「Act on Registration and Evaluationof Chemical substance (Draft)」

Chemicals Management Division,
Environmental Health Policy Office,Ministry of Environment
Sep 1, 2011

Contents

Ⅰ. BackgroundⅡ. Overview of Act
Ⅲ. Details on Act
Ⅳ. Main Issues
Ⅴ. Enforcement Plan

1BackgroundBackground
Background of legislation- Increase of public interest in safety of chemical substances→ Public interest in safety management of chemical substance is increasing
But government evaluated only 15% of existing chemicals(total 43,000 kinds)- Promoting chemical industry to turn to green chemistry→ By reducing and restrictionㆍprohibition of substances of very high concern- Need to participate in international goals on chemical management→ To minimize the adverse effects of chemicals on human health and the environment
by 2020 (SAICM)※ SAICM(Strategic Approach to International Chemicals Management)

2

Overview of Act

「 Act on Registration and Evaluation of Chemicals」
Chemicals」- Not all existing chemicals are required to register- For priority assessment substance, Registration is required- Priority assessment substances can be pre-registered- If pre-registered, grace period is given to priority substances- When register the same chemical substance with other companies,
it is required to submit information jointly- Phase-out substance of very high concern in market by authorization
and restrictionㆍprohibition

Registration · Evaluation Process
CurrentsystemNewchemicals

Registration

HazardAssessment

Toxic
chemical
substances

New system

existingchemicals(prioritysubstances)
Registration

HazardAssessment

Newchemicals
Toxic
chemical
substances

Risk
Assessment

Chemical
substances for
authorization
or restriction

3

Details on Act

「 Act on Registration and Evaluation of Chemicals」
Chemicals」
ChapterCh.1
Ch. 2
Ch. 3

Ch. 4
Ch. 5

Ch. 6
Ch. 7

Provision

Ch. 1. General Provision (Article 1~8)
Purpose (Article 1)- To prevent adverse effects of chemical substances on human health and theenvironment by the registration and evaluation of chemical substances

Definitions (Article 2)- To define priority assessment substances and chemical substances for authorization,restriction·prohibition※ (Priority assessment substances) Amongst existing chemical substances, designated by theMinistry of the Environment based on trading volume and use, etc※ (Substances for authorization) a substance of high concern which requires permission
by the MOE prior to manufacture, import and use※ (Substances for restrictionㆍprohibition) a substance of high risk which is restricted or prohibitedfrom manufacture, import, use and sale in certain or all use

Scope of Act (Article 3)- The act is not applicable to chemical substances whose registration*evaluation is
subject to other acts such as pharmaceuticals and pesticides and so on.

Only representative (Article 6)- A foreign manufacture who intends to perform obligations required to a importer under
this act shall appoint a legal entity in Korea as an only representative.

Ch. 2. Registration of Chemical substances (Article 9~23)
Reporting of Manufacture or Import of Chemical Substances (Article 9)- In the case of existing chemicals(≥0.5ton/y), companies(manufacture or importer) are
required to report the volume of manufacture or import of the previous year to MOE

Designation of Priority Assessment Substances (Article 10)- Amongst existing chemicals, assessment chemical substance shall be designatedbased on use and trading volume, etc. and published them.

Pre-registration and Grace Period (Article 12~13)- Priority assessment substance shall be subject to pre-registration.
- Maximum 8 years grace period shall be granted to pre-registered chemicalsubstances.

Registration (Article 15~16)- Manufacturer or importer of new chemical or priority substance shall submit aregistration to the Ministry of the Environment- In case of registration, information on hazard, risks of chemical substance and otherinformation(e.g use) shall be submitted

Ch. 2. Registration of Chemical substances (Article 9~23)

Modification of Registration (Article 19)- In case of modification to registration due to increased manufacture or import
volume or confirmation of new uses, modified or added data shall be submitted

Joint Submission of Registration Dossiers (Article 20~21)- Companies of the same chemical substances are required to submit registration
data jointly- Existing data may possibly be submitted with the approval of data owner

Prohibition on Repetitive Generation of Test Data (Article 22)- Duplication of vertebrate animal test for registration is prohibited.

