Guidance on registration of intermediates

  -----------------------------------------------------------------------
  ***This is a working document and can not in any circumstances be
  regarded as an official position of the Commission.***

  -----------------------------------------------------------------------

CONTENTS

[1 Introduction 2](#introduction)

[1.1 Definition of the different categories of intermediates
2](#definition-of-the-different-categories-of-intermediates)

[1.2 Tasks and obligations 3](#tasks-and-obligations)

[1.2.1 Non isolated intermediates 3](#non-isolated-intermediates)

[1.2.2 On-site isolated intermediates
3](#on-site-isolated-intermediates)

[1.2.3 Transported isolated intermediates
4](#transported-isolated-intermediates)

[2 registration of isolated intermediates
6](#registration-of-isolated-intermediates)

[2.1 Strictly controlled conditions 7](#strictly-controlled-conditions)

[2.1.1 Rigorous containment of the substance
10](#rigorous-containment-of-the-substance)

[2.1.2 Procedural and control technologies to minimise emission and any
resulting exposure
12](#procedural-and-control-technologies-to-minimise-emission-and-any-resulting-exposure)

[2.1.3 Handling of the substance by trained personnel
13](#handling-of-the-substance-by-trained-personnel)

[2.1.4 Cases of accident and where waste is generated
13](#cases-of-accident-and-where-waste-is-generated)

[2.1.5 Management System 13](#management-system)

[2.2 Registration requirements for on-site isolated intermediates.
14](#registration-requirements-for-on-site-isolated-intermediates.)

[2.3 Registration requirements for transported isolated intermediates
15](#registration-requirements-for-transported-isolated-intermediates)

[2.4 Preparation of a registration dossier for isolated intermediates
16](#preparation-of-a-registration-dossier-for-isolated-intermediates)

[2.5 Joint submission of data on isolated intermediates by multiple
registrants.
16](#joint-submission-of-data-on-isolated-intermediates-by-multiple-registrants.)

[2.6 Time lines 17](#time-lines)

[2.7 Registration fee 17](#registration-fee)

[APPENDIX 1: illustrative List of issues That may be taken into
consideration for checking that the isolated intermediates are
manufactured under strictly controlled conditions
18](#appendix-1-illustrative-list-of-issues-that-may-be-taken-into-consideration-for-checking-that-the-isolated-intermediates-are-manufactured-under-strictly-controlled-conditions)

[APPENDIX 2: Example of format for documenting in-house information on
strictly controlled conditions of isolated intermediates
20](#appendix-2-example-of-format-for-documenting-in-house-information-on-strictly-controlled-conditions-of-isolated-intermediates)

# Introduction

## Definition of the different categories of intermediates

REACH defines an **intermediate** as a *substance that is manufactured
for and consumed in or used for chemical processing in order to be
transformed into another substance(s)* (Article 3 (15)). Therefore
intermediates should not be present in the final manufactured substance
(except possibly as an impurity).

Different types of intermediates are defined under REACH:

-   Non-isolated intermediates

-   Isolated intermediates

```{=html}
<!-- -->
```
-   On-site (non transported) isolated intermediates

-   Transported isolated intermediates

**A non-isolated intermediate** is an *intermediate that during
synthesis is not intentionally removed (except for sampling) from the
equipment in which the synthesis takes place. Such equipment includes
the reaction vessel, its ancillary equipment, and any equipment through
which the substance(s) pass(es) during a continuous flow or batch
process as well as the pipework for transfer from one vessel to another
for the purpose of the next reaction step, but it excludes tanks or
other vessels in which the substance(s) are stored after the
manufacture* (*Article 3 (15)(a)*)*.*

**On-site isolated intermediate** means *an intermediate not meeting the
criteria of a non-isolated intermediate and where the manufacture of the
intermediate and the synthesis of (an)other substance(s) from that
intermediate take place on the same site, operated by one or more legal
entities (Article 3 (15)(b)).*

**A site** means *a single location, in which, if there is more than one
manufacturer of (a) substance(s), certain infrastructure and facilities
are shared (Article 3(16)).*

**A transported isolated intermediate** is *an intermediate not meeting
the criteria of a non-isolated intermediate and transported between or
supplied to other sites (Article 3 (15)(c)).*

Depending on the identified intermediates different obligations and
information requirements apply.

The lifecycle of an isolated intermediate begins with its manufacture
(in practical terms, with its removal from the manufacturing process).
This lifecycle ends with the use of the substance in the synthesis
process for the manufacture of another substance.

Residues of the isolated intermediate, which are not transformed into
another substance in a manufacturing process, will be typically
discarded or disposed of as waste and channelled into waste management
when not recycled as a non-isolated or isolated intermediate.
Consequently, they no longer fall in the scope of REACH. Where residues
of the intermediate are found in the synthesised substance, they are
covered -- as an impurity - by the registration and evaluation of that
other substance.

## Tasks and obligations

### Non isolated intermediates

For the use of a substance as a non-isolated intermediate, there are no
obligations under REACH *(Article 2(1)(c)).*

### On-site isolated intermediates

A manufacturer of on-site isolated intermediates in quantities of 1
tonne or more per year needs to register his substances. The information
to be submitted for general registration purposes (other than
registration as an intermediate) is listed under *Article 10* and
detailed in section 1.8.1 of the [Guidance on registration]{.mark}.
However registrants of on-site isolated intermediates can provide
reduced registration information according to *Article 17(2)* if they
confirm that the substance is manufactured and used under strictly
controlled conditions as described under *Article 17(3)* and section
2.1of this guidance.

**Registration obligations and exemptions**

-   *Article 2 (8)* exempts intermediates from the general obligation to
    register substances. Instead a manufacturer of an on-site isolated
    intermediate has to register his substance in quantities of 1 tonne
    or more per year under a different regime, as specified in chapter 3
    of Title II of REACH.

