EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

Europaudvalget 2021-22
EUU Alm.del Bilag 536
Offentligt

NOTE

19. maj 2022

Danish comments to public consultation of the revision of the Toy

Safety Directive

The Danish Government welcomes the revision of the Toy Safety Di-

rective. It is important that all toys placed on the EU market are safe and

compliant with the legislation and that the legislation is up to date with

regards to the newest scientific knowledge, new types of toys on the mar-

ket and new ways of selling toys, e.g. through online marketplaces.

Therefore, the revision of the directive is needed and appreciated.

Comments related to the questionnaire

Generic risk approach

The most harmful chemicals, as pointed out in the Chemical Strategy for

Sustainability, shall be banned in toys, as CMR substances are banned in

toys today. The most harmful chemicals that should be automatically

banned in toys include CMR substances, endocrine disrupting substances,

substances affecting the immune, neurological or respiratory systems,

chemicals toxic to specific organs, substances that can cause an allergic

response following skin contact, and PBT’s, vPvB’s, PMT’s and vPvM’s.

An automatic ban of these substances in toys, must be introduced as soon

as possible.

An automatic ban of the most harmful chemicals should be introduced

not only in toys, but also in other consumer products. It is essential that

products children use (e.g. toys) and products for children (e.g. childcare

articles) are handled the same way to ensure a high protection of children.

This could be by either broadening the scope of the Toy Safety Directive

to toys and products for children or by introducing an identical ban in the

REACH Regulation for products for children with the same entry into

force as for toys.

To harmonize the generic risk approach, hazard identification of sub-

stances shall be performed under the CLP Regulation, and it is important

that the CLP Regulation include hazard classes for endocrine disrupting

substances for early identification of those hazardous substances.

Automatic ban of CMR’s, endocrine disrupting substances, substances af-

fecting the immune, neurological or respiratory systems, chemicals toxic

to specific organs and substances that can cause an allergic response fol-

lowing skin contact should be introduced in a toy safety directive/regula-

tion. But also automatic ban of substances that are bioaccumulative as

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

PBT’s and vPvB’s should be introduced in a toy safety directive/regula-

tion, as these substances can be expected to accumulate in humans as well

as in the environment. Automatic ban of PMT and vPvM substances can

be introduced in REACH, as the exposure of the environment from these

substances from toys will be similar to the exposure from other consumer

products.

Derogations to an automatic ban of substances of concern

The Chemical Strategy for Sustainability highlights that the most harmful

chemicals are only allowed, if their use is necessary for health, safety or

is critical for the functioning of society, and if there are no alternatives

that are acceptable from the standpoint of environment and health. Den-

mark supports that derogation to the automatic ban is introduced, if spe-

cific requirements are met. The impacts of the requirements should be as-

sessed and the assessment should include the following:

•

Only trace levels of chemicals of concern are allowed as is the case

for CMR substances in cosmetic products.

•

A scientific committee has assessed the use of the most harmful

chemicals as safe under a specific concentration.

•

The most harmful chemicals are inaccessible.

•

The lack of alternatives.

Denmark is of the opinion that toys, as a product group, is essential for

the society. Every single piece of toy can on the other hand not be seen as

essential. It is therefore important to set requirements for derogations that

makes sure that toy as a product group is not banned due to an automatic

ban on the most harmful chemicals, but to set requirements that ensures

that toys are safe and to the widest extent do not contain substances of

concern. Denmark therefore finds that as a minimum a derogation can

only be given for substances of concern, if an assessment of alternatives

shows that there are no suitable alternatives and if the use of the chemical

has been assessed by a scientific committee and the use is safe under nor-

mal and foreseeable conditions.

Setting specific chemical limit values for toys for children of all ages

Denmark strongly supports the possibility to set limit values for chemi-

cals in toys for children of all ages and not just for toys for children under

the age of 36 months and to toys intended to be put in the mouth.

