Question 26: Please indicate any incoherence (gaps or missing links, overlaps,

1 Open Public Consultation Results

1.3 Detailed analysis

1.3.22 Question 26: Please indicate any incoherence (gaps or missing links, overlaps,

which are under the scope of this fitness check

1.3.22.1 Analysis of open text responses

There was no closed element to this question. Respondents were also asked to focus on aspects related to hazard identification, risk assessment and risk management of chemicals. In total, 39 comments in relation to gaps and missing links, 39 comments related to overlaps and 41 comments on inconsistencies were reviewed.

The samples for Question 26 were taken for each of the text boxes on gaps, overlaps, and inconsistencies, thus there are around three times as many comments that have been reviewed as for the other questions. This ensures that equal weight is given to responses on each of the possible types of incoherence. Some comments covered overlaps or inconsistencies in the box for gaps, overlaps in the box for inconsistencies, etc. Therefore, the results for Question 26 have been presented together rather than providing a separate analysis on gaps, overlaps and inconsistencies for each text box. This ensures a more comprehensive assessment across all sampled responses.

The key themes from these comments have been extracted and are summarised in Table 1-64. The table also shows which groups the comments were from.

Table 1-64: Q26: incoherence between different pieces of legislation under the scope of the fitness check themes from non-questionnaire responses (Gaps: n=39; Group 1 (citizens) = 5, Group 2 (industry) = 20, Group 3 (public authority) = 6, Group 4 (NGO/others) = 8; Overlaps: n=39; Group 1 = 5, Group 2 = 22, Group 3 = 6, Group 4 = 6; Inconsistencies: n=41; Group 1 = 4, Group 2 = 24, Group 3 = 6, Group 4 = 7)

Theme By

Themes on gaps and omissions

Too little account of new risks Group 1 (citizen)

Maximum residue limits between pesticides and biocides Group 3 (public authority) Better transfer of information on hazardous substances to the waste section Group 3 (public authority) Clear definition of criteria for endocrine disruptors Group 3 (public authority)

Group 4 (NGO/others) Gaps in and between specific legislation (no details given) Group 2 (industry)

Food contact materials Group 2 (industry)

Group 4 (NGO/others) Cosmetics Products Regulation outlines specific safety assessment procedures

that cannot always be found in other legislation Group 2 (industry)

CLP packaging requirements Group 2 (industry)

Classification of mixtures Group 2 (industry)

Group 4 (NGO/others) Additional steps needed in risk management of active substances for biocides

to allow for cost-benefit analysis Group 2 (industry)

Carcinogens and Mutagens Directive does not cover substances toxic for Group 2 (industry)

Theme By

reproduction Group 4 (NGO/others)

Gaps in communication along the supply chain Group 2 (industry) Missing connections relating to hazard characteristics and those relating to risk

assessment Group 2 (industry)

Gaps for specific substances Group 4 (NGO/others)

Gap concerning evaluation and reporting on chemicals in low volumes Group 4 (NGO/others) Gap in chemical regulations and content information to consumers for the

majority of consumer goods Group 4 (NGO/others)

Exposure of consumers to hazardous chemicals in imported articles and goods

is not adequately addressed Group 4 (NGO/others)

No clear limit value on content of chemicals in medical devices Group 4 (NGO/others) Setting standards for emission of pollutants in indoor air Group 4 (NGO/others) Drinking Water Directive needs to be enhanced to improve chemical safety of

water supply materials Group 4 (NGO/others)

Themes on overlaps and duplications

Unclear boundaries between IED¹ and Urban Waste Water Directive and Water

Framework Directive need to be addressed Group 3 (public authority)

Same substances could be notified and/or evaluated under different legislative

frameworks Group 2 (industry)

PPP² requires full risk assessment but this can be overridden by classification if

the risk assessment indicates safe use Group 1 (citizen)

Overlaps between directives/regulations (but no details given)

Group 1 (citizen)

Group 3 (public authority) Group 2 (industry) Group 4 (NGO/others) PG2 and 5 overlap with well-functioning and implemented national regulation

and laws Group 1 (citizen)

Same chemicals can be covered by CLP, biocides and plant protection products regulations and different outcomes can be reached even with the same dataset

Group 3 (public authority) RoHS³ and toys directive have same substances regulated Group 3 (public authority) Double regulation of dioxins/furans in POP⁴ regulation and national

