1. REACH 2018
Know your portfolio and start preparing now

2. Purpose of this presentation
This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about REACH 2018, i.e. the last registration deadline of phase-in substances. The intention is that you can select relevant slides and modify them to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission.
This presentation gives a brief overview of phase 1 (Know your portfolio) of ECHA’s REACH 2018 Roadmap. It belongs to a series of presentations relating to REACH 2018, which are on ECHA’s website. We welcome your comments and suggestions at:
Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document.
Release: May 2017

3. Registration is your responsibility
You are responsible for safe manufacture and use
Collect and generate data on properties and uses of your substances
Assess risks
Develop measures to manage the risks
Communicate them down your supply chain
 Document it in your registration dossier
Registration is your opportunity to document your responsibility for the safe manufacture and use of your substances by going through the steps in this slide. Your registration dossier sent to ECHA is the proof that you meet your responsibilities.

4. REACH registration 2018 Phase 1 activities: Know your portfolio
Identify your substances
Determine your registration obligations
Understand your information needs
Consider the business impact
ECHA’s REACH 2018 Roadmap splits successful registration into 7 phases
In this presentation, activities for phase 1 are covered. They consist of the start-up activities you will do before you start working with other co-registrants.
For more detailed support material, go to:

5. Know your portfolio Express your portfolio in terms of substances
substances on their own
mixtures: which substances are in them?
articles: which substances are released from them?
 Register substance C
The starting point for preparing to register is to know your portfolio in REACH terms; which substances you are dealing with.
In some cases, this can be straightforward. For example, if you are manufacturing substances or importing substances on their own, you probably have your substance inventory already.
If you are dealing with products (mixtures), like detergents or paints, you need to know or find out which substances they are made of, because it is the substances that you need to register, and not the products.
So, substances on their own need to be registered, substances in mixtures, and also substances in articles that are meant to be released from the article, for example, a fragrance substance that is released from T-shirts.
 Register substances A and B

6. Identify your substances
Determine the composition and type of substance:
mono-constituent
multi-constituent
UVCB
Determine the name and identifiers (EC number and CAS number)
For each of the substances in your portfolio, you need to characterise and identify the substance according to the rules set in REACH.
This means that you normally need to have a set of chemical analyses done, and based on that, with a chemist, determine the composition and type of substance, and in particular whether the substance is:
a mono-constituent substance, consisting mostly of one constituent
a multi-constituent substance, consisting of more than one constituent or compound or
a UVCB, which is a substance of unknown or variable composition, a complex reaction product or a biological material.
Based on the composition and type of substance, you need to determine the name of the substance and then find the EC and CAS number (if available for your substance). Or check that the EC and CAS number you are using fits with the name and identity of the substance as it appears from the chemical analyses.
It is important to identify your substance correctly because later on you will need to discuss with your co-registrants if you have the same substance. If you have the same substance, you will need to register jointly and ensure that the data in the joint registration is suitable for all the co-registrants.
Useful links:
Guidance on identification and naming of substances under REACH & CLP (
Substance identification (

7. Identify your substance (2)
Here the spectra of monoconstituent, multiconstituent and UVCB substances are presented schematically.
Monoconstituent substance has one main constituent of >= 80 %
Multiconstituent has two or more main constituents in concentrations between 10 and 80 %
UVCB substance constituents vary or cannot be exactly identified. The source material and manufacturing process are typically used to identify UVCB substances.
Monoconstituent substance
Multiconstituent substance
UVCB substance

8. Determine your registration obligations
YES
YES
YES
Once you know which substances are in your portfolio, you can determine your registration obligations for each of them.
To do this, there are three questions to ask and if the answer is yes to all three questions you will have to register the substance.
If the answer if no to one of these questions, you don’t have to register the substance. They are:
Are you a manufacturer, importer or an only representative for the substance?
Does the substance need to be registered?
Is your annual volume for the substance at or above one tonne?
In looking at these three factors, you should start with the one that is most likely to give you a no rather than a yes.
You need to register this substance!

9. Role in the supply chain
Do you need to register the substance?
Determine if you are:
A manufacturer
An importer into the EEA
An only representative
A producer or importer of an article from which a substance is released
The first question is about your role in the supply chain, and it is ‘Do you need to register the substance?’
First, it is important where you are located. If you are located in any of the countries in the European Economic Area, you may have to register. Those countries are shown on the map here in dark blue. We are talking about the EU Member States plus Norway, Iceland and Liechtenstein. If you are located in any of the countries in light blue outside the European Economic Area you cannot register.
Secondly, you have to determine what exactly it is you do with the substance. There are four supply chain roles that need to register.

10. Scope and exemptions Does the substance need to be registered?
Check exemptions from registration for:
substances (polymer, water, …)
uses of substances (product development, food, …)
specific conditions (re-import, waste, …)
Some substances do not need to be registered, mostly because they are known to be low risk. Note: For polymers, check the criteria for what is a polymer carefully, and if the substance is a polymer then you need to register the monomers instead.
There are also uses of substances that are exempted, because they are adequately regulated under other legislation or other provisions under REACH. If you use the substance only for the exempted use, you would not need to register, but if you or your customers have other uses for the substance, then you would need to register.
A third category of exempted substances relates to specific conditions, such as re-imported substances that have already been registered, substances discarded as waste, or substances recovered from waste that have already been registered.