-   If the manufacturer confirms that the on-site isolated intermediate
    is manufactured and used under strictly controlled conditions (2.1),
    the information requirements on the substance intrinsic properties
    (physicochemical, human health and environment properties) are
    reduced to already available data and only study summaries have to
    be submitted if a full study report is available (*Article 17*) (see
    2.2).

-   If strictly controlled conditions are not met, a full (standard)
    data package is required depending on the tonnage level (*Articles
    10 & 12*).

-   In cases when an on-site isolated intermediate is a monomer used for
    polymerisation, the reduced registration provisions for
    intermediates do not apply to the substance and the manufacturer has
    to proceed as for a \"standard\" substance (see Guidance on
    registration).

-   If a notification under Directive 67/548/EEC covering the relevant
    use has already been submitted by the manufacturer/importer, no
    registration is required (*Article 24*); the substance will be
    considered as registered and a registration number will be assigned
    by the Agency (*Article 24*).

**Classification and labelling**

If the on-site isolated intermediate is a phase-in substance to be
registered the manufacturer must notify to the Agency the information
related to its classification and labelling if (*Article 113)*:

-   he puts the substance on the market (i.e. he makes it available to
    another legal entity on the same site), and

-   he has not already submitted a registration.

This has to be done before 1^st^ December 2010 for substances already on
the market at that date or, for substances that were not yet on the
market on 1st December 2010, as soon as the substance is put on the
market (*Article 116)*.

For on-site isolated intermediates registered before 1^st^ December 2010
the classification and labelling will be reported in the registration
dossier so that no separate notification is required.

If the on-site isolated intermediate is a phase-in substance
manufactured at less than one tonne per year, the manufacturer must
notify to the Agency the information related to its the information
related to its classification and labelling if (*Article 113)*:

-   he puts the substance on the market (i.e. he makes it available to
    another legal entity on the same site), and

-   the substance meets the criteria for classification as dangerous

This has to be done before 1^st^ December 2010 for substances already on
the market at that date or, for substances that were not yet on the
market on 1st December 2010, as soon as the substance is put on the
market (*Article 116).*

For non phase-in substances manufactured at 1 tonne or more per year a
registration dossier has to be submitted in any case including the
classification and labelling; in that case a notification is not
necessary.

**Dossier and substance evaluation**

-   For on-site isolated intermediates, dossier and substance evaluation
    do not apply. However the Member State Competent Authority (MSCA)
    where the manufacturing site is located may request additional
    information when it considers that:

-   there is a risk to human health or the environment equivalent to the
    level of concern arising from the use of a substance of very high
    concern (as defined in *Article 57*) and

-   that risk is not properly controlled (*Article 49*).

**Authorisation/Restriction**

-   Intermediates are not subject to authorisation (i.e. Title VII --
    Authorisation - does not apply). This is also valid for
    intermediates used as monomers for the synthesis of polymers.

-   Any manufacturer or downstream user must check whether an
    intermediate is covered by any restriction in Annex XVII of REACH
    (*Article 67*).

### Transported isolated intermediates

A manufacturer or importer of transported isolated intermediates in
quantities of 1 tonne or more per year needs to register his substances.
The information to be submitted for general registration purposes (i.e.
not reduced requirements due to strictly control conditions in place) is
listed under *Article 10* and detailed in section 1.8.1 of the [Guidance
on registration]{.mark}. However, a registrant of transported isolated
intermediates can provide reduced registration information according to
*Article 18(2)* if he confirms or states that he has received
confirmation from the user that the substance is manufactured and used
under strictly controlled conditions as described under *Article 18(4)*
and section 2.1 of this guidance.

**Registration obligations and exemptions**

-   *Article 2 (8)* exempts intermediates from the general obligation to
    register substances. Instead, a manufacturer or importer of a
    transported isolated intermediate has to register his substance in
    quantities of 1 tonne or more per year under a different regime, as
    specified in chapter 3 of Title II of REACH.

-   If he confirms or states that he has received confirmation from the
    user that the substance is manufactured and used under strictly
    controlled conditions (section 2.1) and the annual quantity of
    substance is less than 1000 tonnes, the information requirements on
    the substance\'s intrinsic properties (physicochemical, human health
    and environment properties) are reduced to available data and only
    study summaries have to be submitted if a full study report is
    available (*Article 18*).

-   When manufactured and used under strictly controlled conditions and
    the annual quantity of substance is 1000 tonnes or more, the data
    requirements on the substance\'s intrinsic properties
    (physicochemical, human health and environment properties) are
    equivalent to those for a substance supplied at between 1 and 10
    tonnes per annum.

-   Where strictly controlled conditions are not met, a full (standard)
    data package is required depending on the tonnage level (*Articles
    10 & 12*).

-   If the transported isolated intermediate is a monomer used for
    polymerisation, the reduced registration provisions for
    intermediates do not apply to the substance and the manufacturer has
    to proceed as for a \"standard\" substance (see the Guidance on
    registration).

-   However, if a notification under Directive 67/548/EEC covering the
    relevant use has already been submitted by the
    manufacturer/importer, no registration is required (*Article 24*).
    The substance will be considered as registered and a registration
    number will be assigned by the Agency (*Article 24*).

**Classification and labelling**

If the transported isolated intermediate is a phase-in substance to be
registered the manufacturer, importer must notify to the Agency the
information related to its classification and labelling if (*Article
113)*:

-   he puts the substance on the market (i.e. he makes it available to
    another legal entity on the same site or on another site), and

-   he has not already submitted a registration.

This has to be done before 1^st^ December 2010 for substances already on
the market at that date or, for substances that were not yet on the
market on 1st December 2010, as soon as the substance is put on the
market (*Article 116)*.

For transported isolated intermediates registered before 1^st^ December
2010 the classification and labelling will be reported in the
registration dossier so that no separate notification is required.