ChemVerbotsV Group 3 (public authority)

Classification and labelling requirement has unduly become reference for

waste classification Group 2 (industry)

Substances on the candidate list and POP regulation Group 2 (industry) RoHS and REACH have substance related overlaps Group 2 (industry) Some instances of double regulation due to legislative changes or guidance Group 4 (NGO/others) Themes on inconsistencies and conflicts

Preventing hazardous substances getting into materials and products Group 3 (public authority)

Use of SVHC⁵ is hindering recycling Group 3 (public authority)

Different approaches at national level to nanomaterials Group 2 (industry) Group 3 (public authority)

Theme By

Tighter hazard categories in Seveso Directive from CLP will result in more

substances falling under Seveso requirements Group 2 (industry) Classification can be very different for one product for human use Group 2 (industry) CLP values are not suitable to set safe rules for chemical use in toys Group 4 (NGO/others)

Substance restrictions with different rules Group 2 (industry)

Changes in CLP environmental classification automatically triggers

requirements under Seveso III and there is no assessment as to whether these requirements are appropriate in risk management terms

Group 2 (industry)

Incorrect application of Article 15 of Cosmetics Products Regulation creates an overlap with CLP which leads to inconsistency

Group 2 (industry) Risk assessment used in some cases risk management by hazard identification

in Group 4

Group 1 (citizen) Group 2 (industry) Directives should be united in regulations and directly implemented at national

level Group 1 (citizen)

Inconsistencies between regulations/directives (no further details given)

Group 1 (citizen)

Group 3 (public authority) Group 2 (industry) Controls on biocides and plant protection products are more restrictive than

on general chemicals due to classification based exclusion criteria Group 3 (public authority) Harmonised definition of nanomaterials is needed Group 3 (public authority)

Group 4 (NGO/others) Ban on animal testing for cosmetics but biocides regulation specifically asks for

animal testing Group 3 (public authority)

Issue of animal testing in cosmetics regulation versus other regulations Group 2 (industry) PBT⁶ assessment is not consistent within different parts of the legislation Group 3 (public authority) Difference in classification of substances between transport and supply and

use Group 3 (public authority)

Divergence between commitment to weight-of-evidence considerations and

how substances are identified as PBT/vPvB⁷ Group 2 (industry)

Different migration limits for same chemicals for different FCM⁸ Group 2 (industry) The influence of individual views of Member States Group 2 (industry) CLP has led to unpredicted burden for waste management Group 2 (industry) Waste legislation might be inconsistent with REACH for recycling purposes Group 2 (industry)

OELs⁹ vary from country to country Group 2 (industry)

Glass is a substance and should not be subject to RoHS Group 2 (industry) Risk assessment principles differ in Toy Safety Directive and Cosmetics Product

Regulation with regard to treatment of children Group 2 (industry) There are inconsistencies between labelling of substances under CLP and some

sectoral legislation (biocides, detergents) Group 2 (industry)

Inconsistency of restrictions in POP regulation Group 2 (industry) Regulation on marketing and use of explosives is inconsistent with statistical

and physical measurement bases Group 2 (industry)

Not all inconsistencies between different legislation are negative Group 4 (NGO/others)

Theme By

Lists of substances in different pieces of legislation should be harmonised Group 4 (NGO/others) CLP has no de minimis exemption unlike Dangerous Goods directive Group 4 (NGO/others) Themes on labelling

Labelling requirements under different pieces of legislation need to be better

integrated to facilitate compliance Group 2 (industry)

Inconsistent labelling requirements Group 2 (industry)

Detergents Regulation has its own labelling requirements beyond what is required according to CLP

Group 3 (public authority) Group 2 (industry) CLP and plant protection regulation/biocidal products have different

requirements for advertising and labelling Group 3 (public authority) Labelling requirements in transport of dangerous goods, in CLP and in national

authorities requirements Group 2 (industry)

Labelling under BPR¹⁰ and CLP for treated articles Group 2 (industry) Classification and labelling differs between ADR¹¹ and CLP Group 2 (industry) Themes on coordination with other legislation

Automatic legal consequences in downstream legislation should be avoided Group 2 (industry) Need for visual mapping and overview of broader architecture and vertical and

horizontal linkages between different legislation Group 2 (industry) Derogation of glass under RoHS should not be reopened by REACH

authorisation process Group 2 (industry)

