The obligations of the importer of the mixture depend on the interpretation of each specific entry in Annex XVII to REACH for the substance concerned, taking account of the wording, the context and the purpose of the restriction in question.

For instance, if a substance were completely banned, then it could not be placed on the market, not even as an impurity in a substance in an imported mixture. On the other hand, some Annex XVII entries specify limits above which a substance cannot be placed on the market. This limit may not be exceeded, no matter what is the source of the substance in the mixture. However, this can only be determined on a case-by-case basis depending on the substance, the restriction and the concentration of the substance as an impurity in the imported mixture.

It should be noted that the impurity may be permissible at any concentration if the use of the imported mixture is not covered in the ‘conditions of restriction' listed in Annex XVII for the substance.

In special cases where, due to the size or shape of the packaging, it is technically not possible to include the protective gloves inside the packaging, it is considered to be sufficient that the gloves are fixed tightly to the packaging in a manner that they cannot be unintentionally removed during handling and transport. The gloves must not obstruct the label and the removal of the gloves must not destroy the label. In addition, both the packaging containing the mixture and the protective gloves must be placed on the market as a single unit, which explicitly signals to the consumer that the mixture may only be used with the protective gloves .

In general, the answer is yes. However, it should be assessed on a case-by-case basis whether the new legal act replaces the repealed one for the purpose of the REACH restriction, taking into account, for example, the objective of the reference. 
The new legal act may explicitly state that references to the repealed act must be construed as references to the new legal act (e.g., Article 139 of REACH).
For example:

• Entry 19 (paragraph 4) exempts certain uses of arsenic compounds for wood preservation if they are authorised in accordance with Directive 98/8/EC. This Directive was replaced by Regulation (EU) 528/2012, which explicitly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 96).
• Entry 45 (paragraph 3) exempts electrical and electronic equipment within the scope of Directive 2002/95/EC from the restriction of diphenylether, octabromo, derivative. This Directive was replaced by Directive 2011/65/EU, which explicitly states that references to the repealed Directive must be interpreted as reference to the new directive (Article 26).
• Entry 50 (paragraph 3) defines tyres covered by the PAH restriction as tyres for vehicles covered by three directives, including Directive 2002/24/EC. This Directive was replaced by Regulation (EU) 168/2013, which expressly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 81).

As regards the amendment of an act referred to in a restriction, references in acts of Union law are usually ‘dynamic’, so that the reference is taken to be to the latest version of the act referred to. However, less commonly, a reference may expressly refer to an act as it stands on a specific date; this is known as a ‘static’ reference.

Article 31(6) of the REACH Regulation provides that the safety data sheet (SDS) shall contain a Section 15 entitled ‘regulatory information’. Annex II to REACH provides requirements for the compilation of the SDS. Section 15(1) specifically mentions that, if the substance or mixture covered by the SDS is the subject of specific provisions in relation to the protection of human health or the environment at Union level (e.g. restrictions under Title VIII), these provisions must be mentioned, unless this information is already mentioned in other parts of the SDS. Thus, all restriction entries applicable to the specific substance or mixture covered by the SDS need to be indicated therein. As an example, SDSs including carcinogenic, mutagenic or toxic to reproduction substances (as such or in a mixture) listed in appendices 1 to 6 to REACH, need to refer to entries 28, 29 or 30 of Annex XVII. If another specific restriction exists for these substances, this needs to be mentioned as well in the SDS.

Moreover, Article 31(9) of the REACH Regulation requires suppliers to update the SDS without delay once a restriction has been imposed. In Section 16 (other information), a clear indication of where changes to the previous version have been made needs to be included, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes.

Article 3(23) of the REACH Regulation defines scientific research and development as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year”.
To further clarify the exemption (within Article 67(1) of the REACH Regulation, manufacture, placing on the market or use of a substance in scientific research and development (SRD) is exempted for restrictions), note that under the authorisation process the following Q&As (concerning the exemption in Article 56 for the use of Annex XIV substances in scientific research and development) has been provided. The same approach can be broadly considered as applicable to restrictions.

• Q&A 1153 states that sampling for further analysis is not exempted and thus not regarded as scientific research and development. However, “activities considered to form part of the use of the sample in performing analytical activities” fall within the exemption. 
• Q&A 1030 explains that the uses of a substance upstream preceding an exempted end-use in scientific research and development are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to certain conditions. 
• Q&A 585 explains that the exemption from authorisation also applies to the use of a substance in analytical activities such as monitoring and quality control under certain conditions. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities, but does not cover sampling activities.

Scientific experimentation, analysis or chemical research in universities and secondary schools, conducted by students, may fall within the exemption, if they are carried out under controlled conditions, in a volume less than one tonne per year. In other words, if the volume of a substance used in scientific experimentation, analysis or chemical research is less than one tonne per year and it is used under controlled conditions, restrictions do not apply to that use. 

Many entries in the Restriction List (Annex XVII) cover articles. Such entries are, for instance, entries 50 - 52, 61 and 63. These may address types of textiles and leather articles, even if these are not explicitly mentioned.
The following entries in the Restriction List (Annex XVII) are specific to textiles: 
Entry 4 ((2,3 dibromopropyl) phosphate, CAS No 126-72-7);
Entry 7 (Tris(aziridinyl)phosphinoxide, CAS No 545-55-1; EC No 208-892-5) and 
Entry 8 (Polybromobiphenyls; Polybrominated biphenyls (PBB), CAS No 59536-65-1).
These entries state that these substances “Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.” 
The following entries in the Restriction List (Annex XVII) restrict substances in relation to textiles and/or leather articles:
Entry 18, restriction on mercury compounds in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;
Entry 20 (paragraph 6), restriction on dioctyltin (DOT) compounds in textile articles intended to come into contact with the skin;
Entry 23 (paragraph 6), restriction on cadmium and its compounds in textiles and clothing; 
Entry 43, restriction on azocolourants and azodyes in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity (indicative list is provided);
Entry 46 (paragraph 3) restriction on nonylphenol and nonylphenol ethoxylates in textiles and leather processing (with some exceptions);
Entry 46a, restriction on nonylphenol ethoxylates in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, and
Entry 47 (paragraphs 5-7), restriction on chromium VI compounds in leather articles coming into contact with the skin.