There have been several examples on toys for children above 36 months

where requirements for chemicals are necessary. An example is preserva-

tives in modeling clay. The preservatives listed in appendix C are skin

sensitizers and these preservatives are restricted in toys for children be-

low 36 months, but not in toys for older children as modelling clay, even

though they are just as sensitizing for older children.

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

Moreover, the Scientific Committee on Health Environment and Emerg-

ing Risks (SCHEER) has concluded in an opinion on chemicals in

squishy toys (https://ec.europa.eu/health/publications/toxicological-refer-

ence-values-certain-organic-chemicals-emitted-squishy-toys-regard-

adopting-limit_en ) that children younger than 6 years old might bite,

chew or suck on the toy with the possibility of a release of substances

into saliva due to migration (see appendix 1.1). The current TSD does not

cover the oral exposure and possible risk of chemicals in toys for children

at 3-6 years old, but only children under the age of 36 months through ap-

pendix C. To protect the children of the age of 3-6 years old as much as

the smaller children, appendix c should be expanded to cover toys for

children up to the age of 6 year.

One way to implement specific chemical limit values could be to intro-

duce one limit value for the specific chemical for children up to 3 years,

another for children between 3-6 years and a third limit value for children

above 6 years old. In this way, it is possible to consider the realistic expo-

sure scenario and thereby achieve a more safe level for all children.

Labelling obligations of chemicals

We support an introduction of labelling requirement for chemicals in toys

that are substances and mixtures and with the possibility to introduce

such a requirement for all other toys at a later stage. Labelling require-

ment would create great value for both consumers, retailers and for au-

thorities:

A Danish survey shows that consumers are concerned about the presence

of harmful chemicals in toys. Furthermore, more than half of the consum-

ers see a need for a labelling of chemicals present in toys. One third of

the consumers from the survey were looking for information regarding

chemicals in toys before buying them, and in many cases, this infor-

mation was not available.

Experience from a Danish retailer (who has implemented a labelling re-

quirement) and its suppliers show that labelling of chemicals will also be

of value for the retailers, as it will lead to greater transparency in relation

to the use of chemicals throughout the entire supply chain. Labelling of

substances will also make it possible for distributors and importers to set

criteria for the content of certain substances and make it relatively easy to

check compliance.

Labelling of chemicals on toys will also be of value for authorities, as it

will provide valuable information about the use of chemicals in a product

group, where this information is not readily available now.

As proposed in this paper under the digital product passport, the infor-

mation of the content of chemicals could be provided in the digital prod-

uct passport, and it should be considered, if the information should be on

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

the product as well. With advantage, possible synergies between these

two initiatives could be considered further.

Data security and cyber security for toys

Data and cyber security requirements are important for products to avoid

risking that personal information and data are leaked via products or that

consumers are exposed to fraud. These challenges are applicable to all in-

ternet-connected products. It is not a specific problem for toys alone.

It is therefore advantageous to place rules regarding data and cyber secu-

rity in more general legislation than to include it in the sector specific leg-

islation for toys and thereby compiling rules for cyber security in RED

and rules for data security in GDPR. If specific

risks for children’s data

and cyber security in toys arise and if these are not considered and ad-

dressed under any other legislation, then it is our opinion that it is im-

portant to include these rules in the revision of the TSD. It is our under-

standing, that the GDPR covers internet-connected toys and when data

processing occur, while RED only covers data containing a radio unit. If

there are cyber security or data security risks not covered by these legisla-

tions, then it must be included in the revision of the Toy Safety Directive.

Potential psychological risks

The Danish Safety Technology Authority has not received any reports re-

garding potential psychological risks of toy products, and we are there-

fore not aware of psychological risk of toys being a widespread problem

in Denmark.

We acknowledge that there can be toys and scenarios where toy products

can have a negative psychological effect on children, whether the use of

the product encourages inappropriate or dangerous behavior or because

the toy can be frightening for children in a certain age group.