Measures on Dispute over Data sharing (Article 23)- In case of refusal or forced approval of data sharing without justification,
the submission of data for registration can be banned

Ch. 3. Evaluation of Chemical substances (Article 24~29)

Hazard assessment and notice of hazard assessment results (Article 25~26)- MOE(NIER) conducts hazard assessment of registered chemical substances- Notice of hazard assessment results by MOE

Risk assessment (Article 27)- MOE(NIER) conducts risk assessment
For ① substances manufactured or imported more than 100t/y and② substances considered to be in need of risk assessment after hazard assessment- Chemicals of very high concern based on a risk assessment shall be designatedas substances for authorization by use or for restriction or prohibition

Ch. 4. Authorization and Restriction of Chemical stances (Article30~36)

Authorization of chemical substances (Article 30~33)- Companies who intend to manufacture, import and use of substances for authorization
are required to obtain prior permission from MOE- The authorization is valid only during the authorization period

Restriction or prohibition of chemical substances (Article34~36)- Based on a risk assessment, substance of high risk is designated as substance forrestriction or prohibition by MOE- Compliance with restriction·prohibition is mandatory in case of manufacture,import, sale, use of substances for restriction or prohibition.
- In the case of product containing a certain level of substance for restriction,
the name·content and use of the substance need to be reported to MOE.

Ch. 5. Communication on Chemical substances (Article 37~40)

Provision of Chemical Evaluation Result (Article 37~39)- In supplying priority assessment substances, some information concerning their hazard
shall be provided to the recipient.
- In supplying a substance for authorization, details of authorization, etc shall beprovided to the recipient.
- In supplying substances for restriction·prohibition, details of restriction or prohibition
shall be provided to the recipient.

Modification of Information Provided (Article 40)- In case of modification to provided information, modifications shall be notified to
the relevant supplier- MOE may request submission or modification of information for prevention of risk

4Main issues

Main Issues
1. Priority assessment substances- The draft list are planned to be released publicly in early 2013 and will be decided officially
6 months(or more) before the start of pre-registration- Criteria for prioritization : exposure level → quantity(national level), use
hazard level → CMR, PBT, H410, Toxic substance(under TSCA)

2. Data requirements and tonnage level- We are now studying reasonable data requirements and tonnage level.(the draft may bereleased next year)- Registration limit(0.5t/y) is more reasonable than 1t/y in Korean market,
But we are considering some ways to minimize the burden to registrants below 1t/y

3. Exemption- R&D, un-isolated intermediate and polymer of low concern will be exempted from
reporting, registration, authorization and restriction

Main Issues
4. Reporting(Article 9)- Reporting is a very essential factor for designation of priority assessment substances- Considering the possible difficulties to industry caused by reporting,
we are searching for more rational ways to remove unnecessary burden

5. Grace period for priority 1 substance(2 years)- Priority 1 substance is the most urgent one for assessment→ We are not considering to expand grace period for priority 1- There will not be too many priority 1 substances- Total number of priority 1, 2, 3 substances may be 2,000~3,000 .
※ Designating priority 4 substances by reviewing information gathered from reporting5Enforcement Plan

Enforcement Plan (draft)

Enforcement

Registration of new chemicals
Presidential& Ministerial
DecreePassage ofAct
Through
National
Assembly
Dec. 31. ’11.

Jan. 1. ’13.

Priority
substanceFor
preregistration

Jan. 1. ’14.

Content declaration ofrestrictionprohibition
substance

2~8 years’transition period
for pre-registered substanceJune. 30. ’14.

Jan. 1. ’17.

June. 30. ’22.

Chemicals Management Division,
Environmental Health Policy Office