partners to assign REACH only representative.
Have you checked these for your company yet? If not, make sure to do it now!
If you have doubts regarding the above list, do pick up the phone or write me an email, I’ll be glad to help you. As a devoted REACH consultant, I have a lot more time to study all details of the REACH regulation and its instructions to be able to help my clients. Thinking together, we can decide what may be the best REACH strategy for your company, saving you time and money.
Preparation of REACH Mini Registration Dossiers, that is quick, professional registration at a minimal cost!
REACH registration is much more complex than we first thought. Without the help of a good consultant, or participating at REACH conferences on a regular basis it is a brave decision to complete a mini registration dossier, unless you are aware of the errors, which cause the rejection of many registrations. If you are a REACH registrant, I can help you with the registration process, you only need to sign up for my newsletter and I will send you a small summary of my recommendations.
What is the process of the REACH registration?
The main tasks in the registration process are as follows:
collect the information regarding the pre-registered substance, perform the tests, prepare the registration dossier and send it to the European Chemical Agency
The REACH registration dossier should be prepared through the IUCLID 5 and REACH-IT programs. There are two kinds of registration, the individual submission and joint submission. Individual submission is only possible if the company is able to give a reasonable justification to ECHA, otherwise joint submission is required, which is also cheaper than the individual submission.
In case of a joint submission the SIEF members choose a lead-registrant, who would be responsible for preparing the “full” registration dossier. First, the lead-registrant must submit the registration dossier. The rest of the SIEF members can submit their „mini” registration dossier after the lead registrant submission.
The REACH “mini” registration dossier should be prepared by all SIEF members, despite the fact that the lead registrant submitted a “full” dossier about the same chemical substance. When the lead-registrant prepared the “full” dossier, the SIEF member who paid for the tests will receive a “token” number. With this “token” number the SIEF member is able to certify that he is allowed to reference the toxicological tests of the lead registrant.
From this process you can see that the submission date of the “mini” registration dossier depends on the submission date of the lead-registrant, since the mini dossier can only be submitted after the lead-registrant submitted the “full” dossier.
What you need to know to complete the mini registration dossier without assistance?
- You must install on your PC the IUCLID program. You can download the program for free from www.iuclid.eu, but it is advisable to assign an IT specialist for this task.
- You must learn to use the IUCLID program. It is not even that simple when doing it by yourself, since you must study a 2000 page instruction manual to be able to use the program.
- If you decide not to spend one week to study the IUCLID program, you must participate in an IUCLID training.
- If you have successfully acquired all skills to use IUCLID, I would like to raise your attention that preparing the registration dossier may theoretically be simple, but in practice it is not at all straightforward.
Submitting the REACH registration dossier successfully for the FIRST try!!! Not impossible but…
If you are preparing the REACH mini registration dossier alone, you must learn to use the IUCLID program, study the instructions related to preparing the exposition scenario, gather its uses, have discussions with the labs regarding the identification of the substances, and even if you feel like you understood and know all, you may face a possible dossier rejection for the first try.
REACH registration is much more complex than we initially thought, without a good consultant or regular participation at REACH conferences it is a brave decision to complete the mini registration dossier alone.
Do you find it easier and safer to ask a consultant to prepare your Mini Registration Dossier?
You may enjoy the following advantages if you chose to have my company1 as your consultant to prepare your mini registration dossier:
- You do not need to learn the IUCLID program (2 days of your life saved)
- You do not need to correspond in English with the lead registrant as we will do that for you
- We will revise the results of the analytical tests necessary for the substance identification, will inform you if they are not appropriate, and will organize new tests if necessary
- We will prepare or discuss with the lead registrant the exposition scenario
- We will describe the most simple method of gathering the uses
We will ensure 100% money back guarantee that your registration dossier will successfully pass first. This means we will return your money if the submission does not pass for first trial.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
You don’t want to be a lead registrant but maybe you have no choice?
I can help you with the decision, what may be your tasks:
Being a lead registrant is not an easy task, this is probably why in many SIEFs the lead registrant has not been appointed yet.
At the following link you can see if there is already a lead registrant in your SIEF »
What should I do if there is no lead registrant in the SIEF related to my activity/company?
On REACH-IT you can look up the email addresses of all SIEF members and you can contact them directly. You can also find out on REACH-IT whether any of the companies has started to organize something in one of the SIEFs. The main point is, you should find out as soon as possible if there is already a lead registrant, as choosing one cannot be avoided, it is usually a common interest.