If the transported isolated intermediate is a phase-in substance
manufactured at less than one tonne per year, the manufacturer must
notify to the Agency the information related to its the information
related to its classification and labelling if (*Article 113)*:

-   he puts the substance on the market (i.e. he makes it available to
    another legal entity on the same site or on another site), and

-   the substance meets the criteria for classification as dangerous

This has to be done before 1^st^ December 2010 for substances already on
the market at that date or, for substances that were not yet on the
market on 1st December 2010, as soon as the substance is put on the
market (*Article 116)*

For non phase-in substances manufactured at 1 tonne or more per year a
registration dossier has to be submitted in any case including the
classification and labelling; in that case a notification is not
necessary.

**Dossier and substance evaluation**

-   Manufacturer / importer must be aware that dossier and substance
    evaluation apply to transported isolated intermediates. Therefore,
    the Agency or, if there is no agreement between MSCA, the Commission
    may request additional information when it is conducting an
    evaluation. The manufacturer/importer must comply with any such
    request within the deadline set (see the Guidance on evaluation).

**Authorisation/Restriction**

-   Intermediates are not subject to authorisation (i.e. Title VII --
    Authorisation - does not apply). This is also valid for
    intermediates used as monomers for the synthesis of polymers.

-   Any manufacturer/importer or downstream user must check whether an
    intermediate is covered by any restriction in Annex XVII of REACH
    (*Article 67*).

# registration of isolated intermediates

This guidance is intended to support registrants to answer the question,
whether a registration according to *articles 17 or 18* can be provided
or a full registration is required for an intermediate.

Isolated intermediates (on-site as well as transported intermediates)
are within the scope of REACH although specific requirements apply for
their registration (*Articles 2(8), 17, 18, and 19*).

Manufacturers of on site isolated intermediates and manufacturers or
importers of transported isolated intermediates in quantities of 1 tonne
or more per year need to submit a registration dossier.

If the manufacturer or importer of a substance manufactures or imports
the substance for other purposes than only the use as an intermediate,
or if the manufacture or use(s) are not under strictly controlled
conditions, then the manufacturer or importer needs to submit a
"standard" registration dossier according to *Article 10*. The
information requirements for this registration dossier are based on the
tonnage for non intermediate uses and for intermediates not used under
strictly controlled conditions. If part of the tonnage manufactured or
imported is for uses as intermediate under strictly controlled
conditions, this tonnage will not need to be taken into account for the
information requirements of the registration dossier. Nevertheless the
use as intermediate should be documented in the dossier, including the
volume manufactured or imported for this purpose.

Example 1 Tonnage to consider for the registration dossier of a
substance both used as isolated intermediate and non-intermediate

A company manufactures 2300 tonnes of substance A, of which 1700 tonnes
are used as intermediate in strictly controlled conditions. This company
will submit a standard registration dossier for substance A, where the
volume of the remaining 600 tonnes not used as intermediate is used to
determine the information requirements. This means that the information
requirements for 100-1000t substances will be used as a basis for this
standard dossier. The fact that the substance is also used as an
intermediate should be indicated in the dossier and the volume of 1700
tonnes used as intermediates will need to be documented in the dossier.

If the manufacturer or importer of the substance manufactures or imports
it only for the use as an isolated intermediate under strictly
controlled conditions (see 2.1), then the manufacturer or importer can
submit a registration dossier with reduced information requirements
(according to *Article 17 and 18*) as described in section 2.2 and
section 2.3. However, this registration dossier has to contain all
available existing information on the intrinsic properties of the
substance.

More guidance on how to calculate the tonnage is given in section 1.6.2
of the Guidance on registration.

A fee must accompany any registration of an intermediate.

The data requirements for the registration of isolated intermediates
manufactured in quantities of 1 tonne or more per year depends on
whether they are transported or not. For transported intermediates,
those requirements depend on the volume manufactured or imported.
Compared to the data requirements for the registration of a "standard"
substance, there are reduced information requirements for isolated
intermediates, as long as the registrant confirms that strictly
controlled conditions are applied during manufacture and use of the
substance on-site but also, in case of transported intermediates, that
he has received confirmation from the user that strictly controlled
conditions are applied on other sites (*Articles 17(3)* and *18(4)*). In
case of a transported isolated intermediate in quantities of more than
1000 tonnes per year, also the information specified in Annex VII of
REACH should be included (*Article 18 (3)*).

It should be noted, though, that **monomers** used as on-site isolated
intermediates or transported isolated intermediates are not exempted
from standard registration requirements allowed for intermediates and
have to be registered following the registration requirements described
in *Article 10* (*Article 6(2)*). Therefore for the registration of
monomers the general guidance on registration has to be used.

For **on-site isolated intermediates** the information requirements on
physicochemical, human health and environmental properties are limited
to the data that is available to the manufacturer (e.g. information he
holds himself or that he can obtain from other information sources)
without any additional testing. The registrant shall therefore gather
all existing available information on physicochemical, human health or
environmental properties of the substance for which he submits a
registration dossier as required under REACH.

For **transported isolated intermediates** available existing
information needs to be submitted as for on-site isolated intermediates,
but a limited set of additional information needs to be generated, if
not already available, if the annual tonnage exceeds 1000 tonnes/year as
referred to in *Article 18* and developed under section
[2.3](#registration-requirements-for-transported-isolated-intermediates)
of this guidance.

The first task for the registrant is therefore to determine if the
substance under investigation is an isolated intermediate manufactured
and used under strictly controlled conditions and, whether it is
transported or not, in order to identify the information he has to
provide in a registration dossier to fulfil his obligations.