Many entries in the Restriction List (Annex XVII) cover specific articles or all articles without explicitly referring to electrical and electronic equipment. These are, for example, entries 18a, 20, 23-26, 50-52. They may apply to electrical and electronic equipment, even if these are not explicitly mentioned (or derogated) in the entry.
The following entries of the Restriction List (Annex XVII) specifically include a derogation for electrical and electronic equipment: 
Entry 45 (paragraph 3) provides a derogation from the restriction on diphenylether, octabromo derivative (C12H2Br8O) for electrical and electronic equipment within the scope of Directive 2002/95/EC, which has been replaced by Directive 2011/65/EU (on the restriction of the use of certain hazardous substances in electrical and electronic equipment),  and
Entry 63 (paragraph 8) excludes articles within the scope of Directive 2011/65/EU from the restriction on lead and its compounds in articles supplied to the general public.

Many entries in the Restriction List (Annex XVII) cover substances and mixtures in general, without specifying product types. They may thus also apply to paints/paint strippers, even if these are not explicitly mentioned in the entry.
In addition, the following entries in the Restriction List (Annex XVII) explicitly restrict the placing on the market of paints and/or paint strippers: 
Entry 16, restriction on certain lead carbonates in substances or mixtures intended for use as paint;
Entry 17, restriction on certain lead sulphates in substances or mixtures intended for use as paint;
Entry 20, restriction of organostannic compounds acting as biocide in free association paint;
Entry 20 (paragraph 5), restriction on dibutyltin (DBT) compounds in paints and coatings; 
Entry 23 (paragraph 2), restriction on cadmium and its compounds in paints with codes [3208] and [3209] and in painted articles; 
Entries 28-30 (paragraph 1), restriction on CMRs as substances, as constituents of other substances or in mixtures (including paints), for supply to the general public; (paragraph 2) derogation for artists’ paints covered by Regulation (EC) No 1272/2008;
Entry 48, restriction on toluene (CAS No 108-88-3; EC No 203-625-9) in spray paints intended for supply to the general public; 
Entry 54, restriction on (2-(2-methoxyethoxy)ethanol (DEGME) (CAS No 111-77-3; EC No 203-906-6) for supply to the general public, as a constituent of paints and paint strippers;
Entry 55, restriction on 2-(2-butoxyethoxy)ethanol (DEGBE) (CAS No 112-34-5; EC No 203-961-6) for supply to the general public, as a constituent of paints and paint strippers and in spray paints and
Entry 59, restriction on dichloromethane in paint strippers under certain conditions.

In general, cleaning refers to any removal of dirt or pollution from articles or places, both in industrial and institutional facilities as well as in households. 

In some entries cleaning may be specified by reference to a particular user group(s) or potential exposure pattern to which the restriction applies. For example, column 2, paragraph 1 of entries 32-38 refer to the substance or mixture being intended for supply to the general public and/or intended for diffusive applications where releases can occur from multiple sources such as surface cleaning and cleaning of fabrics. Column 2, paragraph 1 of entry 46 applies to industrial and institutional cleaning systems (e.g. in schools, hospitals), with the exception of dry cleaning done in a controlled closed system where the washing liquid is recycled or incinerated and other cleaning systems where special treatment is used with recycling or incineration of the washing liquid. Column 2, paragraph 2 entry 46 applies to all domestic cleaning.

The restriction should be understood as a broad restriction covering all articles that contain liquids specified in the entry and intended to produce light or colour effects by means of different phases and which have an ornamental design. It does not matter if the article also has other functions besides being decorative. So for example, if articles such as cell phone covers, liquid timers, toothbrushes, shower curtains, key-rings and hourglasses contain ornamental features that produce light or colour effects, they are covered by the restriction even though the ornamental function is not the primary function of the article. Decorative LED lamps with glitter are also included within the scope of this restriction.

All polybrominated biphenyls (also referred to as polybromobiphenyls) are covered by the restriction in entry 8. The CAS number referred to in entry 8 is only an example of one of the main commercially used fire retardant products at the time of the adoption of the restriction. 

The REACH Regulation does not provide a specific definition for paints.
According to a general meaning, paint is a mixture, usually of a liquid with a solid pigment. Furthermore, Commission Decision 2009/544/EC (establishing the ecological criteria for the EU Ecolabel to indoor paints and varnishes) provides  the following definition: 'Paint' means a pigmented coating material, in liquid or in paste or powder form, which when applied to a substrate, forms an opaque film having protective, decorative or specific technical properties.
The abovementioned definitions provide an indication of what could be generally considered as a paint in the context of entries 16-17 of Annex XVII (to REACH) provisions.

It should be noted that the restrictions in entries 16-17 of Annex XVII only allow Member States to permit the use of paints containing the restricted substances for the restoration and maintenance of works of art and historic buildings and their interiors. Thus children's paint sets and other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts must not contain the restricted substances.

Concerning children's paint sets, these may also be covered by the Toys Directive (Directive 2009/48/EC on the safety of Toys), which lays down limits for the presence of lead in toys.

The REACH Regulation does not provide a definition of measuring devices (often referred to as measuring instruments). However, in the context of entry 18(a), it has to be noted that:

1. The restriction provision in paragraph 1 of entry 18(a) covers those measuring devices that are intended for sale to the general public and provides an indicative list of these (thermometers, manometers, barometers, sphygmomanometers etc.)
2. Furthermore paragraphs 5 and 7 provide exhaustive lists of mercury-containing measuring devices intended for industrial and professional uses which have not been allowed to be placed on the market after 10 April 2014 (barometers; hygrometers; manometers; sphygmomanometers; strain gauges to be used with plethysmographs; tensiometers; thermometers and other non-electrical thermometric application; mercury pycnometers; mercury metering devices for determination of the softening point; mercury triple point cells other than those used for the calibration of platinum resistance thermometers).