If your company is a European producer, and it seems that none wants to take the role of the lead registrant, you must immediately report this to your management as it can happened that your company must take this role as long as no other firm is involved in the production of that particular substance. Being the lead registrant means significant financial expenditures, which the company management must plan well in advance.
What additional tasks and expenses should you expect as a lead registrant?
The lead registrant has two main tasks. One of them is to reduce the number of tests and have them completed in a way that it is still compliant with REACH requirements and the full dossier can be submitted. The other task is to communicate with SIEF members regarding the dossier submission, using the help of a SIEF facilitator. The communication is possible via email or other free web surfaces developed for SIEFs, depending on the number of SIEF members.
Gathering the necessary tests
The most simple is if the SIEF members are in possession of the necessary tests, in this case they only need to agree about the division of the data and the costs.
ECHA warned that clock is ticking. What is the rush?
For the lead registrants it is important to submit the full dossier, because until this is not done, the rest of members can also not submit their mini registration dossier.
What is the process of the REACH registration?
The REACH registration dossier should be prepared through the IUCLID and REACH-IT programs.
In case of a joint submission the SIEF members choose a lead-registrant, who would be responsible for preparing the “full” registration dossier. First, the lead-registrant must submit the registration dossier. The rest of the SIEF members can submit their „mini” registration dossier after the lead registrant submission.
The REACH “mini” registration dossier should be prepared by all SIEF members, despite the fact that the lead registrant submitted a “full” dossier about the same chemical substance. When the lead-registrant prepared the “full” dossier, the SIEF member who paid for the tests will receive a “token” number. With this “token” number the SIEF member is able to certify that he is allowed to use the toxicological tests of the lead registrant.
From this process you can see that the submission date of the “mini” registration dossier depends on the submission date of the lead-registrant, since the mini dossier can only be submitted after the lead-registrant submitted the “full” dossier. If a company in a pre-SIEF has volunteered to be the “facilitator”, this does not mean that this company is the lead registrant. Lead registrants are theoretically chosen by the SIEF members.
It is common in many pre-SIEFs that a few companies form a consortium for easier cooperation. One independent consultant keeps in contact with the members of the consortium (who are competitors) in order to avoid the accusations of cartell formation. The consortium can deal with several substances. It is not compulsory to participate in the consortium.
The lead registrant is required to ensure access for all SIEF members to the “token” number, if the company has paid, when the lead registrant hands to the SIEF member a “Letter of Access”.
Assume that your Company must become the lead registrant, as none took the role in the SIEF and you want to produce the given substance.
What costs can you expect?
The cost of the full toxicological test of a substance is approximately 60 000 – 200 000 Euro ( 1-10 t/y and 10-100 t/y). This depends on the substance and the selected lab. This cost will be divided among the SIEF members. It is possible to reduce the cost using the read-across, QSAR method.
As a lead registrant, you have significant influence on the costs. You must make your calculations so being a lead registrant does not result in financial loss!
What are the specific costs after all?
- The costs of the toxicological tests proportionally divided among the SIEF members Toxicological costs must be divided in a fair, transparent, non-discriminative manner among the SIEF members. Of course the lead registrant can charge the other SIEF members for the costs of its added work.