## Strictly controlled conditions 

For both on-site and transported isolated intermediates the possibility
to provide a reduced set of information for their registration applies
when:

-   *For on-site isolated intermediates, the manufacturer confirms that
    the substance is only manufactured and used under strictly
    controlled conditions in that it is rigorously contained by
    technical means during its whole lifecycle (Article 17(3)).*

-   *For transported isolated intermediates, the manufacturer or
    importer confirms himself or states that he has received
    confirmation from the user that the synthesis of (an)other
    substance(s) from that intermediate takes place on other sites under
    strictly controlled conditions* detailed in *Article18(4)*. For
    transported isolated intermediates that are manufactured in the EU
    the strictly controlled conditions shall apply both to the
    manufacture and use of the substance.

In order to be able to avail from the reduced registration requirements
the registrants have to first assess if their intermediates are handled
under strictly controlled conditions on the sites of manufacture and
uses. When filling his registration dossier using IUCLID[^1]5 the
registrant must report if the substance is manufactured and used under
strictly controlled conditions or not and can provide the confirmation
of this (see section 2.4).

To assess if the intermediate is manufactured and used under strictly
controlled conditions during its whole lifecycle, the registrant should
evaluate if the following conditions, as detailed in *Article 18(4)*,
are in place:

> \(a\) *the substance is rigorously contained by technical means during
> its whole lifecycle including manufacture, purification, cleaning and
> maintenance of equipment, sampling, analysis, loading and unloading of
> equipment or vessels, waste disposal or purification and storage;*
> (see chapter 2.1.1)
>
> *(b) procedural and control technologies shall be used that minimise
> emission and any resulting exposure;* (see chapter 2.1.2)
>
> *(c) only properly trained and authorised personnel handle the
> substance; (see chapter 2.1.3)*
>
> *(d) in the case of cleaning and maintenance works, special procedures
> such as purging and washing are applied before the system is opened
> and entered;*
>
> *(e) in cases of accident and where waste is generated, procedural
> and/or control technologies are used to minimise emissions and the
> resulting exposure during purification or cleaning and maintenance
> procedures; (see chapter 2.1.4)*
>
> *(f) substance-handling procedures are well documented and strictly
> supervised by the site operator.*

The definition of strict control in *Article 18(4)* for transported
isolated on-site intermediates can be used as a working basis for
isolated on-site intermediates also. *Article 18(4)* provides a wider
definition of strict control than *Article 17(3)* which is limited to
criteria (a) and (b) of the above list. This does not mean that criteria
(c) to (f) cannot also be appropriate criteria to determine strict
control also for on-site isolated intermediates. . This definition
covers both: (i) normal operating conditions and (ii) non-routine
operational circumstances such as maintenance and incidents.

For both types of intermediates, on the basis of the assessment and
description of the conditions under which the substance is manufactured
and/or handled on site(s) of both the manufacturer and the user in case
of transported intermediates, the registrant has two possibilities:

-   Submit a registration dossier containing the limited set of data
    requested for intermediates, provided that he concludes that the
    substance is manufactured and used under strictly controlled
    conditions.

-   Submit a full registration dossier as described in *Article 10*, if
    he is not able to conclude that the substance is manufactured and
    used under strictly controlled conditions.

*Article 18(4)* provides the basis upon which judgments should be made
by both manufacturers/importers and downstream user(s) on whether or not
\'strictly controlled conditions\' exist. Strictly controlled conditions
should be seen as a combination of technical measures that are
underpinned by management systems. This approach to managing human
health and environmental risks aligns with and acknowledges the existing
regulatory obligations that impact on chemical manufacturers (e.g.
control of accidents under Directive 96/82/EC[^2], Integrated Pollution
Prevention and Control under Directive 96/61/EC[^3], occupational
protection under the Chemical Agents Directive 98/24/EC[^4]). This
approach includes training, process controls, management systems,
monitoring, personal protective equipment (PPE) where combinations of
\'hardware\' and \'software\' measures (using, in some cases, a
hierarchy of preferences) strictly control risks. However it should be
kept in mind that the use of PPE, for example, should not have a prime
role when determining whether workplace exposures to an intermediate are
strictly controlled as the use of these measures, by definition,
indicates that exposures are either inadequately controlled or managed.
The use of such measures alone generally cannot equate to strictly
controlled conditions.

A full explanation of the strictly controlled conditions in place is not
required in the registration dossier, however the assessment of the
use(s) of any substance (or group of similar substances) as an
intermediate(s) should be documented within a company in order to show
the adequacy of the measures as authorities may request such information
which then must be made available. Where relevant, documentation for
compliance with other legislative frameworks can also be referred to.

The documentation may include:

-   justification for the assignment of use as an intermediate to the
    substance, including customers' statements if a transported isolated
    intermediate;

-   the relevant operating conditions;

-   the risk management measures implemented in the company and
    recommended to external customers; and

-   the corresponding exposure considerations;

-   reference or derivation of any relevant threshold value (e.g. DNELs,
    PNECs) including the relevant physico-chemical, toxicological and
    ecotoxicological data, including data from substance grouping.

The details of the risk management measures applied and recommended to
the user, which reflect the strictly controlled conditions, should be
included in the dossier. Existing legislative frameworks or industry
standards can be used when documenting the risk management.

To facilitate the process for assessing whether strict control is
achieved, Appendix 1 presents an indicative and non-exhaustive list of
issues that could be considered. This approach is only intended as a
user-friendly tool to document the process of assessing the conditions
of strict control. The actual process behind answering the questions
involves considerable analyses by relevant people (e.g. site managers,
engineers). Although transported isolated intermediates require
communication through the supply chain for confirmation that strictly
controlled conditions are achieved, the process for documenting strict
control does not require the interchange of information that could be
seen to constitute confidential business information (e.g. fine detail
of process technology and/or engineering, etc).

An example of a general format to document how the substance is
manufactured and used in strictly controlled conditions is also proposed
in Appendix 2. This should contain information and justification on the
relevant issues raised in Appendix 1. Please also note that any
information produced for the purpose of other pieces of legislation
(e.g. worker protection legislation) can of course be used as an element
to demonstrate strictly controlled conditions.