When a substance is restricted in regulation X, this should trigger a restriction

in regulation Y, Z and evaluation in regulation A, B, C Group 4 (NGO/others) Themes on definitions

Coherent definitions of hazardous substances Group 3 (public authority) Group 2 (industry)

There is not always a common definition Group 2 (industry)

Other themes

Risk assessment should be studied by a laboratory independent of the

manufacturer Group 1 (citizen)

Set of shared references Group 1 (citizen)

Product bans Group 1 (citizen)

Risk assessment issues Group 3 (public authority)

Ignorance of users Group 2 (industry)

Not all substances in Seveso are capable of uncontrolled or spontaneous

release of energy or matter* Group 2 (industry)

Chemical producers should not undertake the evaluation of risks Group 1 (citizen)

Notes: *This is not considered an inconsistency, as Seveso intentionally includes substances that can initiate or aggravate the effects of a major accident.

1 IED = Industrial Emissions Directive. ² PPP = Plant Protection Product. ³ RoHS = Restriction of Hazardous Substances Directive. ⁴ POP = Persistent Organic Pollutant. ⁵ SVHC = Substances of Very High Concern. ⁶ PBT

= Persistant, Bioaccumulative, Toxic. ⁷ vPvB = very Persistent very Bioaccumulative. ⁸ FCM = Food Contact Materials. ⁹ OEL = Occupational Exposure Limit. ¹⁰ BPR = Biocidal Products Regulation. ¹¹ ADR = European Agreement concerning the International Carriage of Dangerous Goods by Road

1.3.22.2 Themes from analysis of sample of non-questionnaire responses

As well as the responses from the OPC, an analysis was made of the themes from nine other responses that were received. Table 1-65 provides a summary of the themes from these non-questionnaire responses.

Table 1-65: Q26: incoherence between different pieces of legislation under the scope of the fitness check themes from non-questionnaire responses (n=9)

Theme By

Themes on gaps and omissions

There is a gap in the requirements for toys Group 3 (public authority) Additional steps in risk management of active substances are needed for

biocides Group 2 (industry)

There is no provision within Regulation EC 396/2005 to enable MRLs¹ to be set

for BPR² product Group 3 (public authority)

Gaps, overlaps, confusions and contradictions creep into the text during

negotiations which are not intended Group 3 (public authority)

Themes on overlaps and duplications

The same substance must be assessed for both PPP³ and BP Regulations Group 3 (public authority) Hazard assessment of the same substances under both Regulation (EC) no

1107/2009) and Regulation (EU) no 528/2012 should be avoided Group 3 (public authority) Article 69(1) BPR (Regulation EU no 528/2012) refers to the provisions of CLP,

including requirements to have labels in the national languages (art. 17(2) CLP). The same issue is dealt with in art. 69(3) BPR

Group 3 (public authority) The Detergents Regulation has its own additional labelling requirements

beyond what is required according to CLP Group 3 (public authority)

The demands are unnecessary since CLP entered into force and it could be

removed Group 3 (public authority)

Both CLP and the Plant Protection Products Regulation/Biocidal Products

Regulation have rules regarding for example advertising and labelling Group 3 (public authority) The RoHS⁴ Directive and the Toys directive have the same substances

regulated Group 3 (public authority)

Creosote between BPR and REACH Group 3 (public authority)

The large number of separate directives for specific issues e.g. toys, adds to the

complexity Group 3 (public authority)

The parallel existence of hazard reviews under the CLP, BPR and PPP schemes

can prove to be very ineffective and impacting resources Group 2 (industry) None of the three legal texts (CLP, Biocides, and REACH Regulations) foresee a

timely sequence or practical code of work to maximise the use of generated data and the efficiency of the overall classification process

Group 2 (industry) Neither do methodologies documented under one benefit the other. Group 2 (industry) This may result in classifications decided on the basis of incomplete or

non-fit-for-purpose datasets Group 2 (industry)

The hazard assessment for BPR, PPPR and REACH and CLP leads often to

double or multiple work Group 2 (industry)

We should move from an ad hoc system in which classification proposals are submitted under different umbrellas (e.g. Biocides, CLP, etc.), to a more systematic and integrated system.