- If there is a consortium, the costs of the consortium
- Expenditures paid to the REACH consultants
- Expenditures paid to the European Chemical Agency
Fees payable to the European Chemical Agency, ECHA, in Euro:
Size of Enterprise | Fee for substances in the range of 1-10 tonnes | Fee for substances in the range of 10-100 tonnes | Fee for substances in the range of 100-1000 tonnes | Fee for substances above 1000 tonnes | Fee for intermediates |
Large enterprise | |||||
joint submission | 1304 | 3506 | 9376 | 25274 | 1304 |
Medium enterprise | |||||
joint submission | 848 | 2279 | 6094 | 16428 | 848 |
Small enterprise | |||||
joint submission | 457 | 1227 | 3282 | 8846 | 457 |
Micro enterprise | |||||
joint submission | 64 | 173 | 462 | 1264 | 65 |
If you decide to be a lead registrant and you need a REACH consultant, I can offer the following services:
- Regular communication with pre-SIEF members in the required webpage of the SIEF
- Clarifying and arranging analytical examinations in order to identify the substance, the additives and impurities, communicating about the sameness of the substance with the pre-SIEF members, as necessary
- Identifying “dormant” registrants
- Regular communication with active SIEF members
- If the SIEF members have toxicological data available, checking them according to the Klimisch score and making recommendation for which one should be used for the dossier
- If the client has toxicological data available, checking them according to Klimisch-score
- Doing the literature research from current data bases in order to reduce the number of tests
- Checking read-across and QSAR methods with a qualified toxicologist in order to reduce the number of tests
- Buying toxicological tests from data holders if possible
- Preparing the list of and arranging the toxicological tests required in a GLP laboratory (Annex IX and X require a testing proposal by 2010 and not a full test)
- Calculating the individual fees which should be paid to the lead-registrant by SIEF members
- Arranging the payment to the European Chemical Agency (ECHA)
- Preparing the “full” registration dossier in IUCLID 5 program
- Submitting the “full” registration dossier through REACH-IT to ECHA
- Making the “token” number available for SIEF members who paid the fee
- Of course the specific services which your company needs must be discussed in person, since selecting the appropriate REACH consultant is a big responsibility!
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
REACH audit
REACH is a European Union regulation regarding chemical substances. It is to be followed in each EU member country directly. As described in the regulation, all members of the industry, including chemical substance producers, importers and downstream users, but also producers whose end products contain chemical substance, must comply with REACH.
Authorities perform regular checks at producers and importers of chemical substances to ensure compliance with REACH regulation. Penalties for non-compliance range from 370 Euro up to 74 000 Euro in Hungary.
Your company probably doesn’t want to receive a penalty, does it?
At your request I can visit your company, assess through a detailed audit what parts of the regulation apply to you, and then help answer all your questions during the registration process. At the end of the consulting I provide you with a written summary of the tasks your company must perform related to REACH. The on-site consultation takes appr. 4-5 hours. Following the audit, I also provide a one hour telephone consultation to answer any questions you may have regarding the summarized tasks.
We recommend REACH audit for you in the cases, if
- You theoretically know your REACH related tasks but need help in their completion for the registration
- You understand everything but lack the time or a confident knowledge of the English language to represent your company’s interests in the SIEF (Substance Information Exchange Forum)
- You receive several questions regarding REACH from your buyers, and have no idea how to answer them
- You produce or import chemical substances so you tried to understand REACH, yet you are still unclear about what specific tasks your company has after the pre-registration
- You have no intention to read and understand the 800 page long REACH regulation and the related English language instructions
- You are unsure which chemical substances are limited according to REACH and which ones receive exemption
- You have chemical substances which are critical for production, for which you have not found the EINECS number on the safety form, and you are also not sure what to do with these substances after 1 Dec 2008
- You cannot decide whether the substance, which you believed was polimer for years, is really regarded as polimer according to REACH
- Or simply if you want to know the essence of this regulation, as in the next ten years this regulation will be an important factor in the everyday life of the environmental, health and safety collegues of the company
You do not need the REACH Audit, if
- Your company does not currently use and doesn’t plan to use in the future any chemical substance, or if
- You are clear about the tasks related to REACH which apply to your company
If you cannot decide if you are impacted by REACH, feel free to call me at the +36-20-220-5737 number, and I can help you make a decision in a short telephone consultation.
100% money back guarantee for your satisfaction
If for any reason you are not satisfied with my work or my attitude, or maybe you think that REACH audit did not help you in any way, I will return the full consulting fee to you within two weeks following the consultation.
If you have decided that you would like to review in a REACH audit what applies to you from the regulation, then don’t delay further, ask a quotation! Within 2 days I get in contact with you and we can agree about the location and the timing of the consultation.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
IUCLID 5 training
I have completed the IUCLID training in January 2009 at the REACH Centrum in Brussels. Since then I have prepared several dossiers.
If you need IUCLID training at your company, or you have difficulties preparing the registration dossier, I am glad to help you.
Training includes
- Installation of IUCLID
- IUCLID website
- Transfer REACH-IT data into IUCLID
- Set up users and legal entity
- Roles, special rights
- Reference substances
- Session tree filling
- Mini Dossier creation in IUCLID
- Dossier checking tool
- Mini Dossier submission in REACH-IT
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
REACH CD
If for some reason you need to understand the basics of REACH regulation now, you can find the necessary information summarized on the CD “What the industry participants need to know about the REACH regulation” prepared by me.