For the purposes of Directive 2004/22/EC on measuring instruments, ‘measuring instrument' means any device or system with a measurement function that is covered by Articles 1 and 3. According to the European Standardisation organisation-CEN, "measuring instruments allow for testing the accuracy and calibration of measuring devices (e.g. water meters, gas meters, electricity meters, etc.)". (http://www.cencenelec.eu/standards/sectors/mid/pages/default.aspx)

The abovementioned definitions provide an indication of what could generally be considered as a measuring device in the context of entry 18(a) of Annex XVII to REACH provisions.

Paragraph 4b) of Annex XVII to REACH concerning arsenic compounds provides for a list of applications for which wood treated with CCA may be used. This is not a list of examples of possible uses but an exhaustive list of authorised applications. It flows both from the actual wording of those provisions and from their objective that the derogation provided for in paragraph 4 must necessarily be subject to a strict interpretation, as confirmed by the Court of Justice (case C-358/11, pp. 40-43).

Consequently, wood treated with CCA cannot be used for other applications than the ones listed in paragraph 4 b). Wood treated with CCA can, therefore, not be used for railway sleepers installed above ground.

Organostannic compounds covered by entry 20 in Annex XVII to REACH, must contain a carbon-tin bond. Substances like tin salts or organotin compounds, for which tin is bound to an atom other than carbon (for example hexanoic acid, 2-ethyl-, tin(2+) salt (CAS-No. 301-10-0)) are not covered by entry 20 in Annex XVII to REACH.

(a) Yes, they do. Entry 20 in the Restriction List (Annex XVII) to REACH imposes DOT compounds restrictions for childcare articles, which are not toys. The REACH Regulation does not contain a definition of toys. The definition of toys in Directive 2009/48/EC on the Safety of Toys is illustrative in determining what should be considered as a “toy” in the context of this restriction (see Q&A 0982).

However, paragraph 6(a) of entry 20 restricts DOT compounds in textile toys as in any other textile article intended to come into contact with the skin. Furthermore, organic tin (including DOT) in toys is restricted by paragraph 13 of Part III (Chemical Properties) of Annex II to Directive 2009/48/EC on the safety of toys, which specifies maximum migration limits.

(b) and (c)

In addition to derogation in paragraph 5(d), the other derogations currently applicable to TBT, DBT and DOT compounds in articles relate to the continued placing on the market of articles that were already in use in the EU before the 1 July 2010 for TBT (paragraph 4(b), before the 1 January 2012 (paragraph 5(b)) for DBT and before the 1 January 2012 for DOT (paragraph 6(b)).

Yes. Packaging can be considered as an article (or a product composed of different articles) in its own right. More information can be found in the ECHA guidance on requirements for substances in articles available at https://echa.europa.eu/guidance-documents/guidance-on-reach (in particular in chapter 2). 

Therefore, with regard to entry 20, packaging should comply with the restrictions for tri-substituted (TBT, TPT) and dibutyltin (DBT) compounds. The restriction of dioctyltin compounds (DOT) which applies only to certain listed articles for the general public, applies to textile packaging.

With reference to paragraph 10 of the Annex to Commission Regulation (EU) 494/2011 amending entry 23 of Annex XVII of the REACH Regulation (cadmium) the concentration threshold of cadmium applies in each metal part of jewellery. The wording used by the legislator, i.e. "metal parts of the jewellery and imitation jewellery" implies that each metal part is relevant; therefore in order to determine if the restriction applies the calculation of the concentration in this case is to be done for each metal part. Therefore, if there are several metal layers as coatings on the surface of an inner (metallic) part of the jewellery these should be regarded as integral part of the metal part and the concentration limit of 0,01% is calculated for this whole metal part. In case the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, each of them should comply with the concentration limit.

The prohibition of the placing on the market of jewellery and imitation jewellery articles containing cadmium includes sales from the manufacturers to distributors and from distributors to retailers, as well as imports. However, Commission Regulation (EU) 494/2011 contains derogation for articles that were placed on the market before 10 December 2011 (for the date see corrigendum published in OJ L 136/105). This means that jewellery and imitation jewellery articles placed on the market for the first time before 10 December 2011 do not need to comply with the prohibition thus they can be sold following entry into force of the new restriction for example to a retailer or on the second-hand market.

Paragraph 8 of entry 23 of Annex XVII to the REACH Regulation states that cadmium and its compounds shall not be used in brazing fillers in a concentration equal to or greater than 0,01 % by weight. In addition, brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. The paragraph also states that brazing shall mean a joining technique using alloys and undertaken at a temperature above 450°C. In accordance with the following paragraph 9, by way of derogation paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications nor to brazing fillers used for safety reasons.

The safety aspect in relation to this derogation is if the use of cadmium containing brazing filler may prevent accidents causing human suffering or environmental pollution.

For the enforcement purposes examples of applications are given. It can be considered that the derogation on uses of cadmium containing brazing fillers for safety reasons in paragraph 9 of entry 23 covers the current uses, such as:

Other applications that would like to benefit from the derogation need to show the similar kind of safety aspects as described above.

Such considerations should take into account the availability on the market of cadmium-free brazing fillers which can address the safety aspects of the specific application of the brazing fillers in an equivalent manner.

See also ECHA´s report "The use of brazing fillers containing cadmium for safety reasons" [PDF].

Paragraph 1 of entry 23 of Annex XVII to the REACH Regulation provides a restriction on cadmium and its compounds in mixtures and articles produced from certain synthetic organic materials (plastic materials) and paragraph 2 provides a restriction on cadmium and its compounds in paints (Tariff codes 3208 and 3209). The following paragraph 3 states that by way of derogation the restrictions in paragraphs 1 and 2 do not apply to articles coloured with mixtures containing cadmium for safety reasons.

