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Indonesia Implements Regulation for Supervision on Manufacture and Circulation of Cosmetics 2020

The regulation revises the definitions of Manufacture and Circulation, clarifies the responsibilities of notification number owners and distribution business operators, supervision targets, items, and methods.

On Feb 5, 2020, Indonesia implemented amended Regulation for Supervision on Manufacture and Circulation of Cosmetics [1]. Business operators who already obtained notification numbers before Feb 5, 2020, shall adjust their products to comply with the new regulation within one year.

The main contents are as follows.

1. Definitions of “Manufacture, Circulation” are revised.

Manufacture: Manufacture is an activity or process of producing, preparing, processing, forming, packaging, or changing the form, quality control, and quality assurance of cosmetics preparations.

Circulation: Circulation is every activity or series of distribution or delivery of cosmetics both in the context of trade, not trade, or ownership transfer.

And definitions of “notification number owner, storage place, business operator, distributor, agent, retailer, single-level direct selling, multi-level direct selling, modern store, traditional market, pharmaceutical services facilities, principal and intermediate product” are newly added.

2. Responsibilities of notification number owner and distribution business operators.

Notification   Number Owner

Be responsible for cosmetics manufactured,   imported or circulated

  • Report the manufacture, importation or distribution activity to   the competent authority every six months (Report   template)

  • Save samples of cosmetics manufactured or circulated.

Distribution   Business Operators

Be responsible for cosmetics distributed

The responsibilities include guarantees   for:

  • Distributed cosmetics have been notified

  • Distributed cosmetics are not expired

  • Cosmetics storage is done well

3. Supervision targets, items, and methods

  • Targets

Supervision of cosmetics manufacture and distribution is carried out through inspection of facilities and cosmetic products. Commissioned manufacture and foreign cosmetics enterprises whose products circulated in Indonesia are also subject to supervision.

  • Items

Targets

Coverage

Items

Facilities

Facilities of notification number owner

Cosmetics industry

  • administrative documents

  • GMP application

  • PIF

Importers engaged in the field of   cosmetics

  • administrative documents

  • procurement and distribution documents

  • PIF

  • ownership or mastery of cosmetics storage place

  • cosmetics storage method

  • technical competence of responsible person

Individual business or business entity in the field of cosmetics who entered into a production contract

/

Distribution facilities

  • distributor

  • agent

  • sub-distributor or sub-agent

  • wholesaler

  • retailer

  • health care facilities

  • pharmaceutical services facilities

  • salon and spa

  • direct selling on a single level or multi-level

/

Cosmetic   products

/

  • Legality

  • Safety, benefits, and quality

  • Marking and claims

  • Promotion and advertising

  • Methods

1) Routine inspection. Routine inspection is conducted to check whether the products comply with standards or requirements.

2) Special inspection. Special inspection is conducted for follow up supervision results and information or indication of violations.

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