If rules regarding psychological risks of toys are implemented in the TSD

it is important that specific frameworks and guidelines are included so

that businesses and market surveillance authorities have a specific start-

ing point for the assessment of such risks. If there is no clear definition

then it will be difficult to control for authorities and for companies to be

compliant. It is important to acknowledge that there will be a demand for

new skills for companies and authorities in order for them to assess the

potential psychological risks of toys, and that these skills only are present

at a minimal level today. There is therefore a need of clear guidelines for

the definition of psychological risks, if these are to be included in the

TSD.

Should the directive be converted to a regulation?

It costs resources for authorities to implement changes from the Toy

Safety Directive into national law, and it can be advantages to convert the

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

directive into a regulation, thereby saving national resources. In Den-

mark, the directive is implemented via the Danish Executive Order, and it

is the assessment of the Danish Safety Technology Authority that a con-

version from directive to regulation only will have a small amount of in-

fluence on the product safety of toys itself. The advantages are therefore

in regards to resources and not for the product safety of toys.

Third party verification of toys

Third-party verification/EU-type certificate is rarely seen on toys in Den-

mark, even on chemicals, where the existing harmonised standards and

the chemical requirements in the directive does not cover all hazards that

chemicals can cause. Depending on the chemical requirements in a new

directive/regulation on toys, it can be considered if third-party verifica-

tion/EU-type certificates should be more commonly used in cases of

chemicals, especially for the emission of chemicals, where no require-

ments exists. Either there need to be more third-party verification/EU-

type certificate of the content/migration/emission of chemicals from toys,

or the chemical safety assessment should show that the toy is safe, which

is not the experience from the Danish Environmental Protection Agency

today.

Today, when companies perform conformity assessments of their toy

products, there is only a requirement of third party verification from a no-

tified body, when the products are not tested after harmonized standards

or if there are potential risks that the harmonized standards does not take

into account. By far, most of toys are today tested after the harmonized

standards on the physical/mechanical aspects, and it is relatively rare that

toys are verified by third parties before they are brought to market.

There is a number of requirements on how to test toys in the harmonized

standards. However, to this day, there are no requirements for the test la-

boratories that perform these tests after the harmonized standards. This

means that there is a potential risk that laboratories without the necessary

skills and knowledge are able to test toys that are brought to market after-

wards. The Danish Safety Technology Authority therefore believe that

there should be requirements for the skills and knowledge of the laborato-

ries that test products by harmonized standards, and that this option will

be able to address the issue more effectively than an expansion of third

party verifications.

Digital Product Passport

Denmark is in favor of the introduction of a digital product passport (as

proposed in the Sustainable Products Initiative) for most products, toys

included, and that information about the product will be accessible for

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

both consumers and authorities in the passport. As such, information con-

cerning e.g. EU-type examination certificates, safety information (includ-

ing the safety assessment), the content of chemicals for toys etc. disclosed

by the responsible company or any notified body would be of value to the

enforcement authorities and some of the information would be of interest

for consumers.

However, it is important to keep in mind that all the information directed

at the consumers should not only be provided digitally. The most im-

portant information should be placed and kept on the toys or the packag-

ing of the toy. It should furthermore be considered if a future labelling re-

quirement of chemicals in toys should be given on the physical product or

digitally or both.

The Danish Safety Technology Authority’s experience is that we in most

instances receive the documentation that we request such as conformity

assessments and third party test rapports when relevant and when re-

quested. Therefore, we cannot conclude that a digital product passport

with the relevant and necessary documentation will heighten the compli-

ance of toy products and companies significantly.

However, it is important to note, that the abovementioned compliance to

document requests does not exist in the case of online platforms. It is sig-

nificantly more difficult to obtain the needed and requested documenta-

tion from online platforms. A digital passport could make the request for

documentation easier for authorities in this instance.

A digital product passport has the potential to further heighten toy safety

for children, as it can create a basis of information on which the consum-

ers can decide whether to buy a product or not.

