Medical Items & Cosmetics Policy

Shoplazza reminds sellers of some of our rules for listings.

Health claims and misuse of keywords: Listings containing health claims and misusing terms such as "virus" or "epidemic" are prohibited.
Prices inflated above market value: Listings that attempt to profit from tragedies and disasters (such as the Coronavirus outbreak) are prohibited.

Laws and regulations: We recognise this is an evolving situation. We advise sellers to always check local laws and regulations when listing. We will continue to monitor the situation globally and provide further updates as necessary.

Activity that doesn't follow Shoplazza listing policies could result in a range of actions, such as Shoplazza ending or canceling your relevant listings, hiding or demoting all listings from search results, enforcing buying or selling restrictions, or suspending your account.

Sale of Personal Protective Equipment (PPE)

There are now restrictions on the sale of certain Personal Protective Equipment (PPE) (disposable face masks; disposable gloves; disposable gowns; goggles, glasses or eye visors; alcohol wipes; and hand sanitiser). These restrictions apply to all Shoplazza sellers who list or are approved to list the items above.

China export: Ministry of Commerce, General Administration of Customs and State Drug Administration on March 31, 2020 jointly issued the "Announcement on the orderly export of medical supplies" (Announcement No. 5 of 2020):

"Since April 1, the export of new coronavirus detection reagents, medical masks, medical protective clothing, respirators, infrared thermometers to the customs declaration of enterprises, shall provide Written or electronic statement, commitment to export products have been obtained in China

1) medical device product registration certificate,

2) meet the quality standards of the importing country (region) requirements. Customs inspection and release with the medical device product registration certificate approved by the Drug Administration.”e.g. CE marking or FDA marking

Non-medical mask manufacturers need to fill in the "List of Non-medical Mask Manufacturers That Have Obtained Foreign Standard Certification or Registration".

Medical mask manufacturers need to fill in the "List of Medical Material Manufacturers That Have Obtained Foreign Standard Certification or Registration".

See the table below:

Mask Type	Agreed on applicable standards	Regulatory basis	Qualification requirements
Medical masks	Chinese standard	Announcement 5 www.nmpa.gov.cn	Medical device product registration information can be found on the website of the Food and Drug Administration
Medical masks	Foreign standard	Announcement 12 www.cccmhpie.org.cn	In the "white list" of medical supplies (medical masks) of the Medical Insurance Chamber of Commerce
Non-medical masks	Chinese standard	Announcement 12 www.samr.gov.cn	Not on the "blacklist" of the State Administration for Market Regulation
Non-medical masks	Foreign standard	Announcement 12 www.cccmhpie.org.cn	In the "white list" of non-medical masks by the Medical Insurance Chamber of Commerce

Australia: The changes make it an offense to re-sell PPE purchased at retail for more than 120% of its purchase price. The Determination applies to the resale of items purchased since 30 Jan 2020. In addition, the Government has introduced restrictions banning these items from export.

USA: The Food and Drug Administration (FDA) continues critical work to protect public health, including the review of shipments of medical devices offered for import during the COVID-19 pandemic. Below are certain Personal protective equipment authorized by an EUA (Emergency Use Authorization).

Generally, respirators labeled as "respirators" intended for a medical purpose must be cleared or authorized by the FDA or approved by NIOSH prior to importation.

The FDA's EUA for face masks describes the conditions under which face masks are authorized for emergency use. Please refer to the following use of:

(1) Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection; and

(2) Other powered air purifying respirators (PAPRs) approved by NIOSH, in

accordance with 42 CFR Part 84, and that are listed on the NIOSH CEL for PAPRs with particulate protection;

Other PPEs:

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.

Below is a list of products and certain product codes authorized by an EUA. A complete list of product codes may be found in corresponding enforcement policy guidance documents identified below:

NIOSH-Approved Respirators
Face Masks (Non-Surgical)
Surgical Masks
Gowns and Other Apparel
Diagnostic Tests Kits
Ventilators and Ventilator Accessories
Face Shields
Extracorporeal Blood Purification Devices
Infusion Pumps and Infusion Pump Accessories
Diaphragmatic Pacing Simulator Systems
Continuous Renal Replacement Therapy and Hemodialysis Devices
Remote or Wearable Patient Monitoring Devices
Respiratory Assist Devices

For additional information, see:

European Union: PPE made available on the EU (including EFTA/EEA) market must be in conformity with the applicable EU legislation. For PPE that is the Regulation (EU) 2016/425. Depending on the type of PPE and the intended purpose, also other legislation might be applicable (e.g. REACH is always applicable). This is still valid during the COVID-19 health crisis.