There are two safety aspects in relation to this derogation. The first relates to the use of a specific colour or pigment with certain properties which is necessary to prevent accidents. The second relates to the use of a specific colour or pigment with certain properties in safety equipment.

For the enforcement purposes example of applications are given. Based on above, it can be considered that the derogation in paragraph 3 of entry 23 covers current applications of articles such as:

The other applications that would like to benefit from the derogation need to show the similar kind of safety aspects than described above.

Such considerations should take into account the availability on the market of alternative substances which can address the safety aspects of the specific application in an equivalent manner.

See also ECHA´s report "The use of cadmium and its compounds in articles coloured for safety reasons" [PDF].

Entry 23 (paragraph 10 (i)) of Annex XVII to the REACH Regulation states that cadmium and its compounds must not be used or placed on the market if the concentration of cadmium is equal to or greater than 0,01 % by weight of the metal in metal beads and other metal components for jewellery making (see Q&A, 158). In addition, it should be noted that articles produced from plastic material referred to in paragraph 1 of the entry must not be placed on the market if the concentration of cadmium is equal to or greater than 0.01 % by weight of the plastic material.

Thus, in the case of plastic coated metal beads (CCB beads), both the plastic material and the metallic part of the bead need to comply with entry 23 (cadmium restriction).

Please also note that if the article is painted, then paragraph 2 will also apply to this article.

No. They cover only plated metal parts. Paragraphs 5 and 6 of entry 23 prohibit the use of cadmium for “cadmium plating” (defined as a deposit or coating on a metallic surface with metallic cadmium) metallic articles used in specified sectors/applications. The placing on the market of cadmium-plated articles used in those sectors/applications and of articles manufactured in some of those sectors/applications is also prohibited. The latter reference to “articles manufactured” must be taken to mean articles that have been cadmium plated, since paragraphs 5 and 6 relate only to “cadmium plating”. Accordingly, Paragraphs 5 and 6 do not cover articles with metal parts containing cadmium unless these parts are plated with cadmium. 
Note that metallic articles containing cadmium may be covered under other EU legislation. For example, (1) electrical and electronic equipment falls under Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances and must comply as well with the maximum concentration limits for cadmium set in that Directive and (2) toys are covered under Directive 2009/48/EC on the Safety of Toys.

No. Ink is not included in the TARIC codes [3208] [3209] which define the scope of paragraph 2 of entry 23. 

Entry 27 of Annex XVII to REACH states that nickel may not be used "in articles intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5 Jg/cm²/week". The aim of this restriction to protect consumers against nickel allergy which may be caused by prolonged contact of the skin with nickel-releasing articles that come into direct and prolonged contact with the skin such as jewellery, buttons, tighteners, zips and rivets in items of clothing. It has emerged that some mobile telephones contain nickel in surface material and that consumers are at risk of developing eczema through skin contact with the mobile telephone. As mobile telephones are clearly intended to come into direct contact with the skin, and as they are used on a daily basis often for prolonged periods of time, it is considered that mobile telephones fulfil the condition of "direct and prolonged contact with the skin". Therefore mobile telephones are covered by the restriction and should comply with the conditions set in Entry 27 of Annex XVII to REACH.

Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than

• 10 minutes on three or more occasions within two weeks, or
• 30 minutes on one or more occasions within two weeks.

The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two-week time period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period.

Details

 

 

Substances within the scope of entries 28-30 are not allowed to be placed on the market or used for supply to the general public as substances, as constituents of other substances or in mixtures when the concentration is equal to or greater than the specified limits. Certain derogations apply to this restriction as listed in paragraph 2. CMR substances that are present in articles are not within the scope of the restriction imposed by entries 28-30, but other restrictions may be applicable to these substances, when present in articles. In addition, notification and communication obligations under REACH may apply; see the ECHA website: https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.

It should be noted that entries 28 and 29 are applicable to the substances that are listed in Appendices 1 & 2 (carcinogenic (C), categories 1A and 1B) and Appendices 3 & 4 (mutagenic (M), categories 1A and 1B). Entry 30 is applicable to substances which are classified as reproductive toxicants (R), categories 1A and 1B and listed in Appendices 5 and 6. These Appendices are regularly updated by including new substances, after the adoption of a harmonised classification for a substance as CMR, category 1A or 1B according to Regulation (EC) No 1272/2008.   

The REACH Regulation does not define aerosols or aerosol dispensers.
According to the ordinary meaning of the word, an aerosol is considered to be "a substance enclosed under pressure and released as a fine spray by means of a propellant gas". (Oxford advanced dictionary definition). The term may in certain contexts be used for a mixture enclosed under pressure and released as a fine spray by means of a propellant gas, or the dispenser or package used to change the ingredient inside the container into a spray by the use of a propellant gas. The European Aerosol Federation uses the term "aerosol" for both the suspension and the dispenser/package.

Furthermore, it should be noted that according to Article 2.3.1 of the CLP Regulation (for "Classification, Labelling and Packaging"), the term "aerosol dispenser" means: any non-reusable container made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state.

The CLP definition is very similar to the definition provided in Article 2 of the Aerosol Dispensers Directive (ADD) (75/324/EEC).
The above definitions provide an indication of what could be generally considered as ‘aerosols/aerosol dispensers' in the context of Entry 40 of Annex XVII. Note that aerosol generators should be regarded as aerosol dispensers, as the original restriction discusses aerosol generators.

Entry 40 prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes". Paragraph 1 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used to decorate, for instance, venues for festivities (e.g. Christmas, weddings, and carnivals) or parties (e.g. birthday parties and fancy-dress parties) and for entertainment use, for instance, during festivities and parties. None of the examples listed in the entry are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.