### Rigorous containment of the substance

In order to safely handle chemical intermediates, the chemical
processing industry integrates the concept of \"rigorous containment\"
into design engineering and operation for its manufacturing and
processing facilities. Rigorous containment is the combination of
technical and procedural measures that ensure that exposure (whether to
man or the environment) is reduced so that risks are strictly
controlled. It is applicable to handling intermediates at any scale.

In every case, the successful management of risk is central to the
concept of rigorous containment: when no hazard and risk information is
available, then intermediates have to be treated as hazardous
substances, with the accompanying need to ensure (and demonstrate) that
exposure is prevented. When information on hazard is available for an
intermediate, then the intermediate will be handled under appropriate
conditions that ensure that any risks rising from handling the substance
are strictly managed. Consequently, the way that rigorous containment
can be achieved may vary according to the knowledge of an
intermediate\'s physicochemical and hazard properties.

The intermediate needs to be rigorously contained by technical means
during its whole life cycle which includes the manufacture, the
isolation of the intermediate out of the reaction mixture, if necessary
further purification steps (e.g., distillation, re-crystallisation,
filtration), cleaning and maintenance, sampling, analysis, loading and
unloading of equipment/vessels, waste disposal/purification and storage,
and the use in synthesis.

To be able to confirm and document in-house the rigorous containment of
the substance, the registrant should characterise the processes during
its whole life-cycle and equipment used to characterise the level of
containment taking into account the properties of the substance.

The description of these technical means and conditions should allow the
identification of potential exposure of workers and the environment to
the substance. One way to do this is to assure the necessary level of
leakproofness of the different functional elements (pressurised vessels,
seals, sacks, containers, drums, etc.) involved during the different
steps of the whole process such as manufacture, transfer (filling,
emptying, etc.) or sampling of the substance when potential emission
could be expected to the workplace or the environment.

For example, isolated intermediate packaging and containers should only
remain open for short periods during equipment filling and emptying (via
hose lines, pipe joints), during sampling (transfer from one container
to another container via closed sampler) and when performing cleaning
and maintenance. Consideration should be given to the transfer and
management of the isolated intermediate in bulk through pipelines and
dedicated bulk storage facilities. Containers or equipment open for any
extended period of time should have suitable measures in place, which
will be consistent with the characteristics and properties of the
intermediate, e.g. efficient exhaust ventilation, to prevent any
significant release of the substance into the immediate surroundings
from the container.

Examples of technical measures that could be implemented in order to
ensure rigorous containment are given in examples 2 to 3 for workers and
environmental protection in different industrial sectors. Those examples
are in no way binding or exhaustive but illustrate the types of measures
that can be applied.

Example 2 Pharmaceutical industry: examples of technical measures for
workers and environmental protection.

Wherever possible, design containment is implemented to prevent exposure
of the worker. The design and selection of control technologies and
equipment is based upon a set of performance based criteria. The
selection of control measures that aim to control and prevent emissions
at source are prioritised. Examples of technical measures may include:

● Transfers using direct coupling and closed systems, also selected use
of unidirectionalised air flow booths. . Examples include:

● Engineered Airflow Device

● Ventilated enclosures e.g. laminar flow/powder containment booth

● Vertical process trains

● Special valving such as split butterfly valves

● Vacuum transfer

● Intermediate bulk containers

● Totally enclosed processes; transfers using direct coupling;
barrier/isolator technology. Examples include:

● Isolation technology e.g. isolators

● Intermediate bulk containers with split butterfly values

● Soft Wall Isolators (Glove bags)

● Alpha Beta Rapid Transfer systems on enclosures

● Specialised Vacuum transfer systems

Emissions and exposures of the environment are controlled by technical
measures.

Examples of technical measures to control emissions to the environment
may include:

● Waste gas incineration: complete destruction of waste gases at high
temperatures () for a specified minimum residence time, as calculated by
an engineer

● Condenser -- low temperature devices through which waste vapours are
sent causing them to liquefy and be collected.

● Scrubber -- number of types available. Usually packed columns around
which an appropriate scrubbing solution circulates, as specified by an
engineer. The waste vapours from a process and/or area are passed
through the scrubber causing the fumes to be trapped in the scrubbing
solution. The waste scrubber solution is then disposed of by
incineration.

● Hepa-filter -- a filter designed to trap small particles. The general
air from an area or a piece of equipment passes through the filter
before discharge to atmosphere. The contaminated filter is then disposed
of by incineration.

● WWTP -- a wastewater treatment plant is a biological system to which
the aqueous wastestreams from a process and washing/cleaning solutions
are sent. Microbes in the WWTP break down the organic constituents of
the wastestreams to CO2 and water before discharge into the environment.

● Cryogenic treatment is a very low temperature condenser which traps
all the condensable materials as a liquid or a solid. This liquid or
solid is then disposed of by incineration.

Example 3 Petrochemical Industry: example of technical measures for
workers and environmental protection.

Bulk petrochemical intermediates will invariably be handled in a
chemical plant of a high integrity that is designed to minimise
potential for emissions to air and water. Typical examples of control
measures and systems in place to deliver such strictly controlled
conditions, which would be expected to deliver control to \<1 ppm (for a
gas or volatile liquid), include:

● Enclosed transfers designed to prevent leaks e.g. self-draining
transfer lines

● High integrity methods of material loading and unloading (e.g dry lock
couplings, vapour capture and recovery)

● Plant designed to facilitate the draining and flushing of plant
equipment items prior to maintenance, with recycle and/or suitable
disposal of wastes

● High integrity (low emission) valve packings and flange seals

● In-line process controls and/or contained systems for process sampling

● Low emission pumps e.g. canned, magnetic, mechanical seals

● Routine monitoring and inspection for leaks to reduce fugitive
emissions

Example 4 Fine chemicals industry: examples of technical measures for
workers and environmental protection.