Group 2 (industry) Article safety legislation is far from harmonised and streamlined Group 2 (industry) Themes on inconsistencies and conflicts

The derogation for medical devices which are invasive in CLP is not written in

the same way as in REACH Group 3 (public authority)

Table 1-65: Q26: incoherence between different pieces of legislation under the scope of the fitness check themes from non-questionnaire responses (n=9)

Theme By

The properties of PFAS⁵ do not fit in the criteria laid down by REACH Annex

XVIII Group 3 (public authority)

There is a divergence between the commitment to weight-of-evidence

considerations and how substances are being identified as PBTs⁶/vPvBs⁷ Group 2 (industry) When it comes to PBT/vPvB criteria the consequences of fulfilling the criteria

are very different. For REACH no immediate consequences; for PPP non-authorisation. The difference in consequences leads to differences in interpretation

Group 3 (public authority)

Regulatory efforts and costs varies significantly between different legislations Group 3 (public authority) The whole REACH system became utterly complex with all the different

substances ‘statuses’ Group 2 (industry)

This could be simplified to a great extent by focussing on the potential for and

pathway of exposure Group 2 (industry)

Themes on labelling

Labelling requirements could be better integrated Group 2 (industry) Labelling requirements under BPR and CLP are sometimes contradictory Group 2 (industry) In the BPR the risks from products might be the same but the extent to which

they are regulated depends upon the claims made on the label Group 3 (public authority) Themes on coordination with other legislation

Monitoring data from other legislation would be useful (e.g. WFD⁸) Group 3 (public authority) Need to highlight issues for other legislation where water bodies do not fulfil

criteria of WFD Group 3 (public authority)

Needs to be more coordination between WFD and other legislation Group 3 (public authority) REACH datasets are often disregarded in Member State and EU policies, such

as the Water Framework Directive, IED and OSH⁹ where they are not yet fully recognised as reliable references

Group 2 (industry) Better integration is needed with EU rules on chemicals, articles and waste Group 3 (public authority) It is not possible for EU-authorities to get data on the use of ingredients in

cosmetics Group 3 (public authority)

Themes on definitions

The term “ingredients” is not defined in CLP leading to unclear legal text Group 3 (public authority) Article 1(5) CLP is not clear with regard to the scope of the exemption from CLP Group 3 (public authority) Reg (EC) no 1107/2009 and Reg (EC) no 1272/2008 are vague as to the

designating responsibility to produce classification dossiers Group 3 (public authority) Same definitions can mean different things in different legislations Group 3 (public authority) Better to have rules that impose the same restrictions on all items Group 3 (public authority) Other themes

Automatic legal consequences to more substances falling under Seveso

requirements should be avoided Group 2 (industry)

Evaluation process for active substances in PPP and CLH¹⁰ process need to be

re-examined Group 3 (public authority)

The approach indicated by the legislator for 'cut off criteria' is not followed in

practise. Group 3 (public authority)

It is not clear that the legislation leads to substances that stay on the market

are safer than the ones that are removed Group 3 (public authority)

Somewhat unclear or illogical structure of the chemicals legislation in EU

particularly in relation to the legislation concerning substances and mixtures in Group 3 (public authority)

Table 1-65: Q26: incoherence between different pieces of legislation under the scope of the fitness check themes from non-questionnaire responses (n=9)

Theme By

articles (products)

Make better use of self-classifications and to discuss at expert panel level or a broader/more integrated and dynamic group, only self-classifications deviating from the classification rules

Group 2 (industry) Mutual recognition of legislation on food contact materials is not working

effectively Group 2 (industry)

Limit values in different legislations are potentially overlapping and incoherent Group 3 (public authority) Notes: ¹ MRL = Maximum Residue Limit. ² BPR = Biocidal Products Regulation. ³ PPP = Plant Protection Product. ⁴ RoHS = Restriction of Hazardous Substances Directive. ⁵ PFAS = Perfluorinated alkylated substances. ⁶ PBT = Persistant, Bioaccumulative, Toxic. ⁷ vPvB = very Persistent very Bioaccumulative. ⁸ WFD = Water Framework Directive. ⁹ OSH = Occupational Safety and Health. ¹⁰ CLH = Harmonised Classification and Labelling

