UC Compliance for Intermediates

Chemical intermediates are widely used during the synthesis process of products such as pesticides, pharmaceuticals, veterinary medicine and so on. Usually, reduced data are required during the registration of chemical intermediates.  In this article, we will give a breif introduction of  the registration requirements for intermediates in EU, China and Korea, respectively.

Intermediate under EU REACH

Definition of Intermediate

According to the REACH regulation, chemical intermediate is defined as a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. The main implication of this definition is that the substance used as an intermediate will be reacted or used during the chemical reaction process, and will not be present in the final (end) product.

Categories of Intermediate under EU REACH

Under REACH, three types of intermediates are defined:

Type	Definition
Non-Isolated Intermediate	A substance that is manufactured solely for the purpose of being transformed into another substance (or synthesis) and is used up within this reaction. Non-isolated intermediate is not intentionally removed from the synthesizing equipment.
On-site Isolated Intermediate	A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which takes places on the same site and which is operated by one or more legal entities.
Transported Isolated Intermediate	A substance(for example, pharmaceutical intermediate) manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which is transported between or supplied to other sites.

Data Requirements under EU REACH:

Type	Tonnage	Data Requirement	Note
Non-isolated intermediates	Exempt from registration
Transported intermediates manufactured used under strictly controlled conditions (SCC*)	<1t/y	Exempted	Data Requirements are reduced under SCC condition. Manufacturer or/and downstream user needs to provide SCC confirmation letter.
	1-1000t/y	Provide available data (e.g. information he holds himself or that he can obtain from other sources)
	>1000t/y	Provide standard EU REACH 1-10t/y registration data.
Isolated intermediates not manufactured or used under strictly controlled conditions (SCC*)	<1t/y	Exempted	Data requirement increases with tonnage level.
	>1t/y	Standard REACH registration data requirement

Note: For on-site isolated intermediate under SCC, any available existing information on physicochemical, human health or environmental properties of the intermediate shall be provided.

Besides the available data on substance's intrinsic properties, the registrant still has to provide the following information:

• A brief general description of the use;
• Details of the risk management measures applied and recommended to the use;
• The identity of the manufacturer or importer;
• The identity of the intermediate;
• The classification of the intermediate;

To assess if the intermediate is manufactured and used under strictly controlled conditions (SCC) during its whole lifecycle, the registrant should evaluate if all the following conditions apply:

1. 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;
2. procedural and control technologies shall be used that minimise emission and any resulting exposure;
3. only properly trained and authorised personnel handle the substance;
4. in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
5. 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;
6. substance-handling procedures are well documented and strictly supervised by the site operator.

Intermediate under MEE Order 12 (China REACH)

Definition of Intermediate

Under China MEE Order No.12, intermediates refer to the chemical substances produced by the previous chemical reaction in the entire chemical reaction process, which are consumed in the next chemical reaction process and used to produce other chemical substances or products. Intermediates shall not appear in the produced chemical substances or products, except as impurities.

Categories of Intermediate under MEE Order 12

Intermediates are divided into two categories

Type	Definition
Non-Isolated Intermediate	Refer to intermediates that do not leave a reaction vessel or a reaction device, and also include those that are placed in the vessel for temporary storage after the reaction and used for the next chemical reaction in the same plant area
Others	Intermediates other than Non-isolated intermediates

Data Requirements under China REACH

Type	Tonnage	Data Requirement	Note
Non-isolated intermediate	Exempt from MEE Order 12
Intermediates other than Non-isolated intermediates	<1t/y	Record, without testing requirement	For chemical substances that are only used as pesticide intermediates, pharmaceutical intermediatesor veterinary drug intermediates, only basic data shall be submitted for new chemical registration under MEE Order 12.
	1-10t/y	Simplified registration
	>10t/y	Regular Registration

K-REACH

Under K-REACH, non-isolated intermediates or on-site isolated intermediates which can be technically blocked from leakage or exposure are exempted from registration.

Data Requirements under K-REACH

Type	Registration Requirement	Note
Non-Isolated Intermediate	Need to apply for exemption application	Process diagram should be provided
On-site Isolated Intermediate	Need to apply for exemption application	If the outflow or leakage could be blocked by technical means
Transported Isolated Intermediate	Shall be registered	With reduced data requirements, equals to normal substance with one-tier down level data requirements, with additionally several more data endpoints requirements.

Note: Imported chemical substances are not considered as intermediates;

Monomers/reactants of the polymers could not be regarded as intermediates;

Authority may conduct inspections on intermediate exemptions and registrations.

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