If a general digital product passport is introduced to almost all products

across sectors through other legislations, such as the Eco-Design for Sus-

tainable Products Regulation, it would be highly efficient and recom-

mendable to require the documentation for the safety of toy products to

be included in the general product passport. This would reduce the

amount of resources for market surveillance authorities in the performing

product controls when requesting and obtaining documentation. If the

right solution is developed, it can potentially also make it easier for com-

panies to provide and display information for consumers and authorities.

The Danish Safety Technology Authority in general encourages stream-

lined requirements for the digital product passport across all harmonized

standards, as it will simplify requirements to the products content to the

benefit of as well the consumer, the companies, and the market surveil-

lance authorities.

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

The market surveillance authorities would benefit from the inclusion of

conformity assessments and of documentation of the

toy products’ safety

compliance in the digital product passport. For toys, this documentation

typically consists of test reports on the physical/mechanical and chemical

tests, where the products are tested after harmonized standards that are

published in the Official Journal.

The existing labelling requirements should also be included in the digital

product passport. We cannot expect that the consumers always have the

necessary means (e.g. smartphone) to access the digital product passport

to when buying toy products in a physical store. The Danish Authorities

therefore believe that warning labels such as age limits, weight limits,

height limits etc., should still physically be placed on the product. It

should be considered whether information about chemicals should be

given physically on the toy or disclosed in the digital product passport

only.

Comments on other issues

Online platforms

Consumer safety should not rely on whether a product is purchased in a

physical store or from an online platform. It is important that sellers from

third countries who sell from online platforms, does not bypass product

safety regulations and requirements for toy products and thereby creating

unfair competition for EU businesses and potential risks for consumers.

The Danish authorities support the demand for online platforms to as-

sume the same responsibilities as importers, when they facilitate sales

from third party countries on the single market.

We do not experience the same issues in obtaining documentation from

traditional web shops, where a company sells their products directly to

consumers, as companies in general are easily classified as ‘manufac-

tures’, ‘importers’ or ‘distributors’, enabling us to treat

them as compa-

nies with physical stores.

Especially in terms of

toys sold online through online marketplaces

traders established outside the EU, the non-compliance with the TSD is

very high

–

and the issue is that the current legislation has no effective

measures to place the liability for the non-compliance on an economic

operator.

It is an issue, that online platforms cannot easily be placed into these cat-

egories defined by current regulations. This means that we cannot effec-

tively hold online platforms

accountable for their products’ compliance to

product safety, and we find it difficult to obtain requested documentation.

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

It is important that online platforms can be held accountable to the same

degree that traditional importers are when they act according to this role.

Online platforms must make sure that their products are compliant with

the rules and requirements in the TSD and other relevant legislation for

toy products, when no other relevant economic operator is available.

We had expected that the Digital Services Act amending Directive

2000/31 (the e-Commerce Directive) would close this legal loophole by

introducing that a liability on an economic operator in the EU existed in

all cases. This would create a level playing field for all economic opera-

tors making products available on the market, it would enable and facili-

tate enforcement by the market surveillance authorities in cases of non-

compliance and it would raise the level of protection for consumers in the

EU. However, the regulation does not introduce such a liability and that

the measures actually introduced are not sufficient to battle the issues of

non-compliant toys sold on online marketplaces. For instance, it remains

to solve the issue of illegal products constantly reappearing online though

they have already at least once been removed.

We believe that any natural or legal person established outside EU that

makes a toy available on the market, should always appoint a person es-

tablished in the EU that is responsible for the compliance of the product

–

and that the online marketplace shall be responsible for the compliance of

the product, if no such person has been appointed. This way the online

marketplace would hold a liability corresponding to its importer-like role

in the product distribution chain. Furthermore, we suggest that for online

marketplaces established outside the EU, the legal representative that is to

be appointed according to the DSA, should be liable for the non-compli-

ance with obligations under this regulation, i.e. if the online marketplace

does not live up to its responsibility.