Handling intermediates in batch fine chemicals facilities will require
that the plant engineering and systems are designed to minimise
potential for emissions to air and water. Typical examples of control
measures and systems which might be encountered to deliver such strictly
controlled conditions, which would be expected to deliver control to
\<0.5 mg/m^3^ (for a solid), include:

● Material transfers via enclosed systems (e.g. semi-bulk containers
such as IBCs)

● Enclosed and vented charging systems (e.g. bag slitters with integral
package disposal)

● Discharging arrangements designed to minimise emissions (e.g. into
drums/kegs via pneumatic filling heads and continuous liners; vented
booths with exhaust scrubbing)

● Plant designed to facilitate the draining and flushing (and
detoxification) of equipment items prior to maintenance

● Maximal use made of automated process control systems to minimise
manual interventions

● Contained process sample systems (e.g. vented cabinets or sample
bombs)

If the information available to determine whether the substance is
rigorously contained during manufacture, use and handling, is not
sufficient, then reliable model calculations and/or monitoring data
could also be used to assess the exposure of workers or the environment
to the substance.

Product-based containment procedures depend on the form and use of the
substance, e.g. some degree of containment is inherent in a liquid or a
pasty substance with a very low vapour pressure or a solid that does not
release dust in repacking/decanting or processing activities. Where a
substance is in a matrix used for synthesis (e.g. masterbatch, glass,
plastic), containment depends on the potential migration of the
substance from the matrix.

### Procedural and control technologies to minimise emission and any resulting exposure

Any significant release of the substance into the wider environment
should be prevented through containment procedures, such as suitable
physical barriers (e.g. bunds) and/or chemical barriers (e.g.
membranes). Operations on site should be managed in order to ensure
containment within the site premises wherever possible, including
accident prevention, as specified under the section entitled Management
Systems.

An additional way to minimise emissions and resulting exposure is to
apply procedural and control technologies when emissions have been
identified. Such technologies allow to still consider the substance to
be rigorously contained. For example, in case of emissions to waste
water (including during cleaning and maintenance processes), it will be
considered that the substance is rigorously contained if the registrant
can prove that techniques are used to minimise the emissions by, for
example, incinerating the waste water or extracting the intermediate
from it. The same applies to emissions to air or disposal of wastes
where procedural and control technologies are used to minimise potential
exposure of humans and environment. The efficiency of any methods
applied to minimise emissions and resulting exposure should be described
and documented in-house.

Following an assessment of containment, the selection and use of further
risk management measures, equipment standards and safety procedures will
vary considerably across industry and be dependent on the process and on
the physico-chemical properties and the hazard of the substance, when
sufficiently well known.

### Handling of the substance by trained personnel

In order to minimise emissions and any resulting exposure, it is
important that only trained and authorised personnel handle the
substance (*Article 18(4)(c)*). As a minimum, the registrant should take
care that the workers who handle intermediates are provided with:

-   training and information on appropriate precautions, working
    procedures during the malfunctioning of the process and in
    accidental situations, and actions to be taken in order to safeguard
    themselves and other workers at the workplace.

-   access to a safety data sheet (SDS), which includes information on
    the hazardous properties of the substance, such as its identity, the
    risks to safety and health, relevant occupational exposure limit
    values (EU and national ones) and other relevant legislative
    provisions.

These procedures should apply to all personnel handling the substance
including during cleaning and maintenance works.

### Cases of accident and where waste is generated

There must be procedural and/or control technologies in place that are
used in cases of accidents and in cases where waste is generated
(*Article 18(4)(e)*). In this, the clarifications according to the
Directive 96/82/EC on the control of major-accident hazards involving
dangerous substances and the Directive 94/9/EC concerning equipment and
protective systems intended for use in potentially explosive atmospheres
might usefully be consulted.

### Management System 

Management systems are good options to ensure the proper application of
risk management measures. A management system should include the
relevant operational procedures to ensure that control measures are
indeed applied[^5]. Such a system may also define management
responsibilities, authorisation procedures (e.g. for maintenance or
opening of equipment, inspection and auditing requirements etc).

On any given site, a management system should contain reference to
procedures for accident prevention and response. It may be appropriate
to link this system to operational engineering control systems. In case
of a transported intermediate, the various parties involved (supplier
and customer) each will need a management system in order to ensure
rigorous containment and controlled conditions over the life cycle of
the intermediate.

## Registration requirements for on-site isolated intermediates.

On-site isolated intermediates manufactured in quantities of 1 tonne or
more per year have to be registered to the Agency. In order to benefit
from the reduced registration requirements for on-site isolated
intermediates, the manufacturer must confirm that the substance is used
and manufactured only under strictly controlled conditions during its
whole lifecycle as defined in *Article 17(3)* (see also section
[2.1](#strictly-controlled-conditions)).

The information required under *Article 17(2)* is the following:

-   **The identity of the manufacturer**: the information to be
    submitted is detailed in section 8.2.2.1 of the Guidance on
    registration.

-   **The identity of the intermediate**: the information to be
    submitted to identify the substance is the same as that to be
    submitted for a full registration (see section 8.2.2.1 of Guidance
    on registration) with the exception of analytical methods
    descriptions (section 2.3.5 to 2.3.7 of Annex VI) which are not
    required.

-   **The classification of the intermediate:** the information to be
    submitted is detailed in section 8.2.2.2 of the Guidance on
    registration.

-   **Any available existing information on physicochemical, human
    health or environmental properties of the intermediate:** when the
    registrant is in legitimate possession or has the permission to
    refer to a full study report (a full study report or study summary
    can be used freely after at least 12 years after its submission in
    the framework of a registration (*Article 25(3)*), he shall submit a
    study summary within his registration, unless in case of joint
    registration when the lead registrant submits the information (see
    section
    [2.5](#joint-submission-of-data-on-isolated-intermediates-by-multiple-registrants.)).
    How to prepare a study summary is described in section 8.2.2.4 of
    the Guidance on registration.