Coloured hair sprays and body glitter would fall within the definition of cosmetic products in Regulation (EC) No 1223/2009, as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance" and therefore have a similar use to more classical cosmetic products, such as normal hair sprays. Coloured hair sprays and body glitter should not be considered as having an entertainment or decorative purpose, and therefore they are not covered by entry 40 of Annex XVII to REACH.

Through a literature search and consultation with experts in this area it was not found any structural connection between optical brighteners (or better called fluorescent dyes) and azodyes since either the NH bonds in the fluorescent dyes are connected to heterocyclic NC structures and therefore cannot form any of the 22 banned arylamines or they do not contain any azo bonds where reductive cleavage could take place to generate any of the aromatic amines covered by the azodyes ban. Therefore at the present time, this information confirms that the restriction in Entry 43 to Annex XVII does not cover optical brightening agents (OBAs). Should the chemical structure of optical brightening agents be different from the definition as reported above, this answer may change accordingly.

Entry 43(3) of Annex XVII restricts the placing on the market of substances and mixtures containing over 0.1% of the azodyes listed in Appendix 9, when they are intended for colouring textile and leather articles, and also the actual use of the substance or mixture for that purpose. Therefore, the presence of these substances in imported articles is not restricted.

However, pursuant to paragraphs 1 and 2 of the restriction, if an azodye in Appendix 9 releases one or more of the aromatic amines listed in Appendix 8 in a concentration above 30 mg/kg (0,003 % by weight, it cannot be used in textile and leather articles which may come into direct and prolonged contact with human skin or the oral cavity (such as those listed in paragraph 1). Those textile and leather articles cannot be placed on the market unless they comply with that concentration limit.

No. The use of the words “such as” makes clear that the list of items mentioned in paragraph 1 of entry 43 of Annex XVII to REACH is a non-exhaustive list of examples of items covered by this restriction (clothing, footwear, textile toys etc.). 

Yes. Garden furniture made of textile or leather is covered by entry 43 as people who use them can be in light clothing (even in bathing suits or bare) and “direct and prolonged contact with human skin” is very likely. There is even a direct reference to chair covers in the list of examples of articles covered by the restriction. 

Yes. The intention of the legislator was to cover all isomers, linear and branched, of nonylphenol and their ethoxylates and therefore all of them are covered by the restriction.

The restriction on nonylphenol and nonylphenol ethoxylates was based on the risks identified in the risk assessment report prepared by the United Kingdom under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. The risk assessment report states that "It is understood that nonylphenol (CAS Number: 25154-52-3) as originally defined by CAS (Chemical Abstract Service) covered all nonylphenols. However, subsequent revisions redefined it to cover only straight chain nonylphenol, other isomers having different CAS numbers. Given the method of manufacture of nonylphenols, very little if any straight chain nonylphenol is produced. That which is produced is only likely to be present at very low levels in commercial mixtures. The commercially produced nonylphenols are predominantly 4-nonylphenol with a varied and undefined degree of branching in the alkyl group. This assessment covers commercially produced material (predominantly 4-nonylphenol, branched). This material will also contain smaller amounts of other isomers and impurities, and falls under the CAS Number 84852-15-3."

Therefore Council Directive 76/769/EEC, as amended by Directive 2003/53/EC, did not specify any CAS or EC numbers for nonylphenol. In the revision of the REACH restriction by Regulation 552/2009/EC, which made several technical changes, the CAS and EC numbers were added. This will be corrected by a technical amendment to reflect the intention of the legislator.

Paragraphs (1) to (9) of entry 46 list the ‘purposes' to which the restriction applies. Following paragraph (7) "cosmetic products" is paragraph (8) "other personal care products". It therefore seems that cosmetics are to be considered as a subcategory of personal care products.

REACH does not define "cosmetic products". According to Regulation (EC) No 1223/2009 on cosmetic products,  "cosmetic product" means "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance protecting them, keeping them in good condition or correcting body odours."

Based on the above, it can be interpreted that "other personal care products" within the meaning of entry 46 include, but are not limited to, any product meeting the conditions indicated in the above definition for substances and mixtures and other products used for personal hygiene, such as toilet papers, some female hygiene products, nappies, cotton pads, etc. This interpretation can be broadly considered as a perception of the average consumer for this product category. 

Entry 48 prohibits the placing on the market for supply to the general public of toluene as a substance or in mixtures, in a concentration equal to or greater than 0.1% by weight, where the substance or the mixture is used in adhesives and spray paints. Adhesive tapes consist of a layer of adhesive coated on a flexible substrate. As the restriction concerns the concentration of toluene in adhesives, the concentration of toluene must be calculated with reference to the amount of adhesive on the tape, and not with reference to the total weight of the adhesive and substrate.