Another thing is the increasing emergence of so-called

“pop-up” compa-

nies, i.e. companies that are only in business for a short while, usually in

order to benefit from the access to the market without having to face pos-

sible legal consequences of non-compliance. This issue of these cases of

“voluntary bankruptcy” is of more horizontal character, but still we be-

lieve that it is an issue that should be held in mind when revising the

chemicals legislation, including the TSD. A possible way forward could

be introducing a liability rule, similar to the one proposed in regards to

online marketplaces, that ensures that the responsibility for the compli-

ance of a product can always be placed on a

solvent

economic operator

established in the EU.

Finally, on a more general level we note that enforcement measures

should promote smooth interplay of knowledge and procedures between

customs authorities and market surveillance authorities. Under the

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

REACH Regulation it is being proposed to embed the Authorised Eco-

nomic Operator and to develop an EU-wide TARIC list of high-risk prod-

ucts. Similar measures could with benefit be considered under the revi-

sion of the TSD in coordination with DG TAUX. Furthermore, it is im-

portant that control procedures are the same regardless of the “Port of en-

try” which is chosen in a specific case, so that an economic operator can-

not benefit from choosing one port of entry instead of the other.

Combined exposure of chemicals

–

introduction of a Mixture Assessment

Factor

During the course of a day, a child typically uses a wide range of toys and

other products. Hence, the probability of exposure to substances with the

same mechanism of action from various products is substantial. Cur-

rently, specific chemical limit values for toys are evaluated as substance-

by-substance, when specific chemical limit values are established.

Thereby the exposure from other substances with the same mechanism of

action are not taken into account. To ensure that children are consistently

protected, and there are no risk for children’s safety, the combined expo-

sure should be included in the evaluation and safety assessment. One pos-

sible method for doing this is by introducing a Mixture Assessment Fac-

tor (MAF). A MAF addressing co-exposure from unknown unintentional

mixtures should be introduced as soon as possible.

We have commented in the targeted survey launched by the consultants

providing input to the Commissions planned impact assessment with sup-

port for introducing a single MAF addressing both human health and the

environment with a factor of 10 for all registered substances. It is long

overdue to address the issues with combination effects of chemicals and

the need for action was announced more than 10 years ago in both Coun-

cil Conclusions (17820/09) and in a message from the Commission to the

Council and Parliament (COM(2012) 252 final).

Chemical safety assessments and requirements for toy safety assessors

According to the current TSD, manufacturers must prepare a safety as-

sessment, including a chemical safety assessment, as part of the technical

documentation. It is mandatory to perform a safety assessments for all

toys and the assessments shall cover all relevant aspects to ensure the

safety of human health.

As given from the article (art. 18), the manufacturers shall, before placing

a toy on the market, carry out an analysis of the chemical (…) hazards

that the toy may present, as well as an assessment of the potential expo-

sure to such hazards.

Experience has shown that the chemical safety assessments, that has been

requested, quite often are unavailable or deficient to a varying degree. It

is the overall experience that an analysis of the chemical hazards has not

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

been done, and that the manufacturer uncritically analyse after the stand-

ard EN 71-3. Therefore, toys are generally not assessed for the chemical

hazards that the specific toy might possess as is the goal of the chemical

safety assessment. As a result of this, any assessment of the potential ex-

posure to the hazards has not been done either.

It is also the overall experience that guidance and instruction from the au-

thority in the attempt to correct the evidently huge issue of deficient or

lacking safety assessments are scarcely fruitful. Any attempt of correction

of the safety assessment performed by the manufacturer often result in the

fact that the corrected safety assessment cannot be accepted either.

In dialogue with the Danish Toy Industry, it is made clear that the guid-

ance document on technical documentation is not sufficient as a guiding

tool, and the industry in general has not sufficient knowledge on how the

safety assessments with regards to the chemical aspects should be per-

formed.