When ordering the CD, you can receive a free one hour telephone consultation as a bonus, in which we can discuss the questions that came up while you were listening to the CD. The CD is in Hungarian language, so for non-Hungarian speakers I recommend a REACH consultancy service instead of the CD. We can do the REACH consultancy through skype or personally.
Price of REACH CD: 12 000 HUF
What is REACH?
For many companies, REACH means nothing more than added work, increased expenses and doubts at the same time. My consultancy offers guidance and support for companies in a successful implementation of this new European Union chemical legislation.
REACH is Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into effect on 1 June 2007.
REACH requires active participation from all members of the industry in order to achieve regulatory compliance.
This EU Regulation requires that all substances manufactured within or imported into the EU as stand alone or part of a more complex preparation, or article which exceed 1 ton / year in quantity by manufacturer or importer, must be pre-registered and registered within very specific and strict time-frames. Only substances which have been pre-registered between June1, 2008 and November 30, 2008 can be manufactured or imported after June 1 2008. Furthermore, only substances which have been registered by Dec 2010, June 2013 or June 2018, depending on the volume manufactured or imported, can continue to be further manufactured or imported.
The outcome of the registration inspections will define whether these substances are considered safe or if any restrictions, substitutions or bans must be implemented for purposes of safety. The safety information on substances must be provided through the entire supply chain to allow all users to safely handle chemicals.
Only representative of NON-EU companies
If you are a non-EU company and you hear about REACH regulation for the first time, you must know that one of the main objectives of the REACH regulation is to protect the EU industries and its citizens, and only allow non-EU chemical substance producers into the EU market.
The EU company, which buys from a non-EU partner, takes the responsibility to have the tests performed, which are required by REACH, for the chemical substances produced outside the EU.
It is very important that a company, which imports a chemical substance into the EU market, must take the same responsibility for that chemical substance as if it had been produced by the company itself. Therefore you, as a non-EU company, must make sure to provide ample information to your EU partner, otherwise they are unable to comply with the regulations and can expect serious penalties. In each member state of the EU the compliance with the REACH regulation is verified, but fortunately it is understood in the same way everywhere so you don’t need to worry that it may be stricter in one member country than in the other.
Following the registration deadlines (2010, 2013, 2018), it will be the interest of EU chemical substance users or importers, if they don’t want to pay for REACH registration, to buy either from EU producers or those non-EU producers who have appointed an EU only representative.
How non-EU companies can compete with their EU counterparts?
If you have monopoly in the market, and know that EU companies can only buy a particular chemical substance from your company, then you can easily ignore the REACH regulation. The EU company, which is unable to buy from anywhere else and needs your chemical substance, will pay their share of the REACH registration.
If you have no monopoly in the market where others can buy your chemical substance elsewhere, yet you do not want to suffer from competition, it is worth appointing an EU only representative. This of course means increased expenditures as, similar to EU companies, you will also have to pay your share of the REACH registration. In return, however, you will be able to compete in the EU market with equal chances.
More and more EU companies choose the strategy of only trading with their non-EU partners if they appoint an only representative.
My company is currently an only representative for several non-EU chemical substance producers, therefore if you need any advice regarding this issue, don’t hesitate to ask!
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
Pre-registration is possible after 1 Dec 2008 until 1 June 2017
I would like to manufacture or import a chemical substance, which has not yet been pre-registered, what should I do?
The first obligation of a manufacturer or importer of substances is pre-registration. Substances manufactured or imported at a quantity of more than 1 metric ton per year had to be pre-registered by 30th of November 2008. Only pre-registered substances are allowed to stay on the market without registration until the end of the registration period for their volume band (2010, 2013, 2018). Substances that have not been pre-registered are treated as new chemicals, and these are not allowed on the market without full registration.
If your company starts manufacturing or importing, for the first time, chemical substances at a quantity of 1 ton or more per year after 1 December 2008, you can benefit from late pre-registration provisions. The first-time manufacturer / importer (see Article 28.6) must pre-register at the latest six months after its produce or import exceeds the one-ton treshold, and at least 12 months before the relevant deadline for registration. First-time manufactureres and importers will therefore have to submit their pre-registration before 30 November 2009, 31 May 2012 or 31 May 2017, whichever is relevant in view of their tonnage thresholds. Manufacturing or importing for the first time means, the first time since the REACH regulation entered into force on 1 June 2007.