-   **A brief general description of the use:** only a brief general
    description of the identified use(s) of the substance as described
    in section 3.5 of Annex VI is required for isolated intermediates.
    More details can be found on what needs to be reported in section
    8.2.2.3 of the Guidance on registration.

-   **Details of the risk management measures applied**: the information
    to be submitted is detailed in sections 8.2.2.3 and 8.2.2.5 of the
    Guidance on registration.

If from the available information and knowledge of the process the
registrant is not able to conclude that the substance is manufactured
and used under strictly controlled conditions a full registration in
accordance with *Article10* has to be submitted as described under the
general registration guidance (Guidance on registration).

## Registration requirements for transported isolated intermediates

Transported isolated intermediates have to be registered to the Agency
if they are manufactured or imported in quantities of 1 tonne or more
per year. In order to benefit from the reduced registration requirements
for transported isolated intermediates, the manufacturer or importer
must confirm himself or state that he has received confirmation from
user(s) that the substance is used and manufactured only under strictly
controlled conditions during its whole lifecycle as defined in *Article
18(4)* (see also section [2.1](#strictly-controlled-conditions)).

Therefore the registrant of a transported intermediate should first get
the necessary confirmation from the different users to whom the
substance is supplied whether the substance is used under strictly
controlled conditions or not.

For transported isolated intermediates below 1000 t/a, the information
required under *Article 18(2)* is the following:

-   **The identity of the manufacturer or importer**: the information to
    be submitted is detailed in section 8.2.2.1 of the Guidance on
    registration.

-   **The identity of the intermediate**: the information to be
    submitted to identify the substance is the same as that to be
    submitted for a full registration (see section 8.2.2.1 of the
    Guidance on registration) with the exception of analytical methods
    descriptions (section 2.3.5 to 2.3.7 of Annex VI) which are not
    required.

-   **The classification of the intermediate:** the information to be
    submitted is detailed in section 8.2.2.2 of the Guidance on
    registration.

-   **Any available existing information on physicochemical, human
    health or environmental properties of the intermediate:** when the
    registrant is in legitimate possession or has the permission to
    refer to a full study report (a full study report or study summary
    can be used freely after at least 12 years after its submission in
    the framework of a registration (*Article 25(3)*), he shall submit a
    study summary within their registration, unless in case of joint
    registration when the lead registrant submits the information (see
    section
    [2.5](#joint-submission-of-data-on-isolated-intermediates-by-multiple-registrants.)).
    How to prepare a study summary is described in section 8.2.2.4 of
    the Guidance on registration.

-   **A brief general description of the use:** only a brief general
    description of the identified use(s) of the substance as described
    in section 3.5 of Annex VI is required for isolated intermediates.
    More details can be found on what needs to be reported in section
    8.2.2.3 of the Guidance on registration.

-   **Details of the risk management measures applied and recommended to
    the user**: the information to be submitted is detailed in sections
    8.2.2.3 and 8.2.2.5 of the Guidance on registration.

For transported isolated intermediates in quantities of 1000 tonnes or
more per year per manufacturer or importer the registrant shall include
in addition information specified in Annex VII of the Regulation. More
details can be found on what needs to be reported in the Guidance on
registration.

From the available information and knowledge of the process on the
different sites, or if no confirmation is available, the registrant may
not be able to conclude that the substance is used under strictly
controlled conditions. In that case, a full registration (including the
complete set of information as requested for "standard" substances and
described in the guidance on registration) has to be submitted taking
into account the manufactured or imported tonnage of the substance.

## Preparation of a registration dossier for isolated intermediates 

*Article 111* requires that the format of the technical dossier shall be
IUCLID (International Uniform Chemical Information Database). This means
that also other IT tools could be used to prepare the dossiers as long
as they produce the exact same format. In this document only the
preparation of registration dossier using IUCLID is described. The last
version of this software is IUCLID 5 which will be used as the reference
in this document and for which a specific guidance is available
(Guidance on IUCLID). The IUCLID 5 software will be downloadable from
the ECB website at
[[http://ecb.jrc.it/iuclid5]{.underline}](http://ecb.jrc.it/iuclid5) for
free by all parties, if used for non-commercial purposes.

The full registration dossier should be submitted via REACH IT to the
Agency as described in section 8.2 of the Guidance on registration.

For intermediates, IUCLID5 enables the registrant to identify the
information requirements for either on-site isolated intermediates,
transported isolated intermediates produced at up to 1000 tonnes and
transported isolated intermediates produced at 1000 tonnes or more. In
all cases, all available and relevant information need to be reported in
the registration dossier.

Depending on the selection of the registrant the fields to be filled in
IUCLID5 are clearly identified (see Guidance on registration).

## Joint submission of data on isolated intermediates by multiple registrants.

An isolated intermediate (on-site or transported) may be manufactured or
imported by several different registrants. In such situation joint
submission of some of the data shall be performed and the registrants
have to follow the general guidance developed for joint registration
(See Guidance on registration).

Specific rules apply to registrants of intermediates as specified in
*Article 19*.

Once the lead registrant has been identified, he has to submit first the
following joint information with the agreement of the other
manufacturer(s) or importer(s):

-   the classification of the intermediate, and

-   any available existing information on physicochemical, human health
    and environmental properties of the intermediate.