As stated in Recital 8 of the Directive 2005/69/EC (OJ L323, 9.12.2005, p.51), there are at present no harmonized test methods for measuring PAHs in the extender oils, or for measuring PAHs in tyres that contain such oils. Until suitable harmonized methods are available, the only named method that is permitted for measuring the PAH content of extender oils is the IP346 analysis method. This method is permitted providing that certain additional conditions are met. These additional conditions are necessary because the IP346 method does not measure the PAH content directly. In fact IP346 measures the total content of polycyclic aromatic compounds (PCA) rather than the PAH content. The PCAs are a group of substances to which PAHs belong, but in which PAHs are present in only very small amounts. The legal limit for PAHs in extender oils, which is 1 part per million (ppm) of BaP and 10ppm total PAH content, is considered to be met if the total PCA content is <3%. In other words, the PCA content of 3% is taken as a proxy measurement for a PAH content of 10ppm. The proxy measurements will be valid only if the ratio between the PAH and PCA content in the extender oil is known and does not change over time. The additional conditions therefore require an initial calibration of the technique (measurement of the PAH/PCA ratio) and recalibration at intervals of six months, or after "major operational change", in order to ensure that the measurements remain valid over time. The term "major operational change" should therefore be taken to mean any change in materials or processes that could invalidate the results of the proxy measurement. The principle cause of invalid results would be a change in the PAH/PCA ratio in the extender oil. However, it should be remembered that not only is IP346 a proxy method for measuring PAH, but that the quantity that it does measure, namely PCA content, is meaaured in a rather indirect way, namely by a change in the refractive index of a solution, and that PCAs are not the only substances that affect the refractive index of a solution. The potential for obtaining invalid results is therefore quite high and the method should therefore be used with considerable caution. It would therefore be advisable to recalibrate in case of doubt. The provision to control the calibration of the PAH/PCA ratio every six months is to safeguard the validity of the IP346 results against unintentional or unknown changes. This would apply for the case where the manufacturing process and materials used remain the same, and where there is no reason be expect a change in the PAH/PCA ratio. However, it is possible to imagine, for example, that a tyre manufacturer receives a reformulated extender oil from his supplier without being made aware of the change that has been made, and the results from the IP346 could be invalidated as a consequence. A six month recalibration interval was considered sufficient to cover such occurrences. Conclusion: The provision to control the calibration of the PAH/PCA ratio after each "major operational change" is to safeguard the validity of the IP346 results. A major operational change is therefore a deliberate change to materials or processes that might be expected to significantly influence the PAH/PCA ratio, or otherwise affect the validity of the measurement. Examples of such a change would be where the source of supply for the extender oil is changed, or where the method of using the oil is changed. Judgment of whether a particular change is sufficiently important to trigger the need for recalibration will necessarily be made case-by-case and will require expert opinion.

Standard reference tyres are produced and imported solely for the purpose of providing a reference performance for other newly developed tyres. They are not placed on the market to be fitted on vehicles intended for final users. For the purpose of entry 50, tyres are defined as tyres for vehicles covered by Directives 2007/46/EC on motor vehicles and their trailers, Directive 2003/37/EC on agricultural or forestry tractors, and Directive 2002/24/EC on two and three-wheeler motor vehicles. It appears that Reference Tyres are not intended to be used on vehicles covered by the Directives 2007/46/EC, 2003/37/EC and 2002/24/EC. In conclusion these tyres should not be considered as covered by the provisions of the restriction in Entry 50 of Annex XVII.

This document aims at providing a guideline concerning the interpretation of the scope of the restriction provisions in paragraphs 5 and 6 of entry 50 of Annex XVII to REACH Regulation (EU) No 1907/2006 on polycyclic aromatic hydrocarbons in articles supplied to the general public. It has been drawn up to (i) clarify certain terms that define the scope of the restriction (e.g. “plastic and rubber component”, “direct as well as prolonged contact or short-term repetitive contact with human skin or the oral cavity", "normal/reasonably foreseeable conditions of use") and (ii) provide non-exhaustive lists of article types which fall within (or out of) the scope of the restriction.

The threshold of 0.1% is the standard threshold used in Annex XVII. The value of 0.1% has been chosen because it represents a measurable quantity. It is being used to take into account impurities, not to allow the use of certain substances, e.g. phthalates in toys and childcare articles. One should be aware that in order to plasticise a toy or childcare article concentrations of phthalates of more than 10 per cent are needed. Different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, i.e. the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%. Conclusion: A toy or childcare article would not comply with the Entry 51 or Entry 52 respectively if it contained either more than 0.1% of DEHP, DBP and BBP combined or more than 0.1% of DINP, DIDP and DNOP combined. However, it would be considered compliant if it contained only 0.09% of DEHP, DBP and BBP combined and 0.09% of DINP, DIDP and DNOP combined.

The entries 51 and 52 specify that "Childcare article" means "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children." As these articles are intended to facilitate the hygiene of children they should be considered as "childcare articles" as defined by the entries 51 and 52. In conclusion, articles which are used for the hygienic care of children such as bathtubs, articles for the bath, bathtub mats, hairbrushes, bath thermometers, or nail cutters are therefore covered by the Entries 51 and 52 and use of phthalates and should conform to the prescriptions of the entries.

The definition of childcare articles contained in Annex XVII to REACH is as follows: "Childcare articles" are defined as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children". Further explanation is provided by the Commission services' guidance document on the interpretation of the concept "which can be placed in the mouth". It gives the following examples: "The main purpose of pyjamas is to dress children when sleeping and not to facilitate sleep. Pyjamas should therefore be regarded as textiles and, like other textiles, do not fall under the scope of the Directive. Sleeping bags are designed to facilitate sleep, and should therefore fall under the Directive." Taking this into account, and also taking into account that the guidance document explicitly contains a description and a photo of a mattress cover, it can be confirmed that mattress protectors are childcare articles as defined in Annex XVII. This means that the three phthalates DEHP, BBP and DBP listed in entry 51 of Annex XVII may not be used in mattress protectors. The other three, DINP, DIDP and DNOP, listed in the entry 52, are only restricted in those articles that can be placed in the mouth by children.

The guidance document contains an example of a mattress cover that is not directly mouthable in normal and foreseeable use conditions. The edges and corner are not accessible for mouthing by the child – by design (the mattress should fit snugly in the cot to avoid entrapment risks), and the mattress is covered with a sheet in normal use and the surface is sufficiently taut (by design – to avoid suffocation risks) to prevent PVC from being mouthed through the sheet. This is based on the observation that inaccessible parts of articles can not be taken into the mouth. Articles or parts of articles should be considered inaccessible if, during proper use or reasonably foreseeable improper use by children, they can not be reached. However, there will be other cases when parts of certain articles can be taken into the mouth under normal and foreseeable conditions, for example when the mattress protector is placed on the sheet or cannot be completely fixed. In conclusion, mattress protectors that can be placed above sheets or that cannot be tightly fixed to the mattress have to comply with the restriction contained in entry 52 of Annex XVII to REACH. Authorities competent for market surveillance should assist manufacturers/importers in making a case-by-case assessment on the basis of the criteria described above and in the guidance document.