Therefore, we strongly recommend to make it more clear how the safety

assessment for the chemical aspects should be carried out. Firstly, it

should be specified in the regulation that the assessment of chemicals

should take into account the general toxicological profile of the ingredi-

ents, their chemical structure and their level of exposure. Secondly, a ge-

neric template should be developed as the one implemented in the Cos-

metics Regulation, Annex I . As a minimum of obligations and require-

ments that should be considered included in the template are the follow-

ing elements:

Unique number to identify the toy.

•

Information on manufacturer and/or importer.

•

Bill of materials (BOM); List of raw materials, intermediates and

components used to manufacture the final toy, stating the quantities

used.

•

Bill of substances (BOS); List of chemical substances in each mate-

rial and where the chemical is in the product, stating the substance

CAS numbers and the concentrations in which the substances are pre-

sent.

•

Safety Data Sheet (SDS); Safety data sheets for chemicals used in the

manufacturing process if required under REACH Regulation.

•

Test reports when relevant; Results of chemical analyses document-

ing that the toy complies with relevant regulation, but also name and

address of the laboratory performing the test.

•

Hazard characterization of the substances listed in BOS.

•

Exposure scenario that includes all routes of exposure to all the chem-

icals in the toy.

•

Risk assessment carried out in accordance to updated EU-guidance.

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

To support the template in a new toy directive/regulation, a new guidance

document should be developed. The Danish authority has in collaboration

with the Danish Toy Industry made a guidance document to support the

industry in how to carry out the chemical safety assessment, but also how

the importer and distributors could prepare the dialogue with the suppli-

ers. This is available in both Danish and English and it (or a shorter ver-

sion) could be used as an supporting guidance document. Besides the def-

inition, template and guidance on chemical safety assessments of toys, we

also recommend that the new TSD is setting minimum requirements for

the safety assessors and their qualifications. To carry out a chemical

safety assessment, it is crucial that the assessment is carried out by a per-

son in possession of the necessary qualifications. It necessary, but also

appropriate, to require, that the chemical safety assessment shall be car-

ried out by a person in possession of a diploma or other evidence of for-

mal qualifications awarded on completion of a university course of theo-

retical and practical study in pharmacy or toxicology, chemistry and theo-

retical and practical knowledge on chemical risk assessment.

Transitional periods for new chemical requirements

The ‘Blue Guide’ on the implementation of EU products rules 2016

(2016/C 272/01) states that “The placing on the market is the most deci-

sive point in time concerning the application of the Union harmonised

legislation” and that “Compliant products once they

have been placed on

the market may subsequently be made available along the delivery chain

without additional considerations, even in case of revisions to the applica-

ble legislation or the relevant harmonised standards, unless otherwise

specified in the

legislation.” This guidance text applies unless otherwise

specified in the product legislation concerned.

Today, when new requirements for chemicals in toys are introduced,

there is no specification of whether and how long toys containing the

banned chemicals can be made available on the market. This means that

the principle above applies, i.e. that a toy containing banned chemical

substances can be made available on the EU market for many years, if the

toy at the time of the placing on the market was compliant with the legis-

lation.

This creates an unnecessary exposure for children of chemicals that might

be harmful. Furthermore, in practice, this state of law is also almost im-

possible to enforce by the market surveillance authorities, since any en-

forcement measure in this regard requires information on exactly when

the product was made available on the market for the first time i.e. the

time of the placing on the market in order to determine which legislation

applied at that time. When performing market surveillance activities such

as the power to carry out unannounced on-site inspections and physical

checks of products cf. article 14 (4), litra d in Regulation 2019/1020 , the

EUU, Alm.del - 2021-22 - Bilag 536: Regeringens høringssvar til Kommissionens vedr. høring om revision af legetøjsdirektivet

information on the time of the placing on the market is rarely available to

the market surveillance authorities.

To overcome the issues above, we suggest that transitional periods for the

making available on the market of toys containing banned chemicals are

being inserted in a directive/regulation. Such transitional periods are used

under other product legislations, e.g. the Cosmetics Regulation, and are

known to be workable for both industry and market surveillance authori-

ties. The length of the transitional period can vary depending on the avail-

ability of alternatives.