> Each registrant shall then submit separately specific information:

-   identity of manufacturer

-   identity of intermediate

-   a brief general description of the use (i.e. intermediate for
    chemical synthesis)

-   details of the risk management measures

If one registrant does not want to submit information on the
classification or on the physicochemical, human health and environmental
properties jointly, it is possible for him to do it separately, as far
as there is a clear and justified rationale of separate submission
according to the reasons set in *Article 19(2)*. These reasons are:

-   *it would be disproportionately costly for him to submit them
    jointly, or*

-   *submitting the information jointly would lead to disclosure of
    information which he considers to be commercially sensitive and is
    likely to cause him substantial commercial detriment, or*

-   *he disagrees with the lead registrant on the selection of this
    information.*

A general guidance on how to document reasons for submitted data
separately for joint registration is developed under the full
registration guidance.

## Time lines

The same rules apply for the registration of intermediates and the
registration of non intermediates. Section 1.7.1 of the Guidance on
registration describes those rules in detail.

Substances already notified under Directive 67/548/EEC, are considered
as registered. Nevertheless some provisions apply and details can be
found in section 1.6.5.3 of the Guidance on registration.

## Registration fee

A registration fee will be specified in a Commission Regulation one year
after entry into force REACH Regulation.

# APPENDIX 1: illustrative List of issues That may be taken into consideration for checking that the isolated intermediates are manufactured under strictly controlled conditions {#appendix-1-illustrative-list-of-issues-that-may-be-taken-into-consideration-for-checking-that-the-isolated-intermediates-are-manufactured-under-strictly-controlled-conditions .unnumbered}

> ***This list can be used by***

-   ***the registrant of an isolated intermediate (the manufacturer or
    importer) and***

-   ***the user of the intermediate wishing to confirm to the registrant
    that his use takes place under strictly controlled conditions***

The documentation needs to contain a justification of the relevant
issues listed below.

1.  **Has the lifecycle of the substance been accounted for**

```{=html}
<!-- -->
```
a)  Manufacture ?

b)  Any relevant storage ?

c)  Any processing ?

d)  Final synthesis process ?

```{=html}
<!-- -->
```
2.  **Are procedural and control technologies being used?**

```{=html}
<!-- -->
```
a)  The substance is rigorously contained

b)  Appropriate risk management measures are applied

c)  Management system is in place

```{=html}
<!-- -->
```
3.  **Are only properly trained and authorised personnel handling the
    substance?**

```{=html}
<!-- -->
```
a)  Relevant training or authorisation scheme covers this substance
    and/or process

b)  A procedure ensures that only trained and authorised persons handle
    the substance

c)  Other legislative frameworks that control the handling of the
    substance have been considered

```{=html}
<!-- -->
```
4.  **Are special procedures applied before the system is opened and
    entered during cleaning and maintenance works?**

```{=html}
<!-- -->
```
a)  Process procedures for containment during cleaning and maintenance
    have been accounted for in plant and engineering design

b)  Operational procedure system checks include cleaning and maintenance
    of process equipment

c)  Risk management measures are applied during cleaning and maintenance

d)  Procedures are applied such as purging and washing are applied
    before the system is opened

```{=html}
<!-- -->
```
5.  **Are procedural and/or control technologies used during
    purification or cleaning and maintenance procedures, including in
    case of accident or waste generation?**

```{=html}
<!-- -->
```
a)  Procedures to ensure containment have been applied for all stages of
    production and processing

b)  Operating system checks include accident prevention and waste
    management

```{=html}
<!-- -->
```
6.  **Are substance-handling procedures well documented and supervised
    by the site operator?**

```{=html}
<!-- -->
```
a)  Occupational procedures have been assessed and are documented

```{=html}
<!-- -->
```
7.  **For transported isolated intermediates:**

```{=html}
<!-- -->
```
a)  Confirmation that the synthesis of (an)other substance(s) from that
    intermediate takes place under strictly controlled on other sites
    has been documented

# APPENDIX 2: Example of format for documenting in-house information on strictly controlled conditions of isolated intermediates  {#appendix-2-example-of-format-for-documenting-in-house-information-on-strictly-controlled-conditions-of-isolated-intermediates .unnumbered}

> ***This format can be used by***

-   ***the registrant of an isolated intermediate (the manufacturer or
    importer) and***

-   ***the user of the intermediate wishing to confirm to the registrant
    that his use takes place under strictly controlled conditions***

1.  **Description of technological process used in manufacture**

2.  **Description of the uses of the substance.**

> *Give a description of the uses of the substance on the different
> sites.*
>
> *Check that any relevant storage, any processing and the final
> synthesis process of the substance have been accounted for.*

3.  **Is the substance rigorously contained?**

    a.  **During the manufacturing process ?**

-   Description of the process and technical means to contain the
    substance.

-   Identification of potential emissions to:

    -   Workplace

    -   Environment

-   Modelling estimations or available monitoring data if needed

    a.  **During the use .**

-   Description of the process and technical means to contain the
    substance.

-   Identification of potential emissions to:

    -   Workplace

    -   Environment (air, wastewater, soil, etc.)

-   Modelling estimations or available monitoring data if needed.

4.  **If emissions have been identified on sites of manufacture or uses,
    are there procedural and control technologies to minimise emission
    and resulting exposure?**

> *Give a description of these control technologies.*

5.  **Is the substance handled by trained and authorised personnel?**

-   Is the personnel provided with safety data sheet (SDS) of the
    substances handled?

-   Is there sufficient training and information on appropriate
    precautions and working procedures (proper labelling of specific
    working places) at workplace?

> *Give a description of the information and training in place.*

[^1]: International Uniform Chemical Information Database

[^2]: Council Directive 96/82/EC of 9 December 1996 on the control of
    major-accident hazards involving dangerous substances.

[^3]: Council Directive 96/61/EC of 24 September 1996 concerning
    integrated pollution prevention and control

[^4]: Council Directive 98/24/EC of 7 April 1998 on the protection of
    the health and safety of workers from the risks related to chemical
    agents at work.

[^5]: In practice management systems include the structure to respond to
    accidents and demonstrate compliance with relevant occupational and
    environmental legislation and/or standards.