The restriction in entry 52 concerns the substance "Di-isodecyl phthalate" (DIDP) which is listed with CAS Numbers 26761-40-0 and 68515-49-1. Di-2-propyl heptyl phthalate (DPHP) is an isomer of decyl phthalate and has the CAS No 53306-54-0. According to the information at the Commission's disposal, DPHP (CAS # 53306-54-0) is different from DIDP and therefore not covered by entry 52 of Annex XVII. In conclusion, the substance is not covered under the entry 52 of Annex XVII. The uses of the substance may be regulated in the future on a Community-wide basis, if it appears from the information which will become available that it causes unacceptable risks to human health or the environment. In addition DPHP is explicitly not promoted by its manufacturers for use in toys, food packaging or medical products.

Guideline on the interpretation of the concept "which can be placed in the mouth" as laid down in the entry 52 of Annex XVII to REACH Regulation 1907/2006.

This guideline aims at providing some criteria and examples to help identify those toys and childcare articles which can be placed in the mouth by children. The guideline lists the main criteria of "size dimension" and "accessible parts" (according to the EN 71-European Standard on the safety of toys) which would therefore facilitate the judgement - on a case by case – whether a toy or childcare article can be placed in the mouth by children.  The guideline also provides pictures as examples in order to better indicate which toys and childcare articles or parts of them can be taken into the mouth.  

The 0.1% limit was set up in order to eliminate the use of phthalates. Such limit was set up in order to be respected in each bit/piece of plasticised material by itself, regardless of whether there are other pieces or not. Therefore the reference to 0.1%, intended also as the sum up to the 3 phthalates, has to be calculated in each piece of plasticised material of each homogenous material. In the example referred to in the question the calculation should therefore be based on the weight of the plasticised material of the head of the doll and not the entire weight of all plasticised material of the whole toy.

A childcare article is defined by entries 51 (4) and 52(4) as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children" (see Q&A 983). A baby monitor does not facilitate the sleep or relaxation of the baby, it allows parents to be alerted when the baby is crying or making other noise. Therefore baby monitors fall outside the scope of entries 51-52 of Annex XVII.

No, items such as school supplies, clothing or hair accessories are not considered as toys in the sense of the Directive 2009/48/EC on the safety of Toys, as their main purpose is not to be used in play by the children. However, certain products such as plastic combs can fall under the definition of ‘childcare articles’ (defined in the restriction as any products intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children) see (Q&A 0983). 

Medical devices are defined in Article 2 of Regulation (EU) 2017/745 (see: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#current_legislation). Entries 51 and 52 pose restrictions on certain phthalates in plasticised materials in toys and childcare articles. Medical devices are generally regarded to have functions different from those of toys and childcare articles. Childcare articles are defined in entries 51 and 52 as ‘…any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of the children’. Whether a medical device is a childcare article for the purpose of entries 51 and 52 should be assessed on a case-by-case basis. In the example of a nebuliser, the device is intended for administering a medicinal product (apparatus to be used for treatment) and therefore it is not a childcare article and the restriction does not apply to it.

The polymeric MDI, with CAS number 9016-87-9, is not included in the definition of the substance with CAS 26447-40-5 and moreover is not classified as dangerous in Annex VI of Regulation (EC) No 1272/2008 (CLP). In the Risk assessment report and Risk reduction strategy performed by the Belgian Rapporteur, two main products were analysed during the exposure assessment and throughout the decision making process: the one-component foams and hot melt adhesives, both containing respectively 10% and 2% of MDI. Other products with MDI content below 0.1% did not pose any risk and therefore were excluded by the final consideration on the risk reduction measures under Directive 76/769/EEC. However, polymeric MDI present in mixtures is covered by the restriction when such mixtures contain more than 0.1% of MDI (as defined in the RAR). Therefore, dimers and polymeric forms of MDI are out of the scope of the current restriction except if they are part of mixtures containing more than 0.1% of MDI.

In entry 58, the terms "including natural or legal persons licensed or authorised in accordance with Council Directive 93/15/EEC" should be read as an example of operators that benefit from the exemption. Therefore the derogation in paragraph 2(a) covers all downstream users and distributors as defined in Article 3(13) and 3(14) of REACH. As a consequence, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may be placed on the market after 27 June 2010 for supply to downstream users and distributors as defined in REACH. As consumers are not downstream users nor distributors, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may not be placed on the market for supply to consumers.

If a downstream user uses ammonium nitrate to produce a mixture containing ammonium nitrate below the threshold, it may place this mixture on the market for supply the general public. But downstream users should not use ammonium nitrate in order to produce a mixture containing ammonium nitrate above the threshold for supply to the general public. The restriction is applicable to medical devices as well as to other mixtures containing more than 16% of nitrogen in relation to ammonium nitrate for supply to the general public. For example, instant cold packs which contain more than 16% of nitrogen in relation to ammonium nitrate may not be sold to the general public since 27 June 2010.

The restriction is not applicable to downstream users who use ammonium nitrate for their industrial or professional activities in order to transform it into other substances for different purposes. Therefore, for example the use of ammonium nitrate to produce nitrous oxide for use in the production of pressurised foods or for use as anaesthetics is not restricted.

No. Ink strippers, adhesive removers and degreasing agents are not within the scope of the restriction. The restriction covers paint strippers, including also varnish removers and lacquer removers.

This document echa.europa.eu/documents/10162/13563/lead_guideline_information_en.pdf aims at providing a guideline concerning the interpretation of the scope of the restriction provisions in paragraphs 7 to 10 of entry 63 of Annex XVII to REACH Regulation (EU) No 1907/2006 on lead and its compounds in articles supplied to the general public. It has been drawn up to (i) clarify certain terms that define the scope of the restriction (e.g. "accessible part of articles", "normal/reasonably foreseeable conditions of use") (ii) provide non-exhaustive lists of article types (and examples of sub-types) which fall within (or out of ) the scope of the restriction.