Pre-registration service includes:
- I double-check the information provided and gather any missing detail as neccessary
- I then complete the pre-registration
I forgot to pre-register a substance which we manufactured/imported at a quantity over 1 ton in 2008. What should I do?
If a manufacturer or importer has missed the pre-registration prior to 30 November 2008, or missed the deadlines from the beginning of the manufacturing or importing of the substance, it will not be able to take advantage of these intermediary periods and will need to suspend the manufacturing or importing of the substance until it receives the registration number from the European Chemical Agency (ECHA) in Finland.
There are further possibilities to resolve this kind of a situation, however the discussion of these must take place as part of a consultation.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
REACH notification
According to REACH requirements, a targeted analysis should only be conducted as a last resort in order to identify whether substances of very high concern are present in articles.
The Service includes:
- Conducting analyses to identify whether substances of very high concern are present in your articles
- Assistance in choosing the laboratory for article testing
- According to the laboratory report, determining if any high concern substance reach the 0.1 w/w % in your products
- Providing strategic advice in order to reduce the risks of substances of high concern in the article
- Preparing the dossier for notification of substances of high concern, as requested in 2011
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
Manufacturers of articles may have three important tasks
- Pre-Registration, Registration
Pre-registration or registration is only required if, among normal circumstances of using the article, a chemical substance can intentionally enter the environment, and this chemical substance is present in the given articles at quantities exceeding 1 ton per year. To illustrate this with an example, a scented eraser is an article where the chemical substance (perfume) enters the environment during the usage of the article. If this eraser is sold in a quantity that results in the possibility of 1 ton of perfumed chemical substance entering the environment per year, then the perfume substance must be registered.
If you are impacted by this section, please read the registration part of my website. - Notification requirement
Notification requirement and registration requirement are two different tasks. You have a notification requirement to the European Chemical Agency, if any candidate listed substance can be found in the given article at a quantity exceeding 1 ton, and at a weight concentration exceeding 0.1 percent. The first notification deadline is 1 June 2011. By this date the company should prepare an agenda of how it will test the presence of the candidate listed substances in its end products. I would like to emphasize that the 0.1 weight percentage is calculated for the entire article and not its components.
If you have a candidate listed chemical substance in your article, then your best choice is to replace this substance with a less hazardous chemical substance by latest 1 June 2011.
You can find the candidate list at the following link »
This work is not at all as simple as we would think, therefore it is useful to develop a good database. I can recommend companies with experience in developing REACH databases.
According to Article 7(6) a registration or notification of a substance in articles is not required, if the substance has already been registered for that use (i.e. the process by which the substance is included in the articles). This refers to any registration of that use of the substance in the same supply chain or any other supply chain. - Communication requirement
If any of the chemical substances in the given candidate list can be found in the article at a concentration exceeding 0.1 weight percentage (w/w), then the manufacturer /importer of the article must indicate in a statement for their supply chain in the next supply, and at the request of the consumers, that the article contains chemical substance included in the candidate list. The related information must be provided to the consumers free of charge, within 45 days of receiving the request.
Therefore the main objective is to exclude all chemical substances from the articles, which are found in the candidate list, in order to avoid having to comply with the additional requirements. I would like to raise your attention to the fact that the addition of further substances to the candidate list will depend on the results of the toxicological tests. It is expected that a new list will be issued every year.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
Tasks of intermediate producers
If your buyer produces from your chemical substance another chemical substance, then you have a good chance for the cheaper intermediate registration. According to REACH the intermediate does not need to remain within the premises in all cases, it is quite possible that your end product is an intermediate according to REACH.
The intermediate registration is significantly cheaper than a normal chemical substance registration.
It may be important to discuss whether it is possible to treat the substances as transported isolated intermediates.
During a transported isolated intemediate registration the manufacturer or importer confirms that he is manufacturing and/or using the substance under strictly controlled conditions and he confirms himself or states that he has received confirmation from the users that the substance is used under strictly controlled conditions.
Registering both as intermediate and normal substance only makes sense, if registering as intermediate reduces the quantity of all the substances to be registered in a way that they fall in a lower registration limit-category. Registering as intermediate only can be significantly cheaper both from the point of view of the registration fee and the amounts payable to the lead registrant.
