Products Covered by a Responsible Person: What Eldris Represents

Eldris represents consumer products and cosmetics, and one registration per market covers every type you sell. The onboarding form lists types such as electronics, cosmetics, toys, clothing, food contact materials and PPE. Products covered by the GPSR, Regulation (EU) 2023/988, follow its Article 16, while medical devices follow Article 11 of Regulation (EU) 2017/745.

Which product types can you choose at sign-up?

The onboarding form lists eight product types. You select every type you sell. One registration per market then covers all of them.

• General consumer goods
• Electronics & electricals
• Cosmetics & beauty
• Toys & children's goods
• Clothing & textiles
• Food contact materials
• PPE / safety equipment
• Other / not listed

Also, the monthly plan, priced by SKU count, stays the same whatever the type. The list is a set of categories to choose from. It is not a promise that Eldris covers every product in each one.

The last option, Other / not listed, is there for goods that fit none of the named types.

Eldris's terms cover two kinds of product. One is cosmetics, under Regulation (EC) No 1223/2009. The other is general consumer products, under Regulation (EU) 2019/1020.

A seller of both does not need two appointments. EldrisAi OÜ holds both roles under one.

If you add a product or SKU later, your certificate regenerates on its own. The new certificate itself has no fee.

You choose your product types at onboarding. The short answer is also in the FAQ entry on product coverage.

What happens to products covered by their own EU safety rules?

The GPSR leaves the Responsible Person rule to their own law. Its Chapter III, Section 1 does not apply to products covered by specific Union harmonisation legislation. That section holds Article 16.

Start with products covered by the GPSR. Article 16(1) says such a product may not be placed on the market without an economic operator established in the EU. That operator has the tasks in Article 4(3) of Regulation (EU) 2019/1020.

The guide to what a Responsible Person does sets those tasks out.

Products covered by the acts in Article 4(5) of that law need an EU operator too. Its Article 4(1) lets such a product on the market only with one. That operator has the same tasks.

The carve-out sits in Article 2(1) of the GPSR. It switches off the section that runs from Article 9 to Article 18.

Cosmetics sit outside both. They have their own law and their own Responsible Person. The short below asks which risks the GPSR covers for goods with their own EU safety rules.

Which EU product laws use the same operator role?

Those listed in Article 4(5) of Regulation (EU) 2019/1020. They include the rules on toys, electrical goods, radio equipment, machinery and PPE.

The list names each act by number. Among them:

• Toys: 2009/48/EC
• Low-voltage electrical goods: 2014/35/EU
• Radio equipment: 2014/53/EU
• EMC: 2014/30/EU
• Hazardous substances (RoHS): 2011/65/EU
• Machinery: 2006/42/EC
• PPE: Regulation (EU) 2016/425

The list here follows the original text of Regulation (EU) 2019/1020. Its Article 4 applies only to products covered by the acts on that list. A product outside that list follows GPSR Article 16 or its own law instead.

For products covered by these acts, the EU operator can be an authorised representative with a written mandate. That is Article 4(2)(c).

Eldris's service page lists Regulation 2019/1020, the toy rules and the low-voltage rules with full coverage, under one appointment. But Eldris does not prepare declarations of conformity or technical files. You or your test laboratory do.

The EU authorised representative page sets out that role for CE-marked goods.

How are cosmetics covered?

Under their own law. Article 4(1) of the Cosmetics Regulation lets a cosmetic on the market only with a Responsible Person designated in the EU. Eldris can hold that role under the same appointment as your other goods.

So cosmetics are not among the products covered by GPSR Article 16. For an imported cosmetic, each importer is the Responsible Person for the product it places on the market.

The importer may also designate a person in the EU by written mandate. That person accepts in writing.

One registration per market then covers every type you select, cosmetics included.

Two points differ from other goods. First, the appointment does not produce the safety report (CPSR) or the product information file (PIF). Second, as your Responsible Person, Eldris can also notify your products on the CPNP, the EU portal for cosmetics.

That filing carries the CPNP filing fee. You choose it at checkout. It is there only when cosmetics are among your products and the market it files into is in your order.

The cosmetics FAQ covers the rest.

Which products have a different representative rule?

Medical devices and in vitro diagnostic medical devices. If the manufacturer is not in a Member State, Article 11(1) of each law applies. The device may then go on the EU market only once the manufacturer names a sole authorised representative.

For medical devices, the rule is Article 11(1) of Regulation (EU) 2017/745. In vitro diagnostic medical devices follow the same rule under Regulation (EU) 2017/746.

These are products covered by their own law. The role each one names is a sole authorised representative. So it is not the Responsible Person of the GPSR.

A product that fits none of the named types goes under Other / not listed. That is the last option on the form.

Whichever law applies, Eldris's terms require you to make sure your products comply with all applicable EU product safety rules. You do that before you place them on the EU market.

After payment you also give Eldris accurate and complete product details in your portal, safety documents included. Check which law covers each product before it goes on sale. That law then decides which operator rule and which label rule apply.

Frequently asked questions

Do I need a separate appointment for each product type?

No: you select every product type you sell, and one registration per market covers all of them. The monthly plan follows your SKU count, not the type, so a new product type does not need a new registration. A seller of cosmetics and other goods also needs only one appointment, because EldrisAi OÜ holds both roles.

Is clothing covered by a Responsible Person?

Clothing and textiles is one of the eight product types the onboarding form lists. Where clothing is among the products covered by the GPSR, Article 16(1) needs an economic operator in the EU to be responsible for it. That operator must be in place before the clothing goes on the EU market.

What if my product is not on the list?

Choose Other / not listed, the last option on the onboarding form, and then check which law covers the product. Products covered by an act listed in Article 4(5) of Regulation (EU) 2019/1020 follow its Article 4. A cosmetic follows the Cosmetics Regulation, and other products covered by the GPSR follow its Article 16.

Can Eldris act for radio equipment, such as a Wi-Fi device?

Yes: radio equipment falls under Directive 2014/53/EU, one of the acts in Article 4(5) of Regulation (EU) 2019/1020. Under Article 4(2)(c), its EU operator can be an authorised representative with a written mandate, and Eldris covers those acts. But you or your test laboratory prepare the Declaration of Conformity, not Eldris.

Do medical devices follow the same rule?

No: a medical device follows its own law. Under Article 11(1) of Regulation (EU) 2017/745, a manufacturer outside the EU must name a sole authorised representative for it. In vitro diagnostic medical devices follow the same rule under Regulation (EU) 2017/746, and that role is not the Responsible Person of the GPSR.