1.3.22.3 Comparison of themes

The themes associated with the incoherence between different pieces of legislation are summarised in the table below. Here the themes focus on the regulations and directives where gaps, overlaps and inconsistencies have been identified. Not all comments provide further details as to what the gap is, where the overlaps are or why there are inconsistencies. Those regulations and directives listed in Table 1-66 that were not included as themes in Tables 1-64 and 1-65 are where no further detail has been provided. Therefore, the table provides a summary of the types of issues identified and the number of times each was reported. Note the count is the number of comments that were attributed to each theme, not the number of respondents. This means one respondent could be counted more than once in the sample if, for example, they made comments that were used in two or more themes. Further details on the gaps, overlaps and inconsistencies are set out below the table, where these were provided by respondents.

Table 1-66: Comparison of responses on incoherence between different pieces of legislation under the scope of the fitness check

Non-questionnaire responses OPC responses

Regulation/directive(s) By Regulation/directive(s) By

Regulations and directives where gaps were identified

Toys Group 3 (1) Cosmetic Products

Regulation and other legislation

Group 2 (1)

Biocides Group 3 (1) CLP packaging

requirements

Group 2 (1) Carcinogen and

Mutagens Directive

Group 2 (1) Group 4 (1) Regulations and directives where overlaps were identified

PPPR¹ and BPR² Group 3 (2) Biocides and pesticides Group 4 (1)

BPR and CLP Group 3 (1) CLP and BPR Group 1 (1)

Group 4 (1) BPR and REACH

(creosote)

Group 3 (1) PPPR, BPR and CLP Group 3 (1)

Group 2 (1)

CLP, biocides, PPPR Group 3 (1) CLP, biocides and REACH Group 2 (1)

Table 1-66: Comparison of responses on incoherence between different pieces of legislation under the scope of the fitness check

Non-questionnaire responses OPC responses

Regulation/directive(s) By Regulation/directive(s) By

PPPR, BPR, CLP and

exposure values (DNEL⁷, OEL⁸, European and Regulations and directives where inconsistencies and conflicts were identified

Medical devices, CLP and Cosmetic Products Group 2 (2)

Table 1-66: Comparison of responses on incoherence between different pieces of legislation under the scope of the fitness check

Non-questionnaire responses OPC responses

Regulation/directive(s) By Regulation/directive(s) By

Regulation and CLP CLP and transport regulations

Group 2 (1) Drinking Water Directive,

BPR

Group 1 (1) Contaminants in food,

MSFD⁹, IED

Group 3 (1) CAD¹⁰ and CMD¹¹ Group 2 (1)

RoHS Group 2 (1)

National legislation versus EU legislation

Group 2 (1)

Key: Group 4 captures non-governmental organisation (NGO), consumer association, trade association, trade union, academia or a research or educational institute, other from Question 5 of the OPC.

Notes: ¹ BPR = Biocidal Products Regulation. ² PPPR = Plant Protection Products Regulation. ³ RoHS = Restriction of Hazardous Substances Directive. ⁴ ELV = End of Life Vehicles Directive. ⁵ IED = Industrial Emissions Directive. ⁶ POP = Persistent Organic Pollutant. ⁷ DNEL = Derived No Effect Level. ⁸ OEL = Occupational Exposure Limit. ⁹ MSFD = Marine Strategy Framework Directive. ¹⁰ CAD = Chemical Agents Directive. ¹¹ CMD = Carcinogens and Mutagens Directive.

Some of the comments provided just a short summary of the issue without providing any further information. Others, though, provided a detailed discussion of the problem. Examples of key points are provided below:

 Comments on gaps and omissions:

o While we agree it can be useful to look for current gaps and missing links in current legislation, we hold the view that not all inconsistencies are bad by definition. There can be good reasons to adapt rules to specific chemical uses or intrinsic hazardous properties. For example, the use of generic risk assessments to phase out chemicals with the most harmful properties from applications with clear exposure of people, including children (Group 3);

o Need to speed up the process of including restrictions for use of certain chemicals in packaging materials, batteries and vehicles in line with the new information on hazards and risks that is generated e.g. under REACH. We propose that a review process should be included in these directives to regularly evaluate the existing limit values and assess the need for including additional substances in the directives

In document Open Public Consultation Results (excerpt from Task 4: Consultation Summary) DG Internal Market, Industry, Entrepreneurship and SMEs. (Page 109-121)