11. Volume Do you reach the 1 tonne per year threshold?
Calculate your volume for each calendar year:
if you manufactured or imported during the last three years, use average of the last three years
if not, use the volume manufactured or imported in a calendar year
Highest tonnage per year calculated as above since 1 June 2007 determines your registration deadline
Tonnage per year as calculated on the year of registration determines your information requirements
if you manufactured or imported during the last 3 years, use the last 3 years average
if not, use the estimated volume manufactured or imported in the calendar year of registration
Separate calculation for intermediates under strictly controlled conditions
Then the third factor to consider next to your role and the substance itself is your volume, and the question to ask is ‘Do you reach the 1 tonne per year threshold’?
Your volume will also determine how much information you will need to provide in your registration, so you should also determine if you are between 1 and 10 tonnes per year, between 10 and 100, between 100 and 1000 or above 1000.
Both the tonnage determining the registration deadline and the tonnage determining information requirements are calculated as three year average, if the condition of three consecutive years is fulfilled.
If you use the substance also as an intermediate in the production of another substance, under strictly controlled conditions, you can normally make separate volume calculations for this. The information you will need to provide in for registration for intermediate is less than for a full registration.
Useful links:
Guidance on Registration, sections and 2.3 (

12. What information you need?
Identification of your substance
Analytical information
Information on manufacture, use and exposure
All uses in the life-cycle, from manufacture to waste
Physico-chemical information such as
Boiling point, vapour pressure, granulometry …
Classification and labelling
Always needed
The following three slides give a flavour of the information you need to collect or generate for your registration.
In general, you need to collect all physico-chemical, toxicological and ecotoxicological information that is relevant and available. But the REACH Regulation sets a minimum of information to be provided. This minimum is presented here in a very schematic form.
If your tonnage is between 1-10 tonnes a year and you can justify that your substance is a low risk substance (it does not meet Annex III criteria), this is the minimum information required.
Useful links:

13. Information you need Toxicological information such as
Skin and eye irritation – in vitro
Mutagenicity in bacteria – in vitro …
Eco-toxicological information such as
Short-term aquatic toxicity on Daphnia
Biodegradability
1 to 10 tonnes/year
These, together with the requirements in the previous slide, are the standard information requirements for a registration of a substance that are not of low risk - in quantities between 1-10 tonnes a year.
In this slide, a few examples of such studies are given. For a full list, see Annex VII to REACH.
Further information:

14. Information you need Toxicological information such as
Short-term repeated dose toxicity
Screening for reproductive toxicity …
Eco-toxicological information such as
Short-term aquatic toxicity on fish
Activated sludge respiration inhibition
Adsorption/desorption screening
Chemical safety assessment!
10 to 100 tonnes/year
These, together with the requirements in the two previous slide, are the standard information requirements for a registration of a substance in quantities between tonnes a year.
Some additional studies are needed for both toxicological and eco-toxicological properties. A few examples of such studies are given in this slide. For a full list, see Annex VIII to REACH.
Importantly, at this tonnage level a full chemical safety assessment needs to be conducted. It has to be documented in a chemical safety report included in the registration.

15. Information requirements for registration of intermediates
Reduced requirements apply if you manufacture isolated intermediates under strictly controlled conditions
Intermediate definition
substance is transformed into another substance and manufactured
used under strictly controlled conditions at chemical manufacturing sites
The status of a substance as an intermediate is not specific to its chemical nature but to how it is used after manufacture.
Further information:
Guidance on Intermediates (

16. Before you generate new data
Collect available information
Share data with other companies
Information will need to be submitted jointly
Consider information needs
Identify information gaps
There is an obligation to collect all available, existing information, even if this is more than the minimum requirements set in REACH for the registration.
Registrants need to share the information with other companies registering the same substance. All the information on the properties of the substance needs to be submitted jointly by all the companies dealing with the same substance (one substance, one registration principle of REACH).
Once there is a good overview of all the information at hand, the registrants as a group need to compare the existing data with the information required for registration.

17. What you need to consider for your business
Compiling and assessing information…
within your company
What information do you already have on the substance?
Do you know how the substance is used?
Do you have the expertise to complete registration?
with your co-registrants
Are there other companies or are you on your own?
Agreeing on how to work together
Assessing and sharing existing information
Generating missing information
Registering a substance will require investing on compiling and assessing information.
This activity will need to take place at two different levels: within each registrant’s own company, and with other companies manufacturing or importing the same substance.
This means investing resources on:
collecting and evaluating all available information within own company, including literature searches.
obtaining information on the different uses of the substance by customers and down the supply chain.
Consider whether there are the required experts within the organisation, or whether the task should be outsourced.
With other companies registering the same substance, contractual arrangements are needed to work together and agree how to generate any missing information and share the costs.

18. What you need to consider for your business
Internal organisation
Plan registration of all your substances in time
Involve other departments: financial, sales, drafting safety data sheets
Get to know the IT tools: IUCLID, ECHA Cloud services and REACH-IT
Enhanced versions published in 2016
Keep resources for updating your registration over time
Experience from companies which have already registered their substances shows that good planning is essential to meet the deadline.
Consider involving early enough other departments within the company which will certainly have a role to play.
Depending on the number of substances you need to register by 2018, it might be useful to prioritise one of them to go from start-to-end now to learn how the whole process works.
It is also useful to get to know the IT tools for registration.
Finally, the information considering the substance will evolve with time, and it needs to be kept up-to-date in the registration. A certain level of resources for this should be foreseen.

19. Take away messages
You are responsible for the safe use of your substances – registration is an opportunity to document it
Go through your portfolio and start gathering all the information now
Determine which substances you handle
Plan now to have your chemical analyses done
How your customers use your substances
Registration takes time and resources
Available expertise in-house?
Support is available at