Importers shall also indicate their name and address on the PPE (or at least on the packaging).

Importers must make sure that the required documents accompany the product (i.e. user instructions and Declaration of Conformity) and this in the necessary language(s).

For the complete list of obligations of importers, see article 10 of the PPE Regulation.

Also distributors of PPE have obligations described in the PPE Regulation. They have to check if the CE marking is on the product and that the required documents accompany the product in the necessary language(s).

For the complete list of obligations of distributors, see article 11 of the PPE Regulation.

See also the guidance document "How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context "published by the EU Commission. Further information on the EU PPE Regulation is available on the PPE webpage of the EU Commission DG GROW.

Sale of Dietary Supplements

Shoplazza reminds sellers to comply with the following requirements.

Product images must meet the following requirements:

Must be legible
Must clearly show the entire product label (all sides), including the applicable facts panel, ingredients list, certification logos, identity statement, instructions for use, and any product warnings
Must contain the product name
Must contain the name and contact information of the brand owner or manufacturer
Must be a direct image of the product or its packaging. A computer-generated image or mock-up will not be accepted.
These images must appear on the detail page of your product.

Product description must comply with the description compliance requirements:

This product is not a substitute for medication.

USA: Dietary Supplements can be beneficial to your health — but taking supplements can also involve health risks. The U.S. Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed.

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.

For additional information: https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplement

UK: In the UK, food supplements are required to be regulated as foods and are subject to the provisions of general food law. In Northern Ireland, EU food law relating to food supplements will continue to apply, as listed in the Northern Ireland Protocol.

Brexit: After Brexit, from 1 January 2021 the UK has its own list of Vitamins and Minerals for use in Food Supplements and modification processes in Great Britain. For further information on these requirements, visit The Nutrition (Amendment etc.) (EU Exit) Regulations and see Guidance notes on legislation implementing Directive 2002/46/EC on food supplements.

European Union: According to the EU General Food Law Regulation (EC) No 178/2002, food supplements are considered as foodstuffs. Responsibility for the safety of these products lies with the food business operator placing the product on the market.

Please note that Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use in that territory.

For additional information: https://www.efsa.europa.eu/en/topics/topic/food-supplements

Sale of Cosmetics

Shoplazza reminds sellers to comply with the following requirements.

Labeling Requirements

Cosmetic labeling must be truthful and not misleading. A basic label must include the following information:

An identity statement, indicating the nature and use of the product
An accurate statement of net content
Name and place of business.
Distributor statement: manufactured by xxx or distributed by xxxx
Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded
Warning and caution statements.
Ingredients.

To be noted, Ingredients must be identified by their "common or usual names" in English in descending order of predominance on product labels in the United States and European regions.

European Union: When you import cosmetic products on the European market, they must comply with the Cosmetic Regulation No 1223/2009, no exceptions, even if your cosmetic product complies with another cosmetic regulation.

For additional information: https://ec.europa.eu/health/system/files/2016-11/cosmetic_1223_2009_regulation_en_0.pdf

Requirements on Ingredients

The EU has regulations that specifically prohibit or restrict the use of certain hazards ingredients in cosmetics. Please check via ANNEX II: LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS (page 25):

https://ec.europa.eu/health/system/files/2016-11/cosmetic_1223_2009_regulation_en_0.pdf

Specific topics

Some cosmetic products deserve special attention from regulators due to their scientific complexity or higher potential risk to consumer health.

USA: The two most important cosmetic laws in the US are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). Under these laws, cosmetic products and ingredients do not need FDA pre-market approval, with the exception of color additives.

Cosmetic manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics into the United States.

However, the marketing of adulterated or misbranded cosmetics is prohibited.

The adulterated products include cosmetic products bearing or containing any poisonous or deleterious substances that may pose harm to users under normal conditions of use and contaminated cosmetic products.

The misbranded products included improperly labeled products and deceptively packaged products. Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety and labeling of their products.

Examples: include skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants (excluding soap).

Requirements on Ingredients

FDA has regulations that specifically prohibit or restrict the use of certain hazards ingredients in cosmetics (example, Chloroform, mercury compounds, view list).