REACH instructions provide a very precise definition for strictly controlled conditions.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
Preparing Safety Data Sheets in compliance with REACH regulation
Safety Data Sheet (SDS) service includes:
- Checking the validity and usability of the current safety data sheet
- Preparing new or updated safety data sheet
- If possible, preparing GHS classification
- Translating the safety data sheet into other languages
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.
Safety Data Sheets as required by REACH
It is a well-known requirement that suppliers of hazardous substances and preparations provide a Safety Data Sheet to the recipients at the first supply. REACH details the requirements of a safety data sheet in Article 31 and 2015/830/EU regulation.
Safety Data Sheets must be prepared for persistent, bioaccumulative and toxic, the so called PBT-substances, for very persistent, very bio-accumulative, the so called vPvB-substances and for a dangerous substances and dangerous preparations.
If there is an orange colored hazard symbol at sections 2 of the safety data sheet, then the substance or preparation is qualified as dangerous /hazardous. Therefore, while from the point of view of pre-registration or registration it didn’t matter if the substance was categorized dangerous, for the safety data sheet this must be indicated. In my experience suppliers provide safety data sheets even for chemical substances and preparations categorized as non-dangerous, thus making the work of environmental health and safety colleagues easier. REACH accepts the indication of non-dangerous chemical substance using different ways of communication, not only through the use of safety data sheet.
It is required to prepare a safety data sheet according to the 2015/830/EU regulation for hazardous substances and mixtures from 1st of June 2015.
REACH requires that in section 1 of the safety datasheet the registration number must be indicated, but as we know most substances will only receive the registration number by 2010, 2013 or 2018. Until then producers and importers can only provide the pre-registration number.
From a local EU distributor you should only accept a safety data sheet written in local EU language. The REACH regulation allows that European Union suppliers provide safety data sheet in an official language of the EU Member States (Article 31.5). If possible, downstream users should not modify the safety data sheet provided by the supplier.
According to REACH, the use of a substance or preparation following the completion of the registration must be indicated in section 1.2 of the safety data sheet. Communication about this has already begun between producers and buyers. If the buyer receives such a questionnaire from the producer or importer, they must fill that in to the best of their knowledge and return it to the producer or importer. This is important because if the usage of the buyer is not indicated in the registration dossier, they may have problems with the usage of the substance later. REACH requires that if a buyer indicates their use of the substance 12 months prior to registration deadline of the producer or importer, the producer or importer is obligated to check this use during the registration. If the use means an acceptable level of hazard, they must include this among the identified uses. If, following the completion of the registration, the buyer cannot find its own usage on the safety data sheet refreshed by the producer, they must indicate the discrepancy to the producer and ask them to prepare the evaluation also for the buyer’s conditions. If the producer indicates that they do not recommend usage of the hazardous substance or preparation for the conditions given by the buyer, this must be indicated by both parties to the European Chemical Agency, and only after this can the producer transport the chemical substance to the buyers premises. In this case the buyer needs to prepare the chemical safety assessment if his use exceeds 1 ton /year.
Communication has begun within the supply chain about gathering a list of the uses. The most frequently used tool is that prepared by Cefic, called “use descriptor system”.
If the substance requires authorization or there is a restriction of its uses, information regarding this must be indicated on the safety data sheet. If the registration requires, the ‘exposure scenario’ must also be attached to the safety data sheets.
Safety data sheets must be retained for 10 years, or in the case of carcinogen substances for 40 years (this last one is not REACH requirement).
REACH requires that producers or importers or mixers of hazardous preparations must prepare a categorization of the hazard. Currently for hazardous substances and mixtures categorization should be made according to the new CLP (GHS) (1272/2008/EK) regulation in the 2nd and 3rd point of the SDS.
For hazardous mixtures the categorization should be made based on 1999/45/EC, “DPD” legislation, or according to the new CLP (GHS) (1272/2008/EK) regulation in the 2nd and 3rd point of the SDS.
For further information about the CLP (GHS) regulation, please refer to the GHS Basics .
Fundamental changes regarding the content of the Safety Data Sheets can only be expected with the introduction of the new global hazard symbols, and also after the registration dossiers have been completed. Based on these producers and importers will be able to attach the exposition schemes, as well as the usage and application information to the renewed Safety Data Sheets.
Requesting a price offer is free of charge, means no obligations for you and you will receive the offer in 2 days.