REACH REGISTRATION REQUIREMENTS FOR SUBSTANCE A, B, and C

MANUFACTURED OR IMPORTED

Prepared for:

Environmental Risk Assessment Management 3rd Assignment

Prof. Dr. Jan C. Bongaerts

By:

Santosh Mudvari: 57026

Xu Junjie- 57093

Athariq Pribadi- 56625

Evgenia Erogova- 55666

 Assume a company in the chemical sector. You have the following products:
1. A new substances A with quantity between 1 to 10 tons per annum
2. A new substances B with quantity between 10 to 100 tons per annum
3. A new Substances C with quantity more than 100 tons per annum
Describe the obligation of your company according to REACH with respect to:
Which duties of registration and information of ECHA and of downstream users?
Which information content must be provided?
Which deadlines must be taken into account?

I. Which Duties of registration and information of ECHA and of

downstream users?
Duties of registration and information of ECHA

Our Company will produce three new substances, which are new substance A with the quantity 1
to 10 tonness per annum, B with the quantity 10 to 100 tonnes per annum, and C with the
quantity more than 100 tonnes per annum. Since all of the new substances of our products have
the quantity above 1 ton per annum, as manufactures of new substance, our company has
obligation to inform and register all of them to ECHA. The register of new substances should
follow one substance, one registration principle. Furthermore, our company should collect
all the information, such as consists of hazard information, an assessment of the risk, and knows
to control the risk from the substances for each new substance and will compare with the
standard information.
a. Inquiry dossier
The inquiry dossier is a first step of our company should prepare to register each of our new
substances (A, B, C) that our company produces. The inquiry dossier should contain the
information:
The identity and role of the company as a producer of the new substances
The composition of the new substances that want to register
The annual quantity in tonnage for each substance that want to produce
Name of the substances
All the new information from the new studies for each substances
Afterwards, Our Company has to wait the response from EACH and can continue to the next
steps, prepare the registration dossier.

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 b. The registration dossier
The registration dossier is also for all the new substances (A, B, C). The figure 1 shows the steps
of registration procedures for the new substances to ECHA.

Figure 1.Steps within the registration process

1. Registration dossier of new substances A

The registration dossier composed of technical dossier, and chemical safety report (CSR).
However, the new substance A does not need the CSR, while the CSR needed if our new
substance has amount of 10 tonnes or more a year,which mean for the new substances B and C.

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 2. Registration dossier of new substances B and C

The registration dossier for both substances composed of technical dossier, and chemical safety
report (CSR) because the quantity of both new substances have amount more than 10 tonnes a
year.

The content of CSR for both new substances are must hold a particular comprehensive summary
of information about hazardousness of the substances, which effects on environment and human
health. Moreover, the assessment of exposure and risk must provide in the report. It helps to
describe the conditions of substances use, such as operational conditions (temperature and risk
management measures) under which the risks can be operated.

Table 1. Summaries of the submission of each new substance for registration

Requirement New Substances A New Substances B New Substances C
Technical dossier submission Yes Yes Yes
Chemical safety report (CSR) / No Yes Yes
assessment submission

Once all essential information for all the new substances A, B, and C, has been collected and the
registration dossier on the substance completed (using the IUCLID 5 software), it must be
submitted to ECHA through REACH-IT tools in accordance with the deadlines. Submit a
registration dossier for each substance individually and separately in order for them to be
processed and registered. Pay the registration fee for the substances A, B and C.

Duties of Information of downstream user

Our company also has to provide the information on chemical safety data sheets to ensure the
safe of each new substance to downstream users. The chemical safety data sheets are parts of the
information, required to be provided by manufacturer at registration under REACH. Appropriate
information provided to downstream user includes:

1. Classification of new substances A, B, and C (hazardous or non-hazardous)

2. Identified uses of new substances A, B, and C

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 3. Hazard assessment of all new substances
4. Exposure level for substance (A, B, and C) above which human should not be exposed
with frequency and duration of exposure and route of exposure as well
5. Risk characterization for each substance (A,B, and C) and information about risk
management
6. Predicted no effect concentration for environment

II. Which information content must be provided?

The information content should be included in registration dossier. The information of the
technical dossiers of new substances A consist of the available information on substances
proper immanent features (identity, classification, labeling) and gathering the existing
information on the substance properties (physicochemical, toxicological, and ecotoxicological)
based on the ANNEX VII of REACH
The technical dossiers of new substances B consist of the available information on substances
proper immanent features (identity, classification, labeling) and gathering the existing
information on the substance properties (Toxicological and Ecotoxicological) based on the
ANNEX VIII of REACH.
Meanwhile the new substances C consist of the available information on substances proper
immanent features (identity, classification, labeling) and gathering the existing information on
the substance properties (physicochemical, toxicological and ecotoxicological) based on the
ANNEX IX of REACH.
Figure 2 below shows the overall process related to information requirements and chemicals
safety assessment for the new substances B and C under REACH.

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Figure 2. Overall process related to information requirements and chemicals safety assessment

III. Deadline of Registration New Substances

Our company are producing new substances (non-phases) of A, B, and C with different amount
of tones. For non-phase-in substances which are manufactured in a present case the registration
procedure must be accomplished before the manufacturing or import of the substance into EU.

As soon as there is no information upon the registration procedures duration the exact time of
beginning registration prior to manufacturing cannot be specified, but should be made at least
180 days prior to manufacturing.

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References
1. ECHA. (2012). Guidance on registration. In Guidance (2.0 ed., Vol. 126, pp. 55-
57, 67-68). ECHA. Retrieved from
http://echa.europa.eu/documents/10162/13632/registration_en.pdf
2. ECHA , (2013). Guidance for downstream users. In Guidance (2.0 ed., pp. 27).
ECHA. Retrieved fromhttp://echa.europa.eu/guidance-documents/guidance-on-
reach
3. ECHA,(2014). Official web site:
http://echa.europa.eu/web/guest/regulations/reach/downstream-
users/downstream-user-roles-and-obligations
4. Milieu,ARCHE, RPA. (2012). Review of REACH Registration Requirements for
Substances Manufactured or Imported between 1 to 10 tonnes. Norwich:
European Commission, DG Emission.