The substances affected by this restriction are those described in column 1 of entry 68. There are many substances that meet the criteria in column 1 of entry 68 and as such it is difficult to produce a comprehensive list of these substances. Further explanatory information on the scope of this restriction may be found on pages 28-41 of the compiled RAC/SEAC opinion from the restriction procedure on the ECHA website here: https://echa.europa.eu/documents/10162/13641/rest_pfoa_compiled_opinions_en.pdf/2f0dfce0-3dcf-4398-8d6b-2e59c86446be

In addition, Appendix B.1 of the Background Document to the compiled RAC/SEAC opinion from the restriction procedure lists examples of PFOA-related substances here:
https://echa.europa.eu/documents/10162/13641/rest_pfoa_final_bd_en.pdf/61e81035-e0c5-44f5-94c5-2f53554255a8

Perfluorooctane sulfonic acid (PFOS) and its derivatives are specifically exempted by paragraph 4(a) of entry 68. This is to avoid double regulation as PFOS is widely restricted in the EU by Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants (as amended by Commission Regulation (EU) No 757/2010).

The term ‘related substance’ or ‘PFOA-related substance’, refers to a substance that, based upon its molecular structure, is considered to have the potential to degrade or be transformed to PFOA. This is described in footnote 2 to Commission Regulation (EU) 2017/1000 amending Annex XVII of REACH to add entry 68. In addition, the description of any related substance in column 1 is applicable.

From 4 July 2020 the concentration limit ‘equal to or above 25 ppb’ applies to the use of perfluorooctanoic acid (PFOA, CAS 335-67-1, EC 206-397-9) and its salts in the production of, or placing on the market in, another substance, as a constituent, a mixture or an article.

From 4 July 2020, the concentration limit of ‘equal to or above 1000 ppb’ applies to the use of one or a combination of PFOA-related substances that are identified in the second and third paragraphs of column 1 in the production of, or placing on the market in, another substance, as a constituent, a mixture or an article. The following PFOA-related substances are identified in the second and third paragraph of column 1:

• Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C₇F₁₅- directly attached to another carbon atom, as one of the structural elements’.
• Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C₈F₁₇- as one of the structural elements’.

A useful discussion of the rationale for these concentratrion limits is given on pages 30-31 of the compiled RAC/SEAC opinion from the restriction procedure on the ECHA website here:
https://echa.europa.eu/documents/10162/13641/rest_pfoa_compiled_opinions_en.pdf/2f0dfce0-3dcf-4398-8d6b-2e59c86446be.

The restriction entry 68, paragraph 3(b)(i) provides a longer transition period for textiles used to protect workers from risks to their health and safety, i.e. paragraphs 1 and 2 shall apply from 4 July 2023 to the use of PFOA and PFOA related substances in the production of, or placing on the market in such textiles. This transition period is thought to be sufficient time to allow the development of cost-effective alternatives for all relevant applications where the textiles are required to provide human health/life protecting functions (e.g. due to very strong oil or chemical repellence).

The workers requiring this type of protection are e.g. firefighters, policemen that are exposed to risks from oil and chemicals and therefore need personal protective equipment, as well as workers in the healthcare sector. A non-exhaustive list of clothing for worker protection that need to comply with the restriction is given in Appendix B.2.2.5 of the final background document supporting the RAC and SEAC opinions. The list includes high visibility jackets, flame-retardant trousers and surgical gowns and is available here:
https://echa.europa.eu/previous-consultations-on-restriction-proposals/-/substance-rev/1908/term.

The substances restricted by the entry (column 1) shall not be used in the production of, or placed on the market in fire-fighting foam mixtures from 4 July 2020 (paragraph 2(b)) at or above concentrations specified in the entry. However, the concentration limits in the restriction (column 2, paragraph 2) do not apply to fire-fighting foam mixtures (paragraph 5(a)), placed on the market before 4 July 2020.

The restriction does not apply to the concentrated fire-fighting foam mixtures that are placed on the market before 4 July 2020 and which are to be used or are used in other fire-fighting foam mixtures (paragraph 4(e)). Thus concentrated fire-fighting foam mixtures that exceed the concentration limits specified in paragraph 2 of the entry can still be used in the production of other fire-fighting foam mixtures, if these concentrated fire-fighting foam mixtures were placed on the market before 4 July 2020. 

In addition, fire-fighting foam mixtures produced using the above mentioned concentrated fire-fighting foam mixtures can be placed on the market. They can be used for training purposes provided that the emissions to the environment are minimised and effluents collected are safely disposed of.

The substances restricted by the entry (column 1) shall not be used in the production of, or placed on the market in medical devices other than implantable medical devices within the scope of Directive 93/42/EEC (to be replaced with Regulation (EU) 2017/745) from 4 July 2032 (column 2, paragraph 3 (c)) at or above the concentrations specified in the entry.

There is a derogation for implantable medical devices that are within the scope of Directive 93/42/EEC (to be replaced with Regulation (EU) 2017/745) in the following terms:

• The restricted substances are allowed to be manufactured and placed on the market and used or placed on the market as a constituent of another substance or in a mixture for the production of these devices (paragraph 4(d)(i)) and
• Implantable medical devices produced according to paragraph 4(d)(i) can be placed on the market without specific concentration limits (paragraph 6(b)).

No. The derogation applies only to the manufacture of a fluorochemical substance with a carbon chain equal to or shorter than 6 atoms where PFOA occurs as an unavoidable by-product. The derogation does not apply to substances, mixtures or articles as placed on the market.

Yes, the substances in column 1 shall not be placed on the market in, or used in the production of cosmetics.

Article 67(2) REACH foresees that Annex XVII restrictions do not apply to the use of substances in cosmetic products in the case of restrictions addressing human health risks within the scope of the Cosmetic Products Regulation (Regulation (EC) 1223/2009). This is not the case for entry 68: all substances covered by the restriction are either persistent, bioaccumulative and toxic (PBT) or are considered to have the potential to degrade or be transformed to PFOA. The concentration limits in the restriction ensure the emissions of these substances to the environment are decreased.