Small science! Wet wipes exported to the United States FDA or EPA?

Release time:

2020-08-25 11:47

The epidemic has changed the whole world and everyone's living habits. The global demand for wet wipes has increased, but the export of wet wipes to the United States is subject to different regulations depending on the use. Before exporting, be sure to confirm the direction of compliance.

Wipes 1. Therapeutic Purposes-Drug OTC FDA Registration

Most alcohol wipes and benzalkonium chloride wipes now exported to the United States are used for therapeutic purposes, such as killing bacteria on the skin or treating other skin conditions such as acne. These wipes are used on the surface of the human body and are registered as OTC drugs in the FDA regulatory category.

Before a drug can be placed on the market, it must meet FDA-approved safety and efficacy requirements. The drug is regulated by the FDA's Center for Drug Evaluation and Research.

Division I for drug OTC registration cycle within 3 weeks, the price is not expensive.

2. Wet Wipes Used for Surface Disinfection-U.S. Environmental Protection Agency EPA.

Wipes designed to control bacteria on inanimate surfaces and wipes containing ingredients such as insect repellents are regulated by the U.S. Environmental Protection Agency EPA and must be registered with the EPA prior to marketing.

Compared with FDA OTC registration, EPA registration cycle is very long and the price is particularly expensive. Our company will give customized declaration scheme according to specific substances.

3. baby wipes and other clean skin wipes-FDA cosmetic registration

Wipes designed to clean or moisturize the skin, such as personal cleansing wipes for baby care, hand washing, makeup removal, etc., should be used as cosmetics.

FDA cosmetics registration is not mandatory registration, FDA's legal authority on cosmetics is different from FDA's authority on other FDA regulated products (such as drugs, biologics and medical devices). By law, cosmetics and ingredients do not require pre-FDA market approval, with the exception of pigment additives. However, FDA can pursue enforcement actions against companies or individuals that violate the law for products on the market that do not comply with the law.

In general, with the exception of pigment additives and ingredients that are prohibited or restricted by regulation, manufacturers may use any ingredient in a cosmetic formulation, provided that: The ingredient and the finished cosmetic product are safe under the conditions of use regular the label or the product has been properly identified and the use of the ingredient does not result in adulteration or misuse of the brand by FDA-enforced laws.

The benefit of cosmetic FDA registration is access to important information about cosmetic ingredients. The FDA enters all information obtained from the VCRP into a computer database. If a cosmetic ingredient currently in use is deemed harmful and should be banned, the FDA will notify the manufacturer or seller of the product through a directory in the VCRP database. If your product is not in the registration database, the FDA will not be able to notify you. Avoid product recall or import withholding due to ingredient problems. If a cosmetic manufacturer files a product formula with VCRP, the FDA will remind the manufacturer to pay attention as long as it finds that the manufacturer has used unapproved pigment additives or other prohibited ingredients in the formula. In this way, manufacturers can modify product formulations before the product is imported or sold, thereby eliminating the risk of product recalls or withholding due to the use of improper ingredients. Help retailers identify safety-conscious producers. Retailers (e. g., department stores) sometimes ask the FDA if a cosmetics company is registered with the FDA. While registration does not indicate FDA approval, it does indicate that your product has been reviewed by the FDA and entered into a government database. The FDA will notify you if you submit a product formulation that is incomplete or contains a banned ingredient or unapproved color additive.

Do you understand the responsibilities and obligations that need to be fulfilled after the registration of new chemical substances?

Interpretation of the main points of the Guidelines for the Registration of Environmental Management of New Chemical Substances (Draft for Comments)

Do you understand the responsibilities and obligations that need to be fulfilled after the registration of new chemical substances?

Interpretation of the main points of the Guidelines for the Registration of Environmental Management of New Chemical Substances (Draft for Comments)

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