[Manual of Requirements and Procedures]

- Focusing on Cosmetics Containing Nano-Materials -

■ Overview

ㅇ Nano-materials are also used in cosmetics that come into direct contact with the human body due to the diffusion of NANO substances, resulting in the risk of human health and ecosystems such as bio-remnants or toxicity. As a result, the European Union (EU) effectively controls hazardous nano-materials to regulate these nano-materials by reporting or registering nano-materials in the Cosmetics Act in Registration Evaluation Authorization and Restriction of Chemicals(REACH), and the EU Member States.

ㅇ It is a regulation that protects human health at a high level by establishing the standards of the cosmetics to be released to the market, and ensures internal market function. The main requirements and regulatory contents and import customs procedures of cosmetics containing nano-materials will be focused on below.

■ Related Institutions and Relevant Statutory Provisions

☉ Related Institutions

ㅇ European Chemicals Agency(ECHA)

ㅇ The competent authorities of each Member State of the European Union (EU) (MSCAs)

☉ Relevant Statutory Provisions

ㅇ Cosmetics Act (REGULATION(EC) No.1223/2009 OF THE EUROPEAN

PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products)

ㅇ Registration, evaluation, authorization, restriction of chemical substances (Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH))

■ Obligatory Enforcement Body

ㅇ Manufacturers, importers and agents within the EU

■ Applicable Objects

ㅇ Cosmetics containing NANO-material

ㅇ Regulations for Nano-materials of Registration Evaluation Authorization and Restriction of Chemicals(REACH)

- Consider definition of chemical includes nano-materials

- Subject to register if it is nano-material itself or intentionally released nano-materials in articles

- Treats as same substance in case of same chemical structures or composition with existing chemical substances within REACH

- Nano-materials with an annual usage of less than 1ton is not subject to REACH and therefore lack legal control

■ Major Requirements and Regulatory Details

☉ Definition of Nano-materials

ㅇ A NANO-material is defined as an intentionally produced material that is insoluble or bio-persistent and has one or more outside diameters or internal structures are between 1 and 100nm.

ㅇ (Definition of nano-materials of EU Commission) In October 2010, the European Commission declared that nano-materials are defined as:

- The composition with a particle having one or more dimensions (width, length or height) in the range of 1 to 100nm and over 1% of the particle size distribution

- A substance having an internal or surface structure with at least one dimension having a range of 1 to 100nm

- A substance having a specific surface area greater than 60㎡/㎤ except for substances containing particles smaller than 1nm

☉ Notification of Cosmetics Containing Nano-materials

ㅇ Subject to notify

- All cosmetics using nano-materials for purposes other than colorants, preservatives or UV-blocking agents in accordance with Article 13 of the Cosmetics Act

ㅇ Information required for notification

- Information on other nano-materials specified in the Preamble 2 of Annexes 2 to 6 in chemical name(IUPAC)

- Estimated annual market launch volume of nano-materials in cosmetics

- Toxicological properties of nano-materials

- All safety data of nano-materials related to cosmetics classification

- Reasonable and predictable exposure conditions

☉ Labeling of Cosmetics Containing Nano-materials

ㅇ All ingredients present in the form of nano-materials are clearly marked on the ingredient list and '(Nano)' labeling is required for the name of the ingredient in parentheses.

■ Latest Trends on Nano-materials in EU Member States

☉ France

ㅇ The French Food Safety and Environment Labor Agency has notified the following laws that mandates reporting of companies to produce, distribute and import nano-materials and it has been in force since 2013.

- Target: Nano-materials with an annual usage of 100g or more

- Due date of notification: By April 30 of each year

- Legal action: fine of €30,000 and fine of €300 per day

- Nano-materials are substances that are concerned with human health or environmental impact and are based on particles of 1 to 100nm size, including mixtures containing free nano-particles (fullerene, carbon nanotubes, graphene, etc.)

☉ Belgium

ㅇ Belgium has introduced a notification system for tracking all life cycle of nano-materials used since January 2017.

☉ Denmark

ㅇ Denmark established a registration body for nano-materials and their products in 2013 and let information on products manufactured or imported from June 20 of each year to June 20 of the following year to be notified to Danish Environmental Agency before August 30th of the following year.

☉ Germany

ㅇ Germany has announced a plan to design a European registrar for products containing nano-materials after reviewing the legal feasibility of the registration of nano-products. Therefore, Germany is proposing to establish an EU-level registrar over individual countries in order to prevent duplication of regulations and simplify administrative procedures.

☉ Norway

ㅇ Nano-materials have been registering with common substances since 2012 and the amount of distribution of the substances distributed every year is managed in Norway.

☉ Austria, Belgium, Czech Republic, Italy, Luxembourg, Netherlands, Sweden, Croatia

ㅇ The above countries also manage nano-materials with requiring legislation proposal or market inspections for the registration of nano-materials or products containing nano-materials to the EU Commission.

■ Procedures of Customs Clearance

The process of import customs clearance in the EU basically pass through the following procedure according to the logistics flow.

① Submitting Pre-Import Declaration (ENS):

ENS (pre-import declaration) must be submitted 24 hours before shipment of marine transport and 4 hours before arrival of air transport and 1 hour before arrival of road transport through the entry management system (ICS) of the customs office at the first port of entry

② Arrival of Imported Goods:

The customs authorities examining the contents of the ENS (pre-import declaration) will issue an Arrival Notice if it is determined that there is no risk of cargo, and if it is determined to be a high risk item, a prohibition against shipping also can be taken.

③ Apparatus / Customs Presentation of Goods:

When the imported goods arrive at the port, they must be temporarily placed under customs control and presented to customs.

④ Import Declaration (Standard Declaration and Simple Declaration):

Standard import declaration must be made to the competent customs office using the Single Administrative Form (SDA) within 3 hours after the cargo arrives.

⑤ Inspection of Document/Articles and Confirming Import Requirements:

The Customs shall check the accuracy of the import declaration contents including the quantity, amount, HS classification, and proof of origin of the goods and whether the import requirements of each item are fulfilled and request additional documents, inspect documents and carry out spot inspection if necessary.

⑥ Payment of Customs Duties:

The customs duty is paid to the customs office of the first port of entry where the import declaration is made, and the value added tax (VAT) is paid to the destination country.

⑦ Taking Out for Free Distribution:

If payment of duties, etc. and all other import requirements are met, the goods can be